Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

Multiple Sclerosis Clinical Trial

Official title:

Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00331747
• Other study ID #: SHEBA-05-3985-UG-CTIL
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2006
• Last updated: July 5, 2006
• Start date: May 2006

Study information

• Verified date: July 2006
• Source: Sheba Medical Center
• Contact: Uri Givon, MD
• Phone: +972-35304451
• Email: urigi[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Glatiramer acetate

Locations

Country	Name	City	State
Israel	Multiple Sclerosis Center, Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Computerized gait analysis: at the beginning of treatment and after 1 year