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Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

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ClinicalTrials.gov Identifier: NCT03011099
Recruitment Status : Completed
First Posted : January 5, 2017
Results First Posted : April 3, 2018
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
Matthew Edward Davis, The University of Texas Health Science Center, Houston

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Spinal Cord Injuries
Interventions Device: Robotic exoskeleton training
Other: Conventional physical therapy
Enrollment 12
Recruitment Details  
Pre-assignment Details One participant dropped out of the study after signing the consent before randomization.
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
Period Title: Overall Study
Started 6 5
Completed 6 3
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy Total
Hide Arm/Group Description During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise. During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period. Total of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
3
 100.0%
8
  88.9%
>=65 years
1
  16.7%
0
   0.0%
1
  11.1%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
2
  33.3%
1
  33.3%
3
  33.3%
Male
4
  66.7%
2
  66.7%
6
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 9 participants
6 3 9
1.Primary Outcome
Title Change in Over Ground Gait Speed as Assessed by the 10 Meter Walk Test
Hide Description The 10 Meter Walk Test assesses the time taken to walk 10 meters.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: seconds
-6.815  (9.58) -0.5  (4.02)
2.Primary Outcome
Title Change in Walking Endurance as Assessed by the 6 Minute Walk Test
Hide Description The 6 Minute Walk Test assesses the distance walked in 6 minutes.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: feet
34.3833  (42.83) 25.3  (25.96)
3.Primary Outcome
Title Change in Dynamic Mobility Assessment as Determined by the Timed Up and Go Test
Hide Description The Timed Up and Go test assessed the time it takes to stand from a sitting position, complete a 3 meter walk, and then return to sitting.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: Second
-10.575  (17.31) -1.59  (0.44)
4.Primary Outcome
Title Change in Muscle Activity as Assessed by Surface Electromyography (EMG)
Hide Description Surface EMG sensors will be placed on the skin of subjects’ lower extremities and trunk to measure muscle activity. Only one participant data was analyzed. Emg was recorded from the soleus, gastrocnemius, tibialis anterior, rectus femoris, vastus medialis, bicep femoris and semitendinosus muscles. The outcome measure is the %age change between the baseline and 4 week assessments. Negative values denotes decrease in muscle activity at 4 week compared to baseline.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was later added to the protocol and hence data was collected from one participant only.
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 1 0
Measure Type: Number
Unit of Measure: percentage of muscle activity change
Change in soleus activity -44
Change in gastrocnemius activity -37
Change in tibialis anterior activity 57
Change in Rectus Femoris activity 12
Change in Vastus Medialis activity -18
Change in Bicep Femoris activity 33
Change in Semitendinosus activity 32
5.Primary Outcome
Title Change in Energy Expenditure During Walking as Assessed by Oxygen Cost
Hide Description Oxygen cost will be calculated from oxygen consumption as the product of gait speed and body weight.20 Oxygen consumption will be calculated on a breath-by-breath basis measured by a portable metabolic system (Cosmed K4b2).
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The metabolic expenditure was only measured for two subjects who completed the Robotic exoskeleton training at the end of the study. The equipment to use metabolic expenditure was not available at that time of enrollment of the population at the beginning of the study. Therefore data was only collected once the equipment became operational.
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 2 0
Mean (Standard Deviation)
Unit of Measure: ml/min/kg
-0.84  (0.56)
6.Secondary Outcome
Title Change in Gait Characteristics as Assessed by the GAITRite Walkway (Cadence)
Hide Description Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. Cadence is measured as steps/min. Change in cadence is reported as difference between baseline and post assessment.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: steps/min
0.12  (0.17) 0.08  (0.11)
7.Secondary Outcome
Title Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Length)
Hide Description Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The change in step length between baseline and post assessment is reported. Negative value denotes decrease in step length.
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: cm
0.04  (0.11) -0.03  (0.08)
8.Secondary Outcome
Title Change in Gait Characteristics as Assessed by the GAITRite Walkway (Step Time)
Hide Description Gait quality will be measured with the GAITRite Walkway which can quantify step cadence, step length, step time, double support time, and symmetry. The outcome measure is the difference in step time between pre and post assessment. Negative value denotes decrease in step time (implying faster step time at post).
Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: seconds
-0.09  (0.13) -0.02  (0.11)
9.Secondary Outcome
Title Change in Lower Extremity Strength as Assessed by American Spinal Injury Association (ASIA) Lower Extremity Motor Score (LEMS)
Hide Description

The ASIA (American Spinal Injury Association) assessment protocol consists of two sensory examinations, a motor examination and a classification framework (the impairment scale) to quantify the severity of the spinal cord injury. The scale informs about the functionality of the patient. The range of scores is 0 to 5, and high values represent better outcome. Following is the description of the range:

0 = total paralysis

  1. = palpable or visible contraction
  2. = active movement, full range of motion (ROM) with gravity eliminated
  3. = active movement, full ROM against gravity
  4. = active movement, full ROM against gravity and moderate resistance in a muscle specific position
  5. = (normal) active movement, full ROM against gravity and full resistance in a functional muscle position expected from an otherwise unimpaired person

We report the difference between baseline and 4week assessments. Negative value denotes decrease at post assessment.

Time Frame baseline, week 4
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 3
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.42  (2.15) -0.17  (0.41)
10.Secondary Outcome
Title Exoskeleton User Feedback as Assessed by a Questionnaire
Hide Description A questionnaire will be administered to allow participants to provide feedback regarding their experiences during training sessions with the exoskeleton. The units on a scale was used to measure the feedback. The range of the scale was 1-5. '1' refers to very satisfied and '5' refers to very dissatisfied. '1' refers to a better outcome.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
This measure was only recorded from the participants in the robotic exoskeleton training group. This outcome was mainly related to the feedback of the participants after using the exoskeleton at the end of the training.
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description:
Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes
Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
Overall Number of Participants Analyzed 6 0
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.83  (0.75)
Time Frame Adverse event data were collected for each participant during their participation in the study. the study protocol was 1 month long.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Robotic Exoskeleton Training Conventional Physical Therapy
Hide Arm/Group Description Robotic exoskeleton training: During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes Conventional physical therapy: During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training
All-Cause Mortality
Robotic Exoskeleton Training Conventional Physical Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)      0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Robotic Exoskeleton Training Conventional Physical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Robotic Exoskeleton Training Conventional Physical Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/3 (0.00%)    
Musculoskeletal and connective tissue disorders     
swelling and pain in foot  1/6 (16.67%)  1 0/3 (0.00%)  0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chang, Shuo-Hsiu, PT, PhD
Organization: UT health PM&R
Phone: 713-799-7016
EMail: Shuo-Hsiu.Chang@uth.tmc.edu
Layout table for additonal information
Responsible Party: Matthew Edward Davis, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03011099     History of Changes
Other Study ID Numbers: HSC-MS-13-0536
First Submitted: January 3, 2017
First Posted: January 5, 2017
Results First Submitted: April 22, 2017
Results First Posted: April 3, 2018
Last Update Posted: April 3, 2018