Trial Outcomes & Findings for Multimodal Exercises to Improve Leg Function After Spinal Cord Injury (NCT NCT01740128)
NCT ID: NCT01740128
Last Updated: 2018-02-26
Results Overview
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)
Results posted on
2018-02-26
Participant Flow
Participant milestones
| Measure |
Multimodal Then Treadmill Training
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.
|
Treadmill Then Multimodal Training
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
11
|
|
Overall Study
COMPLETED
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
6
|
7
|
Reasons for withdrawal
| Measure |
Multimodal Then Treadmill Training
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.
|
Treadmill Then Multimodal Training
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.
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Insufficient protocol compliance
|
2
|
2
|
Baseline Characteristics
Multimodal Exercises to Improve Leg Function After Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Multimodal Then Treadmill Training
n=10 Participants
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.
|
Treadmill Then Multimodal Training
n=11 Participants
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
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Only two participants in the study had consistent MEPs at baseline.
Change between baseline and Evaluation #2 in motor evoked potential area in the tibialis anterior muscle.
Outcome measures
| Measure |
Multimodal Training
n=1 Participants
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.
|
Treadmill Training
n=1 Participants
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.
|
|---|---|---|
|
Change in Motor Evoked Potential (MEP) Amplitude in the Tibialis Anterior Muscle at the End of Training.
|
-1.75 Amplitude percentage of Mmax
|
-2.01 Amplitude percentage of Mmax
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: One subject in multimodal group failed to appear for post-intervention testing for this outcome.
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.
Outcome measures
| Measure |
Multimodal Training
n=9 Participants
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.
|
Treadmill Training
n=10 Participants
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.
|
|---|---|---|
|
Change From Baseline in ISNCSCI Lower Extremity Motor Score.
|
0.11 units on a scale
Standard Deviation 4.81
|
-0.30 units on a scale
Standard Deviation 4.32
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing
Change between baseline and Evaluation #2 in Berg sitting unsupported subscore. Range 0-4, higher better.
Outcome measures
| Measure |
Multimodal Training
n=10 Participants
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.
|
Treadmill Training
n=8 Participants
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.
|
|---|---|---|
|
Change From Baseline in Berg Balance Scale Sitting With Back Unsupported Score.
|
0.10 units on a scale
Standard Deviation 0.32
|
0.00 units on a scale
Standard Deviation 0.00
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Change between baseline and Evaluation #2 in modified Ashworth Scale. 0-4 score, lower is better.
Outcome measures
| Measure |
Multimodal Training
n=4 Participants
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.
|
Treadmill Training
n=9 Participants
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.
|
|---|---|---|
|
Change in Leg Spasticity on Modified Ashworth Scale
|
0.13 units on a scale
Standard Deviation 0.25
|
-0.39 units on a scale
Standard Deviation 0.89
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Insufficient number of participants able to walk at baseline.
Change between baseline and Evaluation #2 in gait speed during 10-meter walk test.
Outcome measures
| Measure |
Multimodal Training
n=1 Participants
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.
|
Treadmill Training
n=3 Participants
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.
|
|---|---|---|
|
Change in Gait Speed on 10-meter Walk Test.
|
.04 meters per second
Standard Deviation 0
|
0.12 meters per second
Standard Deviation 0.132
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Insufficient number of participants able to walk at baseline. Measure not recorded by Investigating team.
Change between baseline and Evaluation #2 in WISCI II score. Scores range 0-20, higher is better.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Low number of participants able to perform seated steps at baseline.
Change between baseline and Evaluation #2 in steps taken during 10-second step test.
Outcome measures
| Measure |
Multimodal Training
n=4 Participants
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.
|
Treadmill Training
n=4 Participants
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.
|
|---|---|---|
|
Change From Baseline in Total Number of Steps Taken by Both Feet During Seated 10-second Step Test.
|
2.83 steps
Standard Error 1.14
|
-1.08 steps
Standard Error 1.03
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Change between baseline and Evaluation #2 in McGill Pain Questionnaire (Subjective Domain). Total scale 0-45, lower is better.
Outcome measures
| Measure |
Multimodal Training
n=9 Participants
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.
|
Treadmill Training
n=7 Participants
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.
|
|---|---|---|
|
Change in Subjective Pain as Determined by McGill Pain Questionnaire (Short Form).
|
0.89 units on a scale
Standard Deviation 2.76
|
-0.93 units on a scale
Standard Deviation 3.00
|
SECONDARY outcome
Timeframe: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing.
Seated posturography performed using the "Limits of Stability" module of the Smart EquiTest apparatus (Neurocom) while seated. Directional Control measure.
Outcome measures
| Measure |
Multimodal Training
n=10 Participants
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.
|
Treadmill Training
n=9 Participants
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.
|
|---|---|---|
|
Change From Baseline in Endpoint Excursion and Directional Control Parameters Achieved During Seated Limits of Stability Testing.
|
1.93 Percentage of perfect path to target
Standard Error 3.42
|
8.42 Percentage of perfect path to target
Standard Error 4.02
|
SECONDARY outcome
Timeframe: Time Frame: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing, and due to lack of soleus H-reflex in several subjects.
Change between baseline and Evaluation #2 in soleus H-reflex facilitation by transcranial magnetic stimulation (TMS). Short-interval 0-20ms.
Outcome measures
| Measure |
Multimodal Training
n=7 Participants
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.
|
Treadmill Training
n=8 Participants
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.
|
|---|---|---|
|
Change From Baseline in Soleus H-reflex Facilitation.
|
6.63 percentage of control reflex size
Standard Error 6.25
|
-5.20 percentage of control reflex size
Standard Error 3.35
|
SECONDARY outcome
Timeframe: Eval #1 at baseline; Eval #2 at end of training (48 sessions, average 3-4 months)Population: Incomplete analysis due to dropouts before post-testing, and due to incomplete outcome assessment by Investigating team.
Change between baseline and Evaluation #2 in SCI-SET score. Range of scores -105 to +105. Higher is better.
Outcome measures
| Measure |
Multimodal Training
n=7 Participants
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.
|
Treadmill Training
n=6 Participants
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.
|
|---|---|---|
|
Changes From Baseline in Survey: Spinal Cord Injury - Spasticity Evaluation Tool (SCI-SET)
|
2.14 units on a scale
Standard Deviation 11.44
|
-0.67 units on a scale
Standard Deviation 0.82
|
Adverse Events
Multimodal Training
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Treadmill Training
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Multimodal Training
n=10 participants at risk
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.
|
Treadmill Training
n=11 participants at risk
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.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
skin abrasion
|
10.0%
1/10 • Approx. 6 months or until completion of study participation.
No serious adverse events. Several minor skin abrasions.
|
27.3%
3/11 • Approx. 6 months or until completion of study participation.
No serious adverse events. Several minor skin abrasions.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place