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Evaluation of a Tongue Operated Assistive Technology for Individuals With Severe Paralysis (TDS-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01124292
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : September 10, 2013
Last Update Posted : September 18, 2013
Sponsor:
Collaborators:
Shepherd Center, Atlanta GA
Northwestern University
Shirley Ryan AbilityLab
University of Arizona
Information provided by (Responsible Party):
Maysam Ghovanloo, Georgia Institute of Technology

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Quadriplegia
Spinal Cord Injury
ALS
Interventions Procedure: Tongue Piercing
Device: Usability assessment
Enrollment 61
Recruitment Details

Able-bodied subjects (groups A and B) were recruited by using local IRB-approved flyers, emails, and electronically distributed documents.

Subjects with spinal cord injuries were recruited from the in- and outpatient departments of the Shepherd Center and the Rehabilitation Institute of Chicago.

(May. 2010 - March. 2012)

Pre-assignment Details  
Arm/Group Title Able-bodied Subject With Tongue Piercing Able-bodied Subject Without Tongue Piercing Subjects With Spinal Cord Injury
Hide Arm/Group Description Able-bodied subjects who already have tongue piercing. Able-bodied subjects who willing to receive a tongue piercing for this study. persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Period Title: Overall Study
Started 16 24 21
Completed 14 9 11
Not Completed 2 15 10
Reason Not Completed
Lost to Follow-up             2             4             3
Physician Decision             0             3             2
Withdrawal by Subject             0             6             2
medical issue unrelated to the study             0             0             2
piercing track closed             0             2             1
Arm/Group Title Able-bodied Subject With Tongue Piercing Able-bodied Subject Without Tongue Piercing: Subjects With Spinal Cord Injury Total
Hide Arm/Group Description Able-bodied subjects who already have tongue piercing. Able-bodied subjects who willing to receive a tongue piercing for this study. Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing. Total of all reporting groups
Overall Number of Baseline Participants 14 9 11 34
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 9 participants 11 participants 34 participants
<=18 years
1
   7.1%
0
   0.0%
0
   0.0%
1
   2.9%
Between 18 and 65 years
13
  92.9%
9
 100.0%
11
 100.0%
33
  97.1%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 9 participants 11 participants 34 participants
23.12  (4.85) 22.56  (4.00) 38.30  (10.25) 27.61  (9.72)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 9 participants 11 participants 34 participants
Female
10
  71.4%
5
  55.6%
2
  18.2%
17
  50.0%
Male
4
  28.6%
4
  44.4%
9
  81.8%
17
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants 9 participants 11 participants 34 participants
14 9 11 34
1.Primary Outcome
Title Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Throughput)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".

The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: bits per second
first session using TDS 1.97  (0.44) 2.03  (0.44) 1.54  (0.56)
second session using TDS 2.04  (0.39) 2.22  (0.52) 1.75  (0.42)
third session using TDS 2.34  (0.32) 2.48  (0.51) 1.90  (0.51)
fourth session using TDS 2.37  (0.50) 2.54  (0.48) 2.14  (0.54)
fifth session using TDS 2.44  (0.52) 2.47  (0.54) 2.09  (0.41)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 2.22  (0.51)
first session using keypad 2.85  (0.41) 3.49  (0.68) NA [3]   (NA)
second session using keypad 2.96  (0.45) 3.69  (0.48) NA [3]   (NA)
third session using keypad 3.09  (0.52) 3.84  (0.54) NA [3]   (NA)
fourth session using keypad 3.14  (0.48) 3.81  (0.59) NA [3]   (NA)
fifth session using keypad 3.17  (0.52) 3.84  (0.57) NA [3]   (NA)
first session using mouse 3.89  (0.97) 4.17  (0.68) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
2.Primary Outcome
Title Fitts' Law: Horizontal Tapping Using TDS, Keypad, and Mouse (Error Rate)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Horizontal Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Percentage of Missed Targets (%)
first session using TDS 29.14  (13.96) 23.85  (11.04) 37.84  (21.65)
second session using TDS 24.08  (17.30) 18.36  (10.11) 30.62  (18.02)
third session using TDS 24.64  (14.89) 13.70  (8.14) 28.77  (17.72)
fourth session using TDS 20.74  (14.36) 14.90  (9.34) 24.01  (14.16)
fifth session using TDS 17.96  (10.41) 16.34  (10.26) 18.45  (9.83)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 19.81  (12.63)
first session using keypad 9.49  (7.96) 10.63  (8.35) NA [3]   (NA)
second session using keypad 6.94  (6.21) 8.44  (7.40) NA [3]   (NA)
third session using keypad 6.70  (6.12) 5.97  (3.96) NA [3]   (NA)
fourth session using keypad 5.03  (4.41) 8.12  (6.54) NA [3]   (NA)
fifth session using keypad 4.99  (4.27) 6.24  (5.19) NA [3]   (NA)
first session using mouse 9.24  (11.91) 2.14  (2.14) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
3.Primary Outcome
Title Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Throughput)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".

