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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

robot-assisted gait training (RAGT)

conventional walking training (CWT)

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

chronic or secondary progressive MS patients with EDSS between 5.5-7,
stable treatment 3 months before study entry.

Exclusion Criteria:

Other generalized diseases.
Pregnancy.

Sites / Locations

Hadassah University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1: RAGT

2: Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance

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.

Full Information

NCT ID

NCT00843128

First Posted

February 12, 2009

Last Updated

April 7, 2011

Sponsor

Hadassah Medical Organization

1. Study Identification

Unique Protocol Identification Number

NCT00843128

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1: RAGT

Arm Type

Experimental

Arm Description

Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks

Arm Title

2: Control

Arm Type

Active Comparator

Arm Description

The control group will be treated by CWT, 12 sessions in three weeks.

Intervention Type

Device

Intervention Name(s)

robot-assisted gait training (RAGT)

Intervention Description

20 patients will be treated with RAGT, 12 sessions over three weeks.

Intervention Type

Device

Intervention Name(s)

conventional walking training (CWT)

Intervention Description

The control group will be treated by CWT, 12 sessions in three weeks.

Primary Outcome Measure Information:

Title

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.

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: chronic or secondary progressive MS patients with EDSS between 5.5-7, stable treatment 3 months before study entry. Exclusion Criteria: Other generalized diseases. Pregnancy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Zeev Meiner, M.D.

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah University Hospital

City

Jerusalem

ZIP/Postal Code

91240

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

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

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