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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
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00331747
First received: May 30, 2006
Last updated: July 5, 2006
Last verified: July 2006
History of Changes
  Purpose

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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00331747

Contacts
Contact: Uri Givon, MD +972-35304451 urigi@sheba.health.gov.il

Locations
Israel
Multiple Sclerosis Center, Sheba Medical Center Recruiting
Tel Hashomer, Israel, 52621
Principal Investigator: Uri Givon, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
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

No publications provided

ClinicalTrials.gov 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
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
 Immune System Diseases
Pathologic Processes
Copolymer 1
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents

ClinicalTrials.gov processed this record on May 23, 2013