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Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

NCT ID: NCT00331747

Last Updated: 2006-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Glatiramer acetate

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Uri Givon, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center; Tel Aviv University

Anat Achiron, MD, PhD

Role: STUDY_CHAIR

Sheba Medical Center; Tel Aviv University

Locations

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Multiple Sclerosis Center, Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Uri Givon, MD

Role: CONTACT

Phone: +972-35304451

Email: [email protected]

Other Identifiers

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SHEBA-05-3985-UG-CTIL

Identifier Type: -

Identifier Source: org_study_id