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

NCT00843128 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2011-04-08

No results posted yet for this study

Summary

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.

Conditions

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.

Sponsors & Collaborators

  • Hadassah Medical Organization

    lead OTHER

Principal Investigators

  • Zeev Meiner, M.D. · Hadassah Medical Organization

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • Israel

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00843128 on ClinicalTrials.gov