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

This study has been completed.
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00843128
First received: February 12, 2009
Last updated: April 7, 2011
Last verified: February 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
 Device: robot-assisted gait training (RAGT)
Device: conventional walking training (CWT)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance [ Time Frame: At baseline, after three weeks, and at follow-up after 3 months and six months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life. [ Time Frame: At baseline, after three weeks, and at follow-up after 3 months and six months. ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: March 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: RAGT
Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks
 Device: robot-assisted gait training (RAGT)
20 patients will be treated with RAGT, 12 sessions over three weeks.
Active Comparator: 2: Control
The control group will be treated by CWT, 12 sessions in three weeks.
 Device: conventional walking training (CWT)
The control group will be treated by CWT, 12 sessions in three weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843128

Locations
Israel
Hadassah University Hospital
Jerusalem, Israel, 91240
Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Zeev Meiner, M.D. Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Dr. Zeev Meiner, Hadassah Medical Center
ClinicalTrials.gov Identifier: NCT00843128     History of Changes
Other Study ID Numbers: 0558-08-HMO-CTIL
Study First Received: February 12, 2009
Last Updated: April 7, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013