Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

What Was Tested

The trial (not phased) is built around Glatiramer Acetate for multiple sclerosis.

During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

20 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Clinical diagnosis of multiple sclerosis. EDSS less than 5.5. No cognitive disability.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: EDSS over 5.5; inability to cooperate with gait analysis.

How the Study Was Run

Design: non-randomized, single-group and open-label.

Being open-label, the Glatiramer Acetate study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-05.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Computerized gait analysis: at the beginning of treatment and after 1 year.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Glatiramer Acetate in 20 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Glatiramer Acetate compound page, Multiple sclerosis research.