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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00843128
Recruitment Status : Completed
First Posted : February 13, 2009
Last Update Posted : April 8, 2011
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date  ICMJE February 12, 2009
First Posted Date  ICMJE February 13, 2009
Last Update Posted Date April 8, 2011
Study Start Date  ICMJE March 2009
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 12, 2009)
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. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients
Official Title  ICMJE Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Device: robot-assisted gait training (RAGT)
    20 patients will be treated with RAGT, 12 sessions over three weeks.
  • Device: conventional walking training (CWT)
    The control group will be treated by CWT, 12 sessions in three weeks.
Study Arms  ICMJE
  • Experimental: 1: RAGT
    Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks
    Intervention: Device: robot-assisted gait training (RAGT)
  • Active Comparator: 2: Control
    The control group will be treated by CWT, 12 sessions in three weeks.
    Intervention: Device: conventional walking training (CWT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: February 12, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00843128
Other Study ID Numbers  ICMJE 0558-08-HMO-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. Zeev Meiner, Hadassah Medical Center
Study Sponsor  ICMJE Hadassah Medical Organization
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zeev Meiner, M.D. Hadassah Medical Organization
PRS Account Hadassah Medical Organization
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP