Multiple Sclerosis
Conditions
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.
Interventions
20 patients will be treated with RAGT, 12 sessions over three weeks.
DEVICEconventional walking training (CWT)
The control group will be treated by CWT, 12 sessions in three weeks.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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. |
Countries
Israel
Outcome results
None listed