Multiple SclerosisNCT00424359
Ambulation Study in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jan 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with Multiple Sclerosis
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Keywords
- Mulitple Sclerosis, Ambulation
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startApr 2005
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Investigators
- Theodore R Brown, MD, MPH, Principal investigator, MS Center at Evergreen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424359
- Sponsor's protocol ID
- WIRB 20050607
- Other IDs
- Pfizer Inc, Independent Grants 235-14-22
- Status last verified
- May 2011
- First submitted
- 17 Jan 2007
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Clinical Indices as Predictors of Ambulatory Effectiveness in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT00424359
- Acronym / sponsor ID
- WIRB 20050607
- Conditions
- Multiple Sclerosis
- Keywords
- Mulitple Sclerosis, Ambulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Brown, Theodore R., M.D., MPH
- Study start
- Apr 2005
- Study completion
- Jan 2009 (actual)
- First posted
- 19 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with Multiple Sclerosis
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Theodore R Brown, MD, MPH principal investigator
MS Center at Evergreen
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Brown, Theodore R., M.D., MPH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2011.