Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by Sheba Medical Center.
Recruitment status was  Recruiting
Information provided by:
Sheba Medical Center Identifier:
First received: May 30, 2006
Last updated: July 5, 2006
Last verified: July 2006

Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients.

During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

Condition Intervention
Multiple Sclerosis
Drug: Glatiramer acetate

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate

Resource links provided by NLM:

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Computerized gait analysis: at the beginning of treatment and after 1 year

Estimated Enrollment: 20
Study Start Date: May 2006
Detailed Description:

Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist.

Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center.

Repeat gait analysis will be performed after one year of treatment.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of multiple sclerosis
  • EDSS less than 5.5
  • No cognitive disability

Exclusion Criteria:

  • EDSS over 5.5
  • Inability to cooperate with gait analysis
  Contacts and Locations
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Please refer to this study by its identifier: NCT00331747

Contact: Uri Givon, MD +972-35304451

Multiple Sclerosis Center, Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Uri Givon, MD         
Sponsors and Collaborators
Sheba Medical Center
Principal Investigator: Uri Givon, MD Sheba Medical Center; Tel Aviv University
Study Chair: Anat Achiron, MD, PhD Sheba Medical Center; Tel Aviv University
  More Information Identifier: NCT00331747     History of Changes
Other Study ID Numbers: SHEBA-05-3985-UG-CTIL 
Study First Received: May 30, 2006
Last Updated: July 5, 2006
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Glatiramer Acetate
Adjuvants, Immunologic
Antirheumatic Agents
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs processed this record on May 22, 2016