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Clinical Trials/NCT00424359
NCT00424359
Completed
Not Applicable

A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis

Brown, Theodore R., M.D., MPH0 sites40 target enrollmentApril 2005

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Brown, Theodore R., M.D., MPH
Enrollment
40
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2005
End Date
January 2009
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

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

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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