Finished
The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients
NCT00843128 · Hadassah Medical Organization · Updated 8 April 2011
- What is being tested
- robot-assisted gait training (RAGT); conventional walking training (CWT)
- For
- Multiple Sclerosis
- Kind of study
- Tests a treatment or device on volunteers. Phase 2.
- Who can join
- Ages 18 years to 70 years. About 40 people. The full rules are on the registry page.
- Where
- Israel
- When
- Starts or started March 2009, ends Aug 2010. Registered 13 Feb 2009.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Hadassah University HospitalJerusalem, Israel
