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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: August 2010

Interventions

  • Device: robot-assisted gait training (RAGT)
    • 20 patients will be treated with RAGT, 12 sessions over three weeks.
  • Device: conventional walking training (CWT)
    • The control group will be treated by CWT, 12 sessions in three weeks.

Arms, Groups and Cohorts

  • Experimental: 1: RAGT
    • Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks
  • Active Comparator: 2: Control
    • The control group will be treated by CWT, 12 sessions in three weeks.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. chronic or secondary progressive MS patients with EDSS between 5.5-7, 2. stable treatment 3 months before study entry. Exclusion Criteria:

1. Other generalized diseases. 2. Pregnancy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hadassah Medical Organization
  • Provider of Information About this Clinical Study
    • Dr. Zeev Meiner, Hadassah Medical Center
  • Overall Official(s)
    • Zeev Meiner, M.D., Principal Investigator, Hadassah Medical Organization

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