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

NCT00843128 | Completed Phase 2

• 1 other identifier: 0558-08-HMO-CTIL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

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

  At baseline, after three weeks, and at follow-up after 3 months and six months.

Secondary Outcomes (1)

• Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life.

  At baseline, after three weeks, and at follow-up after 3 months and six months.

Study Arms (2)

1: RAGT

EXPERIMENTAL

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

Device: robot-assisted gait training (RAGT)

2: Control

ACTIVE COMPARATOR

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

Device: conventional walking training (CWT)

Interventions

robot-assisted gait training (RAGT) DEVICE

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

1: RAGT

conventional walking training (CWT) DEVICE

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

2: Control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Other generalized diseases.
• Pregnancy.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah University Hospital

Jerusalem, 91240, Israel

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Zeev Meiner, M.D.

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 12, 2009
• First Posted: February 13, 2009
• Study Start: March 1, 2009
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: April 8, 2011

Record last verified: 2009-02

Locations

IL (1)