Trial Outcomes & Findings for Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury (NCT NCT01087918)
NCT ID: NCT01087918
Last Updated: 2012-10-29
Results Overview
The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed \[m/s\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
COMPLETED
PHASE1/PHASE2
9 participants
Baseline, after intervention (4 weeks)
2012-10-29
Participant Flow
Participant recruitment from a spinal cord injury hospital in Zurich, Switzerland between March 2009 and March 2011.
97 possible participants recruited; 9 participated, 88 excluded (12 did not meet inclusion criteria and 76 refused participation)
Participant milestones
| Measure |
Robot-assisted Gait Training First, Then Strength Training
16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
|
Strength Training First, Then Robot-assisted Gait Training
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
4
|
|
Overall Study
COMPLETED
|
5
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lokomat Versus Strength Training in Chronic Incomplete Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Robot-assisted Gait Training First, Then Strength Training
n=5 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
|
Strength Training First, Then Robot-assisted Gait Training
n=4 Participants
16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
|
Total
n=9 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
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age Continuous
|
58.8 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 12.8 • n=7 Participants
|
59.0 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Weight
|
80.8 kg
STANDARD_DEVIATION 15.9 • n=5 Participants
|
70.0 kg
STANDARD_DEVIATION 17.1 • n=7 Participants
|
76.0 kg
STANDARD_DEVIATION 16.4 • n=5 Participants
|
|
Height
|
1.76 m
STANDARD_DEVIATION 0.077 • n=5 Participants
|
1.67 m
STANDARD_DEVIATION 0.075 • n=7 Participants
|
1.72 m
STANDARD_DEVIATION 0.086 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, after intervention (4 weeks)The 10 meter walk test assesses the time required to walk 10 meters at the patient's preferred speed (in seconds). Results were converted to walking speed \[m/s\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
10 Meter Walking at Preferred Speed
|
0.04 meters per second
Standard Deviation 0.10
|
0.06 meters per second
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: Baseline, after intervention (4 weeks)The 10 meter walking speed assesses the time needed to walk 10 meters at maximal speed (in seconds). Results were converted to walking speed \[m/s\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
10 Meter Walking at Maximal Speed
|
0.01 meters per second
Standard Deviation 0.18
|
0.14 meters per second
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)The WISCI II describes whether a patients requires waling aids, braces or personal assistance to walk 10 meters. It is an ordinal scale varying from 0 (= not able to walk 10 meters) to 20 (= able to walk 10 meters with no walking aids, braces or personal assistance). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Walking Index for Spinal Cord Injury II
|
0.78 units on a scale
Standard Deviation 1.6
|
0.33 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)The Berg Balance Scale is a performance-based measure of balance. It is scored from 0 (= failed all items) to 56 points (= scored maximally in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Berg Balance Scale
|
1.11 units on a scale
Standard Deviation 1.90
|
2.78 units on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)The SCIM assesses functional independence after spinal cord injury. It is scored from 0 (= total dependence in everyday life) to 100 points (= complete independence in everyday life). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Spinal Cord Independence Measure III
|
0.78 units on a scale
Standard Deviation 2.17
|
1.33 units on a scale
Standard Deviation 1.87
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)Motor evoked potential was elicited by transcranial magnetic stimulation. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Mean Latency of the Averaged Motor Evoked Potentials of the Right and the Left M. Tibialis
|
0.43 milliseconds
Standard Deviation 1.42
|
0.42 milliseconds
Standard Deviation 1.38
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)With the manual muscle test, we examined strength of the lower extremities. Five key muscles on each side are evaluated from 0 (= total paralysis) to 5 (= normal strength). Values for left and right were then averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Manual Muscle Test of the Lower Extremity
|
0.67 units on a scale
Standard Deviation 1.12
|
1.00 units on a scale
Standard Deviation 1.00
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)Population: Only 8 patients participated at pain assessments as 1 patient did not suffer from pain.
Pain was scored on a visual analogue scale from 0 (= no pain) to 100 (= maximal pain). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=8 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=8 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Pain on a Visual Analogue Scale
|
-4.5 units on a scale
Standard Deviation 2.2
|
-6.8 units on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)We measured choice stepping response time on a plate in a standing position. Participant had to move their feet to flashing LEDs as fast as possible. Valid values of the right and the left foot were averaged. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Response Time of the Lower Extremities
|
-1.8 milliseconds
Standard Deviation 63.0
|
-17.6 milliseconds
Standard Deviation 66.4
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)The Falls Efficacy Scale evaluates fear of falling in everyday life situations. It is scored from 16 (= no fear at all) to 64 points (= maximal fear in all items). Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Negative values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Falls Efficacy Scale
|
0.17 units on a scale
Standard Deviation 4.99
|
0.56 units on a scale
Standard Deviation 2.88
|
SECONDARY outcome
Timeframe: Baseline, after intervention (4 weeks)The Figure of Eight Test is a 10m Walk Test in the shape of a figure of eight. Time for completion of one lap is recorded and converted to \[m/s\]. Displayed are values after each intervention (RAGT or strength training) minus value at baseline. Positive values denote improvements.
Outcome measures
| Measure |
Robot-assisted Gait Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
Strength Training
n=9 Participants
16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
|
|---|---|---|
|
Figure of Eight Test
|
0.004 meters per second
Standard Deviation 0.04
|
0.04 meters per second
Standard Deviation 0.09
|
Adverse Events
Robot-assisted Gait Training First, Then Strength Training
Strength Training First, Then Robot-assisted Gait Training
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place