The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: bits per second
first session using TDS 2.14  (0.41) 2.22  (0.54) 1.44  (0.50)
second session using TDS 2.27  (0.37) 2.54  (0.51) 1.77  (0.54)
third session using TDS 2.31  (0.45) 2.74  (0.30) 1.79  (0.56)
fourth session using TDS 2.44  (0.36) 2.76  (0.45) 1.97  (0.33)
fifth session using TDS 2.61  (0.30) 2.69  (0.49) 2.01  (0.43)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 2.18  (0.60)
first session using keypad 2.84  (0.44) 3.46  (0.61) NA [3]   (NA)
second session using keypad 2.90  (0.56) 3.88  (0.58) NA [3]   (NA)
third session using keypad 3.03  (0.45) 3.85  (0.58) NA [3]   (NA)
fourth session using keypad 3.10  (0.46) 3.96  (0.65) NA [3]   (NA)
fifth session using keypad 3.11  (0.54) 3.93  (0.41) NA [3]   (NA)
first session using mouse 4.28  (0.71) 4.32  (0.63) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
4.Primary Outcome
Title Fitts' Law: Vertical Tapping Using TDS, Keypad, and Mouse (Error Rate)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Vertical Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Percentage of Missed Targets (%)
first session using TDS 26.16  (15.39) 19.47  (9.95) 38.95  (19.61)
second session using TDS 21.83  (13.78) 15.88  (11.74) 30.37  (17.31)
third session using TDS 22.72  (12.43) 12.67  (7.52) 26.67  (15.57)
fourth session using TDS 20.30  (13.55) 10.97  (10.06) 23.77  (11.32)
fifth session using TDS 14.77  (11.79) 10.97  (7.71) 21.90  (11.35)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 19.99  (12.44)
first session using keypad 9.91  (8.92) 10.43  (7.80) NA [3]   (NA)
second session using keypad 8.95  (7.91) 8.26  (5.72) NA [3]   (NA)
third session using keypad 6.16  (6.02) 6.41  (5.55) NA [3]   (NA)
fourth session using keypad 5.47  (5.42) 6.00  (4.82) NA [3]   (NA)
fifth session using keypad 5.83  (5.44) 7.27  (6.01) NA [3]   (NA)
first session using mouse 5.02  (7.37) 2.13  (2.28) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
5.Primary Outcome
Title Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Throughput)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".

The high value of throughput means better performance. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: bits per second
first session using TDS 0.83  (0.32) 0.77  (0.48) 0.37  (0.21)
second session using TDS 1.23  (0.36) 0.96  (0.49) 0.52  (0.27)
third session using TDS 1.39  (0.26) 1.10  (0.40) 0.51  (0.31)
fourth session using TDS 1.41  (0.37) 1.29  (0.50) 0.73  (0.45)
fifth session using TDS 1.58  (0.25) 1.41  (0.53) 0.75  (0.45)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 0.81  (0.40)
first session using keypad 1.44  (0.46) 2.13  (0.57) NA [3]   (NA)
second session using keypad 1.74  (0.47) 2.60  (0.44) NA [3]   (NA)
third session using keypad 1.82  (0.29) 2.83  (0.36) NA [3]   (NA)
fourth session using keypad 1.93  (0.32) 3.02  (0.30) NA [3]   (NA)
fifth session using keypad 2.03  (0.27) 3.05  (0.53) NA [3]   (NA)
first session using mouse 3.86  (0.54) 3.31  (0.50) NA [4]   (NA)
first session using SnP NA [5]   (NA) NA [6]   (NA) 0.31  (0.20)
second session using SnP NA [5]   (NA) NA [6]   (NA) 0.42  (0.20)
third session using SnP NA [5]   (NA) NA [6]   (NA) 0.45  (0.19)
fourth session using SnP NA [5]   (NA) NA [6]   (NA) 0.51  (0.16)
fifth session using SnP NA [5]   (NA) NA [6]   (NA) 0.52  (0.17)
sixth session using SnP NA [5]   (NA) NA [6]   (NA) 0.52  (0.19)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
[5]
Group-A subjects did not test using SnP.
[6]
Group-B subjects did not test using SnP.
6.Primary Outcome
Title Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Error Rate)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Percentage of Missed Targets (%)
first session using TDS 37.65  (15.14) 41.41  (20.38) 61.98  (26.32)
second session using TDS 27.33  (12.18) 32.61  (12.51) 55.05  (24.75)
third session using TDS 23.02  (10.47) 23.87  (10.39) 48.15  (25.29)
fourth session using TDS 19.71  (10.80) 25.17  (13.93) 41.44  (23.40)
fifth session using TDS 17.52  (9.15) 19.84  (8.80) 36.54  (22.34)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 39.00  (27.32)
first session using keypad 12.66  (7.67) 6.68  (6.38) NA [3]   (NA)
second session using keypad 11.81  (8.95) 4.86  (6.04) NA [3]   (NA)
third session using keypad 9.67  (7.61) 1.33  (1.51) NA [3]   (NA)
fourth session using keypad 7.69  (5.36) 2.08  (2.57) NA [3]   (NA)
fifth session using keypad 6.72  (4.67) 2.38  (2.40) NA [3]   (NA)
first session using mouse 4.46  (5.63) 2.95  (3.00) NA [4]   (NA)
first session using SnP NA [5]   (NA) NA [6]   (NA) 42.50  (25.34)
second session using SnP NA [5]   (NA) NA [6]   (NA) 31.71  (20.80)
third session using SnP NA [5]   (NA) NA [6]   (NA) 26.67  (19.96)
fourth session using SnP NA [5]   (NA) NA [6]   (NA) 20.69  (15.41)
fifth session using SnP NA [5]   (NA) NA [6]   (NA) 19.83  (18.00)
sixth session using SnP NA [5]   (NA) NA [6]   (NA) 16.52  (12.52)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
[5]
Group-A subjects did not test using the SnP.
[6]
Group-B subjects did not test using the SnP.
7.Primary Outcome
Title Fitts' Law: Center-Out Tapping Using TDS, Keypad, Mouse, and SnP (Movement Time)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Center-out Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The movement time is the cursor movement time from the initial movement to the final movement for each target. This task is tested by the TDS, keypad, mouse and the sip-and-puff device (SnP).

