Back to resultsGait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate
Primary Purpose
Multiple Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Glatiramer acetate
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
Eligibility 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
Sites / Locations
- Multiple Sclerosis Center, Sheba Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Computerized gait analysis: at the beginning of treatment and after 1 year
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00331747
Brief Title
Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate
Official Title
Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
Brief Summary
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.
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.
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
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Glatiramer acetate
Primary Outcome Measure Information:
Title
Computerized gait analysis: at the beginning of treatment and after 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uri Givon, MD
Phone
+972-35304451
Email
urigi@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uri Givon, MD
Organizational Affiliation
Sheba Medical Center; Tel Aviv University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anat Achiron, MD, PhD
Organizational Affiliation
Sheba Medical Center; Tel Aviv University
Official's Role
Study Chair
Facility Information:
Facility Name
Multiple Sclerosis Center, Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Uri Givon, MD
12. IPD Sharing Statement
Learn more about this trial
Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate
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