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

Phase 2

Completed

• Conditions: Multiple Sclerosis
• Interventions: Device: robot-assisted gait training (RAGT); Device: conventional walking training (CWT)

• Registration Number: NCT00843128
• Lead Sponsor: Hadassah Medical Organization

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Study Start: 2009-03
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1: RAGT	robot-assisted gait training (RAGT)	Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks
2: Control	conventional walking training (CWT)	The control group will be treated by CWT, 12 sessions in three weeks.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Hadassah University Hospital; 🇮🇱 Jerusalem, Israel