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: seconds
first session using TDS 1.70  (0.30) 1.29  (0.15) 4.00  (1.41)
second session using TDS 1.33  (0.17) 1.22  (0.13) 3.18  (1.44)
third session using TDS 1.30  (0.17) 1.21  (0.11) 3.12  (1.38)
fourth session using TDS 1.34  (0.24) 1.22  (0.15) 2.81  (1.21)
fifth session using TDS 1.26  (0.16) 1.18  (0.08) 2.75  (1.25)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 2.75  (1.24)
first session using keypad 1.29  (0.15) 1.29  (0.39) NA [3]   (NA)
second session using keypad 1.22  (0.13) 0.97  (0.12) NA [3]   (NA)
third session using keypad 1.21  (0.11) 0.95  (0.14) NA [3]   (NA)
fourth session using keypad 1.22  (0.15) 0.88  (0.11) NA [3]   (NA)
fifth session using keypad 1.18  (0.08) 0.87  (0.12) NA [3]   (NA)
first session using mouse 0.66  (0.08) 0.78  (0.07) NA [4]   (NA)
first session using SnP NA [5]   (NA) NA [6]   (NA) 4.48  (1.08)
second session using SnP NA [5]   (NA) NA [6]   (NA) 4.14  (0.90)
third session using SnP NA [5]   (NA) NA [6]   (NA) 3.81  (0.71)
fourth session using SnP NA [5]   (NA) NA [6]   (NA) 3.69  (0.76)
fifth session using SnP NA [5]   (NA) NA [6]   (NA) 3.64  (0.83)
sixth session using SnP NA [5]   (NA) NA [6]   (NA) 3.79  (0.89)
[1]
Group-A subjects completed 5-session trials.
[2]
Group-B subjects completed 5-session trials.
[3]
Group-C subjects could not use a keypad.
[4]
Group-C subjects could not use a mouse.
[5]
Group-A subjects did not test using SnP.
[6]
Group-B subjects did not test using SnP.
8.Primary Outcome
Title Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Throughput)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. This data was then fed into an equation, which provided the throughput measure. The unit of throughput is "bits per second".

The high value of throughput means better performance. Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: bits per second
first session using TDS 0.40  (0.19) 0.80  (0.30) 0.39  (0.17)
second session using TDS 0.62  (0.21) 0.93  (0.31) 0.42  (0.21)
third session using TDS 0.77  (0.30) 1.05  (0.30) 0.45  (0.16)
fourth session using TDS 0.85  (0.32) 1.10  (0.26) 0.65  (0.21)
fifth session using TDS 0.98  (0.26) 1.16  (0.31) 0.64  (0.27)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 0.73  (0.31)
first session using keypad 0.88  (0.28) 1.44  (0.20) NA [3]   (NA)
second session using keypad 1.03  (0.24) 1.69  (0.20) NA [3]   (NA)
third session using keypad 1.11  (0.21) 1.85  (0.17) NA [3]   (NA)
fourth session using keypad 1.19  (0.18) 1.86  (0.22) NA [3]   (NA)
fifth session using keypad 1.16  (0.22) 1.87  (0.23) NA [3]   (NA)
first session using mouse 4.32  (0.59) 4.06  (0.60) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
9.Primary Outcome
Title Fitts' Law: Multi-Directional Tapping Using TDS, Keypad, and Mouse (Error Rate)
Hide Description

Subjects used the tongue drive system (TDS) to move the mouse cursor towards targets with various sizes and distances on the computer screen (Multi-directional Tapping task) and select those targets. The computer measured the time it took for the subjects to reach the targets and the accuracy of their selections from the center of the targets. The error rate is the rate of outside of targets vs. total targets.

