Locomotor Training in Persons With Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Robotic Locomotor Training in Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: Lokomat
* Procedure: resistive training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Persons with Secondary progressive or Primary Progressive Multiple Sclerosis who are ambulatory with difficulty and /or assistive device Exclusion Criteria: Ataxia Unable to ambulate Within 3 months of exacerbation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* locomotor training using body weight support on a treadmill<br>|
| Active Comparator: 2<br>resistive training using weights and therabands | Procedure: resistive training<br>* resistive training using theraband and/or weights<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | at beginning,mid point, end and 12 weeks after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distance | distance assessed by 6 minute walk test | 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. | 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 | baseline, mid, completion, 3 months post training | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impaired ambulation