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NCT00424359 Clinical Trial

Ambulation Study in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00424359
Other study ID # WIRB 20050607
Secondary ID Pfizer IncIndepe
Status Completed
Phase N/A
First received January 17, 2007
Last updated May 12, 2011
Start date April 2005
Est. completion date January 2009

Study information
Verified date May 2011
Source Brown, Theodore R., M.D., MPH
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Other known NCT identifiers
  • NCT01355250

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date January 2009
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Brown, Theodore R., M.D., MPH
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