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

Hadassah Medical Center

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis

Treatments: Device: robot-assisted gait training (RAGT); Device: conventional walking training (CWT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00843128

0558-08-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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40 participants in 2 patient groups

1: RAGT

Experimental group

Description:

Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks

Treatment:

Device: robot-assisted gait training (RAGT)

2: Control

Active Comparator group

Description:

The control group will be treated by CWT, 12 sessions in three weeks.

Treatment:

Device: conventional walking training (CWT)