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Percentage of Missed Targets (%)
first session using TDS 32.67  (19.60) 21.34  (14.17) 54.91  (22.34)
second session using TDS 21.56  (13.87) 14.27  (9.69) 51.52  (27.88)
third session using TDS 18.42  (14.28) 10.73  (8.48) 37.27  (19.88)
fourth session using TDS 18.00  (15.27) 8.08  (6.67) 27.88  (25.15)
fifth session using TDS 14.67  (13.99) 6.86  (5.52) 29.47  (20.13)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 29.10  (24.28)
first session using keypad 7.25  (7.36) 2.62  (3.38) NA [3]   (NA)
second session using keypad 6.38  (8.73) 1.64  (2.36) NA [3]   (NA)
third session using keypad 3.99  (6.26) 1.30  (2.46) NA [3]   (NA)
fourth session using keypad 3.65  (4.77) 1.84  (2.37) NA [3]   (NA)
fifth session using keypad 4.96  (6.36) 1.44  (2.06) NA [3]   (NA)
first session using mouse 6.77  (7.13) 2.78  (3.21) NA [4]   (NA)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Subjects with Spinal cord injury cannot use the mouse.
10.Primary Outcome
Title Information Transfer Rate (ITR)
Hide Description Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s, SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: bits per minute
1st ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 74.33  (5.99) 128.40  (23.44) 66.68  (25.01)
2nd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 75.53  (5.18) 146.34  (12.40) 99.15  (41.14)
3rd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 74.74  (6.38) 146.99  (15.44) 93.62  (32.01)
4th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 74.89  (7.04) 146.29  (14.18) 112.85  (42.17)
5th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 75.47  (6.66) 146.45  (12.83) 133.28  (24.46)
6th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) NA [1]   (NA) NA [2]   (NA) 127.83  (28.02)
1st ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 96.13  (14.07) 184.28  (37.04) 106.73  (36.05)
2nd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 98.29  (8.90) 208.64  (19.28) 126.94  (59.05)
3rd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 98.14  (10.16) 208.15  (19.35) 120.41  (43.85)
4th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 100.34  (7.82) 209.85  (18.94) 141.27  (53.89)
5th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 101.40  (5.50) 208.45  (20.40) 164.80  (51.32)
6th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) NA [1]   (NA) NA [2]   (NA) 169.31  (51.77)
1st ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 131.77  (24.28) 258.08  (47.10) 114.78  (45.40)
2nd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 140.31  (19.85) 279.59  (39.96) 141.03  (43.06)
3rd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 138.62  (17.13) 277.63  (42.97) 110.20  (67.33)
4th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 146.82  (16.34) 282.89  (33.87) 127.45  (55.50)
5th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 146.37  (14.43) 283.06  (37.54) 198.45  (77.99)
6th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) NA [1]   (NA) NA [2]   (NA) 175.21  (81.23)
1st ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 24.14  (23.30)
2nd ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 28.81  (24.00)
3rd ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 37.34  (21.91)
4th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 52.04  (24.45)
5th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 54.44  (16.57)
6th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 54.70  (23.15)
1st ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 18.12  (21.88)
2nd ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 39.87  (31.31)
3rd ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 52.03  (29.57)
4th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 57.79  (22.72)
5th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 57.73  (24.68)
6th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 55.23  (25.69)
1st ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 28.81  (35.64)
2nd ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 40.72  (35.24)
3rd ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 39.89  (37.63)
4th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 54.66  (44.31)
5th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 54.30  (30.86)
6th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 65.00  (50.28)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Group-A subjects did not test using the SnP.
[4]
Group-B subjects did not test using the SnP.
11.Primary Outcome
Title Information Transfer Rate (Percentage of Correctly Completed Commands)
Hide Description Computer randomly highlights one out of six or four commands and the subjects issue that particular command using the tongue drive system (TDS) and the sip-and-puff device (SnP). Subjects are given a time period (T). The time intervals for the TDS:(Group-A)2.0s,1.5s,1.0s,(Group-B &-C)1.0s,0.7s,0.5s,SnP:(Group-C)1.2s,1.0s,0.7s. The saturated results were observed from the second session during Group-A trials. Therefore, we reduced the time period from the Group-B trial. Moreover, the SnP device needs a certain time period to issue a command and we observed that the minimum possible time period was 0.7 seconds. At the end the percentage of correctly selected commands is calculated and fed into an equation along with the time given to the subjects for each selection.Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Percentage of correctly completed cmd(%)
1st ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 98.62  (2.61) 93.51  (1.24) 73.87  (11.72)
2nd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 99.12  (2.30) 98.15  (0.51) 83.70  (15.37)
3rd ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 98.75  (3.03) 98.73  (0.45) 83.93  (9.60)
4th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 98.75  (3.45) 98.08  (0.61) 90.95  (10.80)
5th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) 99.79  (1.58) 98.17  (0.54) 94.63  (6.60)
6th ses. using TDS (Grp A:T=2.0s, Grp B&C T=1.0s) NA [1]   (NA) NA [2]   (NA) 93.00  (7.64)
1st ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 97.50  (5.46) 93.18  (1.25) 96.92  (8.85)
2nd ses. using TDS (Grp A:T=1.5, Grp B&C T=0.7s) 98.33  (2.99) 98.06  (0.57) 82.54  (14.00)
3rd ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 98.20  (3.65) 97.99  (0.57) 78.70  (11.02)
4th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 98.97  (2.69) 98.24  (0.56) 85.00  (11.75)
5th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) 99.37  (1.73) 98.01  (0.63) 91.47  (7.93)
6th ses. using TDS (Grp A:T=1.5s, Grp B&C T=0.7s) NA [1]   (NA) NA [2]   (NA) 89.71  (11.71)
1st ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 94.61  (6.69) 93.67  (1.25) 69.34  (12.83)
2nd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 96.53  (4.94) 96.44  (0.99) 73.91  (8.11)
3rd ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 94.32  (3.99) 96.12  (1.05) 67.66  (16.01)
4th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 98.07  (4.04) 96.96  (0.77) 72.99  (13.34)
5th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) 98.07  (3.28) 96.87  (0.89) 84.87  (11.87)
6th ses. using TDS (Grp A:T=1.0s, Grp B&C T=0.5s) NA [1]   (NA) NA [2]   (NA) 78.81  (14.70)
1st ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 56.48  (22.92)
2nd ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 62.65  (19.53)
3rd ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 73.51  (15.05)
4th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 79.72  (13.96)
5th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 82.41  (9.05)
6th ses. using SnP (Grp C T=1.2s) NA [3]   (NA) NA [4]   (NA) 82.72  (10.57)
1st ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 56.48  (21.85)
2nd ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 62.65  (25.88)
3rd ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 75.89  (15.44)
4th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 80.00  (12.11)
5th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 78.40  (11.15)
6th ses. using SnP (Grp C T=1.0s) NA [3]   (NA) NA [4]   (NA) 73.81  (16.62)
1st ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 43.21  (26.15)
2nd ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 54.63  (26.49)
3rd ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 52.78  (24.40)
4th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 63.06  (28.17)
5th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 62.96  (21.72)
6th ses. using SnP (Grp C T=0.7s) NA [3]   (NA) NA [4]   (NA) 62.78  (26.15)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Group-A subjects did not test using the SnP.
[4]
Group-B subjects did not test using the SnP.
12.Primary Outcome
Title On-screen Maze Using TDS, Keypad, and SnP (Completion Time)
Hide Description

Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: seconds
first session using TDS 27.80  (18.77) 23.36  (9.87) 34.27  (13.25)
second session using TDS 16.61  (4.35) 17.13  (5.72) 28.71  (12.58)
third session using TDS 15.41  (3.45) 16.81  (12.28) 32.70  (21.24)
fourth session using TDS 15.04  (3.57) 13.03  (4.49) 25.93  (9.91)
fifth session using TDS 14.26  (2.77) 12.59  (3.41) 25.99  (15.27)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 19.47  (14.66)
first session using keypad 20.26  (4.21) 17.56  (6.24) NA [3]   (NA)
second session using keypad 16.76  (3.30) 13.14  (2.34) NA [3]   (NA)
third session using keypad 15.30  (2.54) 12.31  (2.08) NA [3]   (NA)
fourth session using keypad 14.65  (1.67) 11.76  (2.12) NA [3]   (NA)
fifth session using keypad 14.25  (1.42) 10.96  (1.99) NA [3]   (NA)
first session using SnP NA [4]   (NA) NA [5]   (NA) 49.86  (28.22)
second session using SnP NA [4]   (NA) NA [5]   (NA) 37.48  (18.15)
third session using SnP NA [4]   (NA) NA [5]   (NA) 33.49  (12.42)
fourth session using SnP NA [4]   (NA) NA [5]   (NA) 30.56  (10.08)
fifth session using SnP NA [4]   (NA) NA [5]   (NA) 30.65  (9.28)
sixth session using SnP NA [4]   (NA) NA [5]   (NA) 30.89  (10.33)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Group-A subjects did not test using the SnP.
[5]
Group-B subjects did not test using the SnP.
13.Primary Outcome
Title On-screen Maze Using TDS, Keypad, and SnP (Sum of Deviation / 1000)
Hide Description

Subjects were instructed to use four directional commands (Left, Right, Up, and Down) to move the mouse cursor using the tongue drive system (TDS), keypad, and the sip-and-puff device (SnP) as fast and accurately as possible on a maze. One out of eight maze patterns was randomly selected in each round. The performance measures were completion time (CT) from start to end and sum of deviation (SoD) from the track. SoD was calculated as the sum of all areas between the actual trajectory of the cursor when it was out of the track and the closest edge of the track divided by 1000.

Group-A and -B were scheduled for five consecutive TDS trials with intervals ranging from two to ten days. Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: pixel^2/1000
first session using TDS 30.05  (89.76) 23.59  (20.28) 64.86  (91.42)
second session using TDS 4.51  (4.08) 13.27  (20.28) 41.86  (41.83)
third session using TDS 4.17  (5.20) 13.91  (31.22) 59.19  (84.68)
fourth session using TDS 4.54  (5.18) 5.89  (13.05) 28.43  (24.97)
fifth session using TDS 1.80  (1.68) 4.27  (3.58) 29.05  (35.49)
sixth session using TDS NA [1]   (NA) NA [2]   (NA) 17.18  (29.84)
first session using keypad 1.88  (2.32) 4.03  (5.85) NA [3]   (NA)
second session using keypad 1.10  (1.48) 1.46  (1.82) NA [3]   (NA)
third session using keypad 0.60  (1.01) 1.08  (1.01) NA [3]   (NA)
fourth session using keypad 0.56  (0.66) 1.55  (1.40) NA [3]   (NA)
fifth session using keypad 0.39  (0.60) 1.16  (1.57) NA [3]   (NA)
first session using SnP NA [4]   (NA) NA [5]   (NA) 47.05  (104.05)
second session using SnP NA [4]   (NA) NA [5]   (NA) 20.26  (18.68)
third session using SnP NA [4]   (NA) NA [5]   (NA) 14.04  (11.87)
fourth session using SnP NA [4]   (NA) NA [5]   (NA) 12.19  (11.27)
fifth session using SnP NA [4]   (NA) NA [5]   (NA) 15.32  (19.02)
sixth session using SnP NA [4]   (NA) NA [5]   (NA) 11.17  (9.06)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Subjects with Spinal cord injury cannot use the keypad.
[4]
Group-A subjects did not test using the SnP.
[5]
Group-B subjects did not test using the SnP.
14.Primary Outcome
Title Driving a Wheelchair Using TDS vs SnP (Completion Time)
Hide Description

An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.

Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.

Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.

Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.

Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: seconds
first session using TDS (unlatched) 198.17  (34.01) 240.85  (81.77) 253.45  (70.11)
second session using TDS (unlatched) 169.21  (25.08) 194.93  (29.48) 219.46  (56.02)
third session using TDS (unlatched) 173.46  (30.27) 179.39  (29.80) 186.04  (18.25)
fourth session using TDS (unlatched) 170.00  (38.80) 179.74  (22.78) 183.70  (23.27)
fifth session using TDS (unlatched) 160.08  (18.22) 154.59  (23.52) 181.24  (27.39)
sixth session using TDS (unlatched) NA [1]   (NA) NA [2]   (NA) 170.76  (19.76)
first session using TDS (latched) 230.29  (48.45) 260.86  (84.97) 295.54  (151.08)
second session using TDS (latched) 192.46  (27.50) 210.22  (34.42) 264.78  (107.65)
third session using TDS (latched) 196.08  (35.78) 200.96  (39.60) 228.78  (101.65)
fourth session using TDS (latched) 181.42  (26.28) 193.75  (37.92) 217.63  (84.98)
fifth session using TDS (latched) 179.13  (23.22) 174.33  (34.15) 189.52  (19.68)
sixth session using TDS (latched) NA [1]   (NA) NA [2]   (NA) 179.37  (23.16)
first session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 234.97  (70.94)
second session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 213.28  (68.29)
third session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 196.24  (37.78)
fourth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 183.98  (36.22)
fifth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 191.43  (38.12)
sixth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 182.33  (21.34)
first session using TDS (semi-pro) 196.54  (16.46) 232.75  (66.47) 319.21  (112.70)
second session using TDS (semi-pro) 178.58  (14.42) 205.44  (32.64) 239.18  (62.38)
third session using TDS (semi-pro) 177.75  (11.87) 206.71  (30.35) 233.92  (60.00)
fourth session using TDS (semi-pro) 178.83  (14.70) 196.57  (28.86) 212.67  (44.90)
fifth session using TDS (semi-pro) 175.25  (17.07) 177.50  (37.44) 181.18  (27.27)
sixth session using TDS (semi-pro) NA [1]   (NA) NA [2]   (NA) 204.96  (35.23)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Group-A subjects did not test using the SnP.
[4]
Group-B subjects did not test using the SnP.
15.Primary Outcome
Title Driving a Wheelchair Using TDS vs SnP (Number of Navigation Errors)
Hide Description

