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Ambulation Study in Multiple Sclerosis

This study has been completed.
Sponsor:
Information provided by:
Brown, Theodore R., M.D., MPH
ClinicalTrials.gov Identifier:
NCT00424359
First received: January 17, 2007
Last updated: May 12, 2011
Last verified: May 2011
  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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by Brown, Theodore R., M.D., MPH:

Estimated Enrollment: 40
Study Start Date: April 2005
Study Completion Date: January 2009
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Brown, Theodore R., M.D., MPH
Investigators
Principal Investigator: Theodore R Brown, MD, MPH MS Center at Evergreen
  More Information

Additional Information:
No publications provided

Responsible Party: Theodore R. Brown, MD Mph, MS Center at Evergreen
ClinicalTrials.gov Identifier: NCT00424359     History of Changes
Obsolete Identifiers: NCT01355250
Other Study ID Numbers: WIRB 20050607, Pfizer Inc, Independent Grants 235-14-22
Study First Received: January 17, 2007
Last Updated: May 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Brown, Theodore R., M.D., MPH:
Mulitple Sclerosis
Ambulation

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014