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Multimodal Exercises to Improve Leg Function After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT01740128
Recruitment Status : Completed
First Posted : December 4, 2012
Results First Posted : February 26, 2018
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Spinal Cord Injuries
Paraplegia
Paraparesis
Interventions Device: Robotic body weight supported treadmill training
Other: Harness-supported multimodal balance training
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Multimodal Then Treadmill Training Treadmill Then Multimodal Training
Hide Arm/Group Description

Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Participants will undergo body weight supported treadmill training using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Period Title: Overall Study
Started 10 11
Completed 4 4
Not Completed 6 7
Reason Not Completed
Pregnancy             0             1
Protocol Violation             1             2
Lost to Follow-up             2             2
Withdrawal by Subject             1             0
Insufficient protocol compliance             2             2
Arm/Group Title Multimodal Then Treadmill Training Treadmill Then Multimodal Training Total
Hide Arm/Group Description

Participants will undergo harness-supported multimodal balance training exercises while simultaneously performing skilled hand exercises. Following a washout period of at least 6 weeks, Participants will undergo body weight supported treadmill training using the Lokomat apparatus.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus. Following a washout period of at least 6 weeks, Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 10 11 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
10
 100.0%
11
 100.0%
21
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
Female
3
  30.0%
2
  18.2%
5
  23.8%
Male
7
  70.0%
9
  81.8%
16
  76.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 11 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   9.1%
1
   4.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  30.0%
6
  54.5%
9
  42.9%
White
6
  60.0%
3
  27.3%
9
  42.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
1
   9.1%
2
   9.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 11 participants 21 participants
10
 100.0%
11
 100.0%
21
 100.0%
1.Primary Outcome
Title Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.
Hide Description Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only two participants in the study had consistent MEPs at baseline.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 1 1
Measure Type: Number
Unit of Measure: Amplitude percentage of Mmax
-1.75 -2.01
2.Secondary Outcome
Title Change From Baseline in ISNCSCI Lower Extremity Motor Score.
Hide Description Change between baseline and Evaluation #2 in lower extremity motor score derived from the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). Range of scores 0-50, higher is better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
One subject in multimodal group failed to appear for post-intervention testing for this outcome.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.11  (4.81) -0.30  (4.32)
3.Secondary Outcome
Title Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.
Hide Description Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.10  (0.32) 0.00  (0.00)
4.Secondary Outcome
Title Change in Leg Spasticity on Modified Ashworth Scale
Hide Description Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 4 9
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.13  (0.25) -0.39  (0.89)
5.Secondary Outcome
Title Change in Gait Speed on 10-meter Walk Test.
Hide Description Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Insufficient number of participants able to walk at baseline.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 1 3
Mean (Standard Deviation)
Unit of Measure: meters per second
.04  (0) 0.12  (0.132)
6.Secondary Outcome
Title Change From Baseline in Walking Index for Spinal Cord Injury II (WISCI II) Scale.
Hide Description Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.
Hide Description Change between baseline and Evaluation #2 in steps taken during 10-second step test.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Low number of participants able to perform seated steps at baseline.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 4 4
Mean (Standard Error)
Unit of Measure: steps
2.83  (1.14) -1.08  (1.03)
8.Secondary Outcome
Title Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).
Hide Description Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 9 7
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.89  (2.76) -0.93  (3.00)
9.Secondary Outcome
Title Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.
Hide Description Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.
Time Frame Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 10 9
Mean (Standard Error)
Unit of Measure: Percentage of perfect path to target
1.93  (3.42) 8.42  (4.02)
10.Secondary Outcome
Title Change From Baseline in Soleus H-reflex Facilitation.
Hide Description Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.
Time Frame Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 7 8
Mean (Standard Error)
Unit of Measure: percentage of control reflex size
6.63  (6.25) -5.20  (3.35)
11.Secondary Outcome
Title Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)
Hide Description Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.
Time Frame Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description:

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Overall Number of Participants Analyzed 7 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.14  (11.44) -0.67  (0.82)
Time Frame Approx. 6 months or until completion of study participation.
Adverse Event Reporting Description No serious adverse events. Several minor skin abrasions.
 
Arm/Group Title Multimodal Training Treadmill Training
Hide Arm/Group Description

Participants will undergo harness-supported balance training exercises while simultaneously performing skilled hand exercises.

Multimodal training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

Robotic body weight supported treadmill training will be applied using the Lokomat apparatus.

Robotic body weight supported treadmill training: 30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.

All-Cause Mortality
Multimodal Training Treadmill Training
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Multimodal Training Treadmill Training
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/11 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Multimodal Training Treadmill Training
Affected / at Risk (%) Affected / at Risk (%)
Total   1/10 (10.00%)   3/11 (27.27%) 
Skin and subcutaneous tissue disorders     
skin abrasion *  1/10 (10.00%)  3/11 (27.27%) 
*
Indicates events were collected by non-systematic assessment
Smaller than expected enrollment, high dropout rate.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Noam Y. Harel, MD, PhD
Organization: James J. Peters VAMC
Phone: 718-584-9000 ext 1742
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01740128     History of Changes
Other Study ID Numbers: B0881-W
5IK2RX000881-03 ( U.S. NIH Grant/Contract )
01407 ( Other Identifier: Bronx VA Medical Center )
SPU-11-077 ( Other Identifier: Bronx VA Medical Center )
First Submitted: November 30, 2012
First Posted: December 4, 2012
Results First Submitted: November 16, 2017
Results First Posted: February 26, 2018
Last Update Posted: February 26, 2018