An obstacle course will be laid out in an open space and the subjects drive an electric powered wheelchair using the tongue drive system (TDS) and the sip-and-puff device (SnP) to drive through the obstacle course. The operator measured the amount of time it takes for the subjects to begin and return back to the starting point and counts the number of collisions with the obstacles.

Unlatched and latched: utilize four TDS commands for forward, backward, left, and right motions.

Unlatched: hold their tongue to keep the PWC moving. Latched: (5 linear speed levels:Backward, Stop, Forward-1, Forward-2, and Forward-3) Issuing the forward or backward commands can increase or decrease the linear speed.

Semi-proportional: Quickly touching the left and right cheeks- forward or backward commands, sliding tongue over the lip- steer the PWC to the left or right.

Group-A&-B:5 consecutive TDS trials (intervals ranging from two to ten days) Group-C:computer and PWC within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11
Mean (Standard Deviation)
Unit of Measure: Navigation Errors
first session using TDS (unlatched) 2.67  (1.87) 8.44  (5.78) 8.76  (5.04)
second session using TDS (unlatched) 1.17  (1.30) 6.59  (6.76) 7.48  (4.85)
third session using TDS (unlatched) 1.08  (0.79) 3.96  (4.07) 5.82  (5.04)
fourth session using TDS (unlatched) 1.04  (1.46) 2.58  (2.26) 5.06  (4.03)
fifth session using TDS (unlatched) 0.75  (0.66) 2.22  (2.14) 2.97  (3.56)
sixth session using TDS (unlatched) NA [1]   (NA) NA [2]   (NA) 2.76  (3.46)
first session using TDS (latched) 3.50  (2.06) 7.80  (6.41) 10.61  (7.61)
second session using TDS (latched) 1.83  (1.13) 6.00  (2.77) 7.16  (5.00)
third session using TDS (latched) 1.38  (1.17) 4.79  (2.72) 7.03  (7.26)
fourth session using TDS (latched) 0.71  (1.06) 3.71  (3.16) 6.78  (9.51)
fifth session using TDS (latched) 0.96  (1.44) 3.70  (3.60) 3.06  (3.17)
sixth session using TDS (latched) NA [1]   (NA) NA [2]   (NA) 2.06  (2.26)
first session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 4.27  (3.06)
second session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 3.30  (2.01)
third session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 3.82  (2.92)
fourth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 2.39  (2.59)
fifth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 2.97  (2.30)
sixth session using SnP (latched) NA [3]   (NA) NA [4]   (NA) 2.61  (2.16)
first session using TDS (semi-pro) 2.08  (1.23) 2.52  (1.41) 7.81  (3.94)
second session using TDS (semi-pro) 1.00  (0.91) 2.92  (1.76) 5.79  (3.85)
third session using TDS (semi-pro) 0.96  (0.84) 2.00  (2.52) 5.15  (3.76)
fourth session using TDS (semi-pro) 1.00  (1.18) 1.89  (0.96) 3.64  (2.97)
fifth session using TDS (semi-pro) 0.88  (1.04) 1.71  (1.69) 2.97  (3.56)
sixth session using TDS (semi-pro) NA [1]   (NA) NA [2]   (NA) 3.12  (3.20)
[1]
Group-A subjects completed five-session trials.
[2]
Group-B subjects completed five-session trials.
[3]
Group-A subjects did not test using the SnP.
[4]
Group-B subjects did not test using the SnP.
16.Primary Outcome
Title Phone Dialing Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Hide Description

Randomly selected ten-digit target phone number was visually prompted on the top of the smartphone screen, and the subject entered the same number in the following line as quickly and as accurately as possible. If the wrong number was registered, then the subjects were allowed to delete the one by issuing the deleting command.At the end of the number entering, the subject needs to move the cursor at the green colored “CALL” button, in the middle of the bottom line, and it should be selected to complete the trial. The completion time and error rate were considered to evaluate the performance.

Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: seconds
first session using TDS 187.69  (66.09)
second session using TDS 109.11  (47.05)
third session using TDS 89.99  (21.08)
fourth session using TDS 88.37  (29.56)
fifth session using TDS 89.37  (27.05)
sixth session using TDS 81.87  (22.75)
17.Primary Outcome
Title Weight Shifting Using the Tongue Drive System (TDS) for People With Spinal Cord Injuries (Completion Time)
Hide Description

The TDS commands were designated to change the wheelchair mode from driving to tilting and to control the wheelchair angle. The completion time was from the initial mode change to the end of the weight shifting.

Testing sessions for Group-C were divided into computer access and PWC navigation within a week, over 6 weeks.

Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description:
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: seconds
first session using TDS 116.19  (42.69)
second session using TDS 74.82  (39.10)
third session using TDS 78.24  (29.93)
fourth session using TDS 75.52  (29.60)
fifth session using TDS 74.46  (32.67)
sixth session using TDS 71.35  (23.22)
18.Primary Outcome
Title Short Questionnaire at the End of Each Session Group-A&-B:5 Consecutive TDS Trials (Intervals Ranging From Two to Ten Days) Group-C:Computer and PWC Within a Week, Over 6 Weeks.
Hide Description Q1.How much thought was necessary to decide where to put your tongue to issue a specific command?1:A lot,5:A Little Q2.Was the speed of the movement of the cursor on the computer screen:1:Too slow,3:Just right,5:Too fast Q3.How difficult was pointing accurately at specific targets on the computer screen?1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1:Very difficult,5:Very easy Q4.Accurately guiding the powered wheelchair through the obstacle course was:1: Very difficult,5:Very easy (TDS:Q4-1.Unlatched,Q4-2.Latched,Q4-3.Semi-pro,SnP:Q4-4.Latched) Q5.Was the speed of the wheelchair:1:Too slow,5:Too fast Q6.Was the movement of the wheelchair:1:Very jerky,5:Very smooth Q7.Was TDS effective in dialing phone numbers:1:Completely ineffective,5:Very effective Q8.Was TDS effective in doing the weight shift:1:Completely ineffective,5:Very effective
Time Frame 24 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C): Computer Session Subjects With Spinal Cord Injury (Group-C): Wheelchair Session
Hide Arm/Group Description:
Able-bodied subjects who already have tongue piercing.
Able-bodied subjects who willing to receive a tongue piercing for this study.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
Overall Number of Participants Analyzed 14 9 11 11
Mean (Standard Deviation)
Unit of Measure: scores on a scale
Q1. (session1) 1: A lot, 5: A little 2.57  (1.16) 2.78  (0.67) 2.91  (1.38) 3.10  (1.29)
Q1. (session2) 1: A lot, 5: A little 4.07  (0.83) 3.44  (1.13) 3.90  (1.10) 3.91  (0.70)
Q1. (session3) 1: A lot, 5: A little 4.25  (0.87) 3.56  (1.01) 3.82  (0.87) 4.00  (1.10)
Q1. (session4) 1: A lot, 5: A little 4.50  (0.80) 3.63  (1.06) 3.91  (1.30) 3.73  (1.35)
Q1. (session5) 1: A lot, 5: A little 4.17  (0.96) 3.33  (1.00) 4.27  (0.90) 4.09  (1.83)
Q1. (session6) 1: A lot, 5: A little NA [1]   (NA) NA [2]   (NA) 4.36  (0.81) NA [3]   (NA)
Q2. (session1) 1: Too slow, 3: Just right, 5: Too 3.21  (0.43) 3.11  (0.78) 3.27  (0.47) NA [4]   (NA)
Q2. (session2) 1: Too slow, 3: Just right, 5: Too 3.07  (0.47) 3.22  (1.09) 0.34  (0.52) NA [4]   (NA)
Q2. (session3) 1: Too slow, 3: Just right, 5: Too 3.00  (0.43) 3.22  (1.30) 3.00  (0.89) NA [4]   (NA)
Q2. (session4) 1: Too slow, 3: Just right, 5: Too 3.00  (0.43) 3.13  (0.64) 3.27  (0.79) NA [4]   (NA)
Q2. (session5) 1: Too slow, 3: Just right, 5: Too 3.08  (0.49) 3.00  (0.71) 3.18  (0.75) NA [4]   (NA)
Q2. (session6) 1: Too slow, 3: Just right, 5: Too NA [1]   (NA) NA [2]   (NA) 3.18  (0.75) NA [4]   (NA)
Q3. (session1) 1: Very difficult, 5: Very easy 2.71  (0.73) 3.56  (0.88) 3.36  (1.12) NA [4]   (NA)
Q3. (session2) 1: Very difficult, 5: Very easy 3.43  (0.94) 2.89  (0.60) 3.90  (0.57) NA [4]   (NA)
Q3. (session3) 1: Very difficult, 5: Very easy 3.50  (0.80) 3.11  (0.78) 3.64  (0.81) NA [4]   (NA)
Q3. (session4) 1: Very difficult, 5: Very easy 3.92  (0.67) 3.75  (0.71) 3.91  (0.70) NA [4]   (NA)
Q3. (session5) 1: Very difficult, 5: Very easy 4.15  (0.69) 3.00  (0.71) 4.09  (0.83) NA [4]   (NA)
Q3. (session6) 1: Very difficult, 5: Very easy NA [1]   (NA) NA [2]   (NA) 4.27  (0.79) NA [4]   (NA)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-1) 3.43  (0.76) 3.22  (1.20) NA [5]   (NA) 4.10  (0.88)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-1) 3.93  (0.62) 4.11  (0.78) NA [5]   (NA) 4.00  (0.77)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-1) 3.75  (0.87) 3.44  (0.88) NA [5]   (NA) 3.64  (1.12)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-1) 4.25  (0.97) 3.50  (1.69) NA [5]   (NA) 3.73  (1.01)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-1) 4.07  (0.92) 3.67  (1.12) NA [5]   (NA) 3.82  (0.75)
Q5. (session1) 1: Too slow, 5: Too Fast 2.71  (0.47) 2.67  (0.87) NA [5]   (NA) 2.70  (0.67)
Q5. (session2) 1: Too slow, 5: Too Fast 2.29  (0.61) 2.44  (0.73) NA [5]   (NA) 2.64  (0.92)
Q5. (session3) 1: Too slow, 5: Too Fast 2.58  (0.67) 2.22  (0.67) NA [5]   (NA) 0.64  (0.81)
Q5. (session4) 1: Too slow, 5: Too Fast 2.50  (0.67) 2.25  (0.46) NA [5]   (NA) 2.55  (0.82)
Q5. (session5) 1: Too slow, 5: Too Fast 2.36  (0.63) 1.78  (0.67) NA [5]   (NA) 2.27  (1.01)
Q6. (session1) 1: Very jerky, 5: Very smooth 4.14  (0.77) 3.67  (1.12) NA [5]   (NA) 4.00  (0.94)
Q6. (session2) 1: Very jerky, 5: Very smooth 4.14  (0.86) 3.33  (0.71) NA [5]   (NA) 3.91  (1.14)
Q6. (session3) 1: Very jerky, 5: Very smooth 4.50  (0.80) 3.22  (0.97) NA [5]   (NA) 3.91  (1.04)
