Trial Outcomes & Findings for Locomotor Training in Persons With Multiple Sclerosis (NCT NCT00607126)
NCT ID: NCT00607126
Last Updated: 2016-08-15
Results Overview
This is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
at beginning,mid point, end and 12 weeks after intervention
Results posted on
2016-08-15
Participant Flow
Prospective subjects were recruited from the MS clinic population of the UCLA Dep't/ of Neurology and from the general MS population in Los Angeles between 2007-2009. Recruitment flyers were approved by the UCLA Institutional Review board.
38 subjects were consented and randomized; two subjects volitionally dropped out before participating in the study; this accounts for the discrepancy..
Participant milestones
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
19
|
|
Overall Study
COMPLETED
|
17
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Locomotor Training in Persons With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
n=17 Participants
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
n=19 Participants
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
Total
n=36 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
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 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
|
9 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
EDSS
|
6.5 units on a scale
n=5 Participants
|
6.0 units on a scale
n=7 Participants
|
6.3 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: at beginning,mid point, end and 12 weeks after interventionThis is the time needed for participant to walk 25 feet. Participant walks on a level surface. the walk from start to finish is timed with a stop watch three measures are done and the average value is entered.
Outcome measures
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
n=17 Participants
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
n=19 Participants
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
|---|---|---|
|
Walking Speed as Assessed by 25' Timed Walk
25"TW baseline
|
22.7 seconds
Standard Deviation 17.6
|
10.6 seconds
Standard Deviation 4.9
|
|
Walking Speed as Assessed by 25' Timed Walk
25'TW midpoint
|
23.9 seconds
Standard Deviation 20.9
|
9.8 seconds
Standard Deviation 4.3
|
|
Walking Speed as Assessed by 25' Timed Walk
25'TW end point
|
19.4 seconds
Standard Deviation 15.2
|
9.6 seconds
Standard Deviation 3.7
|
|
Walking Speed as Assessed by 25' Timed Walk
25'TW post
|
21.7 seconds
Standard Deviation 16.7
|
10.5 seconds
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: baseline, mid point, end and 12 weeks after trainingdistance assessed by 6 minute walk test
Outcome measures
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
n=17 Participants
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
n=19 Participants
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
|---|---|---|
|
Distance
6 min walk baseline
|
367 feet
Standard Deviation 241
|
753 feet
Standard Deviation 232.3
|
|
Distance
6 min walk midpoint
|
474 feet
Standard Deviation 354
|
813 feet
Standard Deviation 253.8
|
|
Distance
6 minute walk end point
|
436 feet
Standard Deviation 288
|
769 feet
Standard Deviation 261.9
|
|
Distance
6 minute walk post
|
457 feet
Standard Deviation 300.5
|
742 feet
Standard Deviation 248.2
|
SECONDARY outcome
Timeframe: baseline, mid, completetion, 3 months postfatigue assessed by modified fatigue impact scale. This is a 21 item questionnaire which has a range from 0-84. Higher scores indicate more impact of fatigue on physical and cognitive functioning.
Outcome measures
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
n=17 Participants
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
n=19 Participants
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
|---|---|---|
|
Fatigue
MFIS baseline
|
34.1 units on a scale
Standard Deviation 14.1
|
37.7 units on a scale
Standard Deviation 15.6
|
|
Fatigue
MFIS mid point
|
26.7 units on a scale
Standard Deviation 13.7
|
29.4 units on a scale
Standard Deviation 15.0
|
|
Fatigue
MFIS end point
|
26.8 units on a scale
Standard Deviation 16.6
|
29.9 units on a scale
Standard Deviation 17.7
|
|
Fatigue
MFIS post
|
27.4 units on a scale
Standard Deviation 19.8
|
35.3 units on a scale
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: baseline, mid, completion, 3 months post trainingCognitive measure of attention and information processing speed. Score goes from 0-60 with higher number indicating better performance. Scores are expressed as mean chamge rfom baseline; negative numbers indicate worse performance
Outcome measures
| Measure |
Lokomat Training Using Body Weight Support on a Treadmill
n=17 Participants
Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
|
Resistive Training
n=19 Participants
resistive training using weights and therabands
This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session.
|
|---|---|---|
|
PASAT
PASAT baseline
|
48.2 units on a scale
Standard Error 5.1
|
46.8 units on a scale
Standard Error 3.8
|
|
PASAT
PASAT Mid point
|
0.06 units on a scale
Standard Error 1.17
|
0.42 units on a scale
Standard Error 1.03
|
|
PASAT
PASAT end point
|
1.3 units on a scale
Standard Error 1.13
|
0.58 units on a scale
Standard Error 1.03
|
|
PASAT
PASAT post
|
1.90 units on a scale
Standard Error 1.13
|
-0.91 units on a scale
Standard Error 1.13
|
Adverse Events
Lokomat Training Using Body Weight Support on a Treadmill
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Resistive Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Barbara Giesser,MD
DAvdi Geffen School of Medicine at UCLA
Phone: 310-825-7313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place