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Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2006 by Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00331747
First Posted: May 31, 2006
Last Update Posted: July 7, 2006
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.
Information provided by:
Sheba Medical Center
  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
Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00331747     History of Changes
Other Study ID Numbers: SHEBA-05-3985-UG-CTIL
First Submitted: May 30, 2006
First Posted: May 31, 2006
Last Update Posted: July 7, 2006
Last Verified: July 2006

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