Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

Study Overview
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Brief Summary
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The primary aim of this study is to: Collect pilot data on the effect of task-specific lower extremity training using the Anklebot on subjects with Multiple Sclerosis (MS) and who have foot drop; Collect pilot data on the use of combination therapy on improving gait in subjects with MS. This therapy will use both Anklebot training and robot-assisted gait training. Hypothesis: Both trainings will result in improved walking performance, but the combination therapy will result in greater gains than ankle training alone.

Official Title
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Effect of Robot-assisted Training on Foot Drop in Multiple Sclerosis

Conditions
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MS (Multiple Sclerosis)

Intervention / Treatment
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* Device: Anklebot
* Device: Lokomat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of MS by McDonald criteria (McDonald, Compston et al. 2001). EDSS level between 3.5-5.5, who report ambulation problems. Presence of unilateral foot drop that is clinically apparent to the PI or PI designate. Must be able to ambulate 25 feet without an assisting device. Exclusion Criteria: Cardiovascular: recent MI < 4 wk, uncontrolled HTN >190/110 mmHg. History of uncontrolled diabetes. Symptoms of orthostasis when standing up. Circulatory problems, history of vascular claudication or pitting edema. Unable to fully understand instructions in order to use the equipment or the process of the study. Body weight over 150 kg. Lower extremity injuries that limit range of motion or function. Joint problems (hip or leg) that limit range of motion or cause pain with movement despite treatment. Unstable fractures. Pressure sores with any skin breakdown in areas in contact with the body harness or Lokomat apparatus. Chronic and ongoing alcohol or drug abuse. Pre-morbid, ongoing depression or psychosis. Ongoing physical therapy. Pregnancy (self-reported) PI's determination of inability to complete the test protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Arm 1<br>Focused Ankle Training | Device: Anklebot<br>* The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training games, the Anklebot can assist ankle movement throughout 3 planes.<br>|
| Experimental: Arm 2<br>Combination Therapy | Device: Anklebot<br>* The Anklebot is a robotic device that is worn via a leather boot and knee brace (Fig.1). As the participant goes through a series of ankle-training games, the Anklebot can assist ankle movement throughout 3 planes.<br>Device: Lokomat<br>* The Lokomat is a motor driven exoskeleton device that employs a body weight support suspension system and treadmill. Attached to the lower limbs, the Lokomat moves the subject's legs over a treadmill through position controlled trajectories that mimic normal human gait patterns.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ankle accuracy and stiffness |  | At inclusion, after 8 sessions, after 16 sessions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait assessments (e.g., 6-Minute Walk, Timed 25-Foot Walk) |  | At inclusion, after every 4 sessions | 
| Functional assessments (EDSS, MS Functional Composite) |  | At inclusion, after 8 sessions, after 16 sessions | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robot, treadmill, foot drop, rehabilitation, gait