The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients

Study Overview
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Brief Summary
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Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients with severe walking disabilities (Expanded Disability Status Scale [EDSS] 5.5-7) as compared to regular physiotherapy. Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional walking training (CWT) in a group of stable MS patients (n=40) during an outpatient rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized diseases. All patients will sign an informed consent. Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome measures will be the Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and RAND questioner for quality of life. All tests will be performed by an external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and six months. Importance: We anticipated that Robot-assisted gait training will be found as feasible and may be an effective therapeutic option in MS patients with severe walking disabilities.

Official Title
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Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Device: robot-assisted gait training (RAGT)
* Device: conventional walking training (CWT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: chronic or secondary progressive MS patients with EDSS between 5.5-7, stable treatment 3 months before study entry. Exclusion Criteria: Other generalized diseases. Pregnancy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1: RAGT<br>Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks | Device: robot-assisted gait training (RAGT)<br>* 20 patients will be treated with RAGT, 12 sessions over three weeks.<br>|
| Active Comparator: 2: Control<br>The control group will be treated by CWT, 12 sessions in three weeks. | Device: conventional walking training (CWT)<br>* The control group will be treated by CWT, 12 sessions in three weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance |  | At baseline, after three weeks, and at follow-up after 3 months and six months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life. |  | At baseline, after three weeks, and at follow-up after 3 months and six months. |