The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients
NCT ID: NCT00843128
Last Updated: 2011-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2009-03-31
2010-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
SINGLE
Study Groups
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1: RAGT
Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks
robot-assisted gait training (RAGT)
20 patients will be treated with RAGT, 12 sessions over three weeks.
2: Control
The control group will be treated by CWT, 12 sessions in three weeks.
conventional walking training (CWT)
The control group will be treated by CWT, 12 sessions in three weeks.
Interventions
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robot-assisted gait training (RAGT)
20 patients will be treated with RAGT, 12 sessions over three weeks.
conventional walking training (CWT)
The control group will be treated by CWT, 12 sessions in three weeks.
Eligibility Criteria
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Inclusion Criteria
2. stable treatment 3 months before study entry.
Exclusion Criteria
2. Pregnancy.
18 Years
70 Years
ALL
No
Sponsors
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Hadassah Medical Organization
OTHER
Responsible Party
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Hadassah Medical Center
Principal Investigators
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Zeev Meiner, M.D.
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Locations
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Hadassah University Hospital
Jerusalem, , Israel
Countries
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Other Identifiers
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0558-08-HMO-CTIL
Identifier Type: -
Identifier Source: org_study_id
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