Ambulation Study in Multiple Sclerosis - Full Text View

Purpose

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.

Condition

Multiple Sclerosis

MedlinePlus related topics:

Multiple Sclerosis

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

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

Further study details as provided by Evergreen Healthcare:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	40
Study Start Date:	April 2005
Estimated Study Completion Date:	January 2011

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Subjects with Multiple Sclerosis

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424359

Contacts


Contact: Jennifer McAleenan	425-899-5371	jkmcaleenan@evergreenhealthcare.org

Locations


United States, Washington
	MS Center at Evergreen	Recruiting
	Kirkland, Washington, United States, 98034
	Contact: Theodore R Brown, MD, MPH 425-899-5350

Sponsors and Collaborators

Evergreen Healthcare

Investigators


Principal Investigator:	Theodore R Brown, MD, MPH	MS Center at Evergreen

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	MS Center at Evergreen ( Theodore R. Brown, MD Mph )
Study ID Numbers:	WIRB 20050607, Pfizer Inc, Independent Grants 235-14-22
First Received:	January 17, 2007
Last Updated:	May 12, 2008
ClinicalTrials.gov Identifier:	NCT00424359
Health Authority:	United States: Institutional Review Board