Q6. (session4) 1: Very jerky, 5: Very smooth 4.08  (1.08) 3.63  (0.92) NA [5]   (NA) 4.00  (1.10)
Q6. (session5) 1: Very jerky, 5: Very smooth 4.00  (1.11) 3.63  (0.92) NA [5]   (NA) 3.82  (1.08)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-2) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.20  (0.79)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-2) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.45  (1.13)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-2) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.91  (0.70)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-2) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.64  (1.36)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-2) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.91  (0.83)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-3) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.40  (1.43)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-3) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.73  (1.27)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-3) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 4.00  (0.89)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-3) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 4.00  (1.00)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-3) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 3.64  (0.92)
Q4.(ses1)1:Very difficult,5:Very easy(GrpC:Q4-4) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 2.70  (0.67)
Q4.(ses2)1:Very difficult,5:Very easy(GrpC:Q4-4) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 2.64  (0.92)
Q4.(ses3)1:Very difficult,5:Very easy(GrpC:Q4-4) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 2.64  (0.81)
Q4.(ses4)1:Very difficult,5:Very easy(GrpC:Q4-4) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 2.55  (0.82)
Q4.(ses5)1:Very difficult,5:Very easy(GrpC:Q4-4) NA [6]   (NA) NA [7]   (NA) NA [5]   (NA) 2.27  (1.01)
Q7.(ses1)1:Completely ineffective,5:Very effective NA [8]   (NA) NA [9]   (NA) NA [10]   (NA) 3.22  (1.86)
Q7.(ses2)1:Completely ineffective,5:Very effective NA [8]   (NA) NA [9]   (NA) NA [10]   (NA) 4.00  (1.41)
Q7.(ses3)1:Completely ineffective,5:Very effective NA [8]   (NA) NA [9]   (NA) NA [10]   (NA) 4.10  (1.37)
Q7.(ses4)1:Completely ineffective,5:Very effective NA [8]   (NA) NA [9]   (NA) NA [10]   (NA) 4.40  (1.07)
Q7.(ses5)1:Completely ineffective,5:Very effective NA [8]   (NA) NA [9]   (NA) NA [10]   (NA) 4.80  (0.63)
Q8.(ses1)1:Completely ineffective,5:Very effective NA [11]   (NA) NA [12]   (NA) NA [10]   (NA) 3.71  (1.70)
Q8.(ses2)1:Completely ineffective,5:Very effective NA [11]   (NA) NA [12]   (NA) NA [10]   (NA) 4.60  (0.97)
Q8.(ses3)1:Completely ineffective,5:Very effective NA [11]   (NA) NA [12]   (NA) NA [10]   (NA) 4.70  (0.67)
Q8.(ses4)1:Completely ineffective,5:Very effective NA [11]   (NA) NA [12]   (NA) NA [10]   (NA) 4.70  (0.67)
Q8.(ses5)1:Completely ineffective,5:Very effective NA [11]   (NA) NA [12]   (NA) NA [10]   (NA) 4.70  (0.67)
[1]
Group-A subjects completed 5-session trials.
[2]
Group-B subjects completed 5-session trials.
[3]
Group-C subjects were asked about wheelchair related questionnaire only for 5-session trials.
[4]
This questionnaire does not contain the computer related questions.
[5]
This questionnaire does not contain the PWC related questions.
[6]
This question was not separately asked for Group-A PWC session. (Check Q4)
[7]
This question was not separately asked for Group-B PWC session. (Check Q4)
[8]
Group-A subjects did not have phone dialing task.
[9]
Group-B subjects did not have phone dialing task.
[10]
This questionnaire does not contain the smartphone related questions.
[11]
Group-A subjects did not have weight shifting task.
[12]
Group-B subjects did not have weight shifting task.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Hide Arm/Group Description Able-bodied subjects who already have tongue piercing. Able-bodied subjects who willing to receive a tongue piercing for this study. Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
All-Cause Mortality
Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/24 (0.00%)   0/21 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Able-bodied Subject With Tongue Piercing (Group-A) Able-bodied Subject Without Tongue Piercing (Group-B) Subjects With Spinal Cord Injury (Group-C)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/16 (0.00%)   0/24 (0.00%)   0/21 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Maysam Ghovanloo
Organization: Georgia Institute of Technology
Phone: 404-385-7048
Responsible Party: Maysam Ghovanloo, Georgia Institute of Technology
ClinicalTrials.gov Identifier: NCT01124292     History of Changes
Other Study ID Numbers: H09240
1RC1EB010915-01 ( U.S. NIH Grant/Contract )
First Submitted: May 10, 2010
First Posted: May 17, 2010
Results First Submitted: May 2, 2013
Results First Posted: September 10, 2013
Last Update Posted: September 18, 2013