Ambulation Study in Multiple Sclerosis

Brown, Theodore R., M.D., MPH

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Identifiers

NCT00424359

WIRB 20050607

Independent Grants 235-14-22

Pfizer Inc

Details and patient eligibility

About

This is a study comparing clinical tests of walking and balance. The goal of this study is to discover which of those tests are best at predicting walking problems due to MS.

Full description

This study includes:

Three study visits to the MS Center at Evergreen; wearing a pedometer for two, one-week periods to record walking during regular daily activities; keeping a diary for any walking problems such as falls and slips.

Subjects must meet the following criteria:

Diagnosis of MS (any form); 18-70 years of age; be on stable MS treatment OR no MS treatment for the last three months; no scheduled hospitalization in the next six months.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject must have sufficient cognitive ability to maintain a falls diary and follow instructions for wearing the pedometer
• Subject must have clinically definite MS according to McDonald criteria
• Subject must have EDSS between 0-6.5
• Subject must be aged 18-70
• Subjects must be given informed consent
• Subjects must be stable on disease modifying therapy or no therapy for at least three months before entry into study

Exclusion criteria

• No MS relapse within the last 30 days
• Subjects must have no scheduled major hospitalizations or surgical procedures during the study time frame. Hospitalization during the study may result in removal from the study
• Medical conditions other than MS that might significantly impact ambulatory activity (such as angina pectoris) in the judgement of the investigators
• History or suspicion of non-compliance in the judgement of the investigators