Ambulation Study in Multiple Sclerosis

NCT ID: NCT00424359

Last Updated: 2011-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-01-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDIV

Sponsor Role lead

Responsible Party

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MS Center at Evergreen

Principal Investigators

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Theodore R Brown, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

MS Center at Evergreen

Other Identifiers

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Pfizer Inc

Identifier Type: -

Identifier Source: secondary_id

Independent Grants 235-14-22

Identifier Type: -

Identifier Source: secondary_id

WIRB 20050607

Identifier Type: -

Identifier Source: org_study_id

NCT01355250

Identifier Type: -

Identifier Source: nct_alias

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