A Phase 1/2 interventional study of Lokomat and resistive training in Multiple Sclerosis, sponsored by University of California, Los Angeles. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-15.
Sponsored by University of California, Los Angeles · Phase 1/2, Interventional, and Treatment
Locomotor training is a new exercise modality that emphasizes task specificity to promote learning and neural plasticity. It has been reported to improve walking in patients with stroke, spinal cord injury and cerebral palsy. In this study, 40 patients with impaired ambulation due to Multiple Sclerosis will be randomized to receive 36 sessions of either locomotor training or an standard resistive exercise intervention.The locomotor training will be accomplished via a robotic device, the Lokomat, which will move the patient's legs on a treadmill while they are suspended in a harness.
In this study, subjects with confirmed diagnosis of Multiple Sclerosis were randomized into one of two treatment arms. Subjects in the Lokomat arm trained on the Lokomat with a supervising physical therapist for 20-30 minutes/session 3 times/week. The Lokomat is a robotic exoskeleton which enables the subject to step on a moving treadmill. Subjects were suspended in a harness while in the Lokomat with full to partial body weight support as needed. After the training in the Lokomat, they practiced overground walking for 10 minutes.
The other treatment arm had subjects engage in resistance training with weights and resistance elastic bands matched to the Lokomat group for intensity, duration and frequency. they did not practice overground walking.
Primary outcome measure was speed to accomplish 25' timed walk.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 38 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of California, Los Angeles is the lead sponsor of 1,142 studies on the registry; 192 are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 66 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill.
Device: Lokomat
resistive training using weights and therabands
Procedure: resistive training
locomotor training using body weight support on a treadmill
resistive training using theraband and/or weights
Walking Speed as Assessed by 25' Timed Walk
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.
Time frame: at beginning,mid point, end and 12 weeks after intervention
Distance
distance assessed by 6 minute walk test
Time frame: baseline, mid point, end and 12 weeks after training
Fatigue
fatigue 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.
Time frame: baseline, mid, completetion, 3 months post
PASAT
Cognitive 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
Time frame: baseline, mid, completion, 3 months post training
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.
| Milestone | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training |
|---|---|---|
| Started | 17 | 19 |
| Completed | 17 | 19 |
| Not completed | 0 | 0 |
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.
| seconds | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training |
|---|---|---|
| 25"TW baseline | 22.7 ± 17.6 | 10.6 ± 4.9 |
| 25'TW midpoint | 23.9 ± 20.9 | 9.8 ± 4.3 |
| 25'TW end point | 19.4 ± 15.2 | 9.6 ± 3.7 |
| 25'TW post | 21.7 ± 16.7 | 10.5 ± 4.3 |
distance assessed by 6 minute walk test
| feet | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training |
|---|---|---|
| 6 min walk baseline | 367 ± 241 | 753 ± 232.3 |
| 6 min walk midpoint | 474 ± 354 | 813 ± 253.8 |
| 6 minute walk end point | 436 ± 288 | 769 ± 261.9 |
| 6 minute walk post | 457 ± 300.5 | 742 ± 248.2 |
fatigue 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.
| units on a scale | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training |
|---|---|---|
| MFIS baseline | 34.1 ± 14.1 | 37.7 ± 15.6 |
| MFIS mid point | 26.7 ± 13.7 | 29.4 ± 15.0 |
| MFIS end point | 26.8 ± 16.6 | 29.9 ± 17.7 |
| MFIS post | 27.4 ± 19.8 | 35.3 ± 15.9 |
Cognitive 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
| units on a scale | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training |
|---|---|---|
| PASAT baseline | 48.2 ± 5.1 | 46.8 ± 3.8 |
| PASAT Mid point | 0.06 ± 1.17 | 0.42 ± 1.03 |
| PASAT end point | 1.3 ± 1.13 | 0.58 ± 1.03 |
| PASAT post | 1.90 ± 1.13 | -0.91 ± 1.13 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lokomat Training Using Body Weight Support on a Treadmill | — | 0/17 (0%) | 0/17 (0%) |
| Resistive Training | — | 0/19 (0%) | 0/19 (0%) |
| Age, Categorical(Participants) | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 19 | 36 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training | Total |
|---|---|---|---|
| Female | 9 | 14 | 23 |
| Male | 8 | 5 | 13 |
| Region of Enrollment(participants) | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training | Total |
|---|---|---|---|
| United States | 17 | 19 | 36 |
| EDSS(units on a scale) | Lokomat Training Using Body Weight Support on a Treadmill | Resistive Training | Total |
|---|---|---|---|
| Mean | 6.5 (5.5 to 6.5) | 6.0 (5 to 6.5) | 6.3 (5 to 6.5) |
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University of California, Los Angeles