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Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

S

Sheba Medical Center

Status

Unknown

Conditions

Multiple Sclerosis

Treatments

Drug: Glatiramer acetate

Study type

Interventional

Funder types

Other

Identifiers

NCT00331747
SHEBA-05-3985-UG-CTIL

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Central trial contact

Uri Givon, MD

Data sourced from clinicaltrials.gov

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