- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01074827
Improving Gait in Multiple Sclerosis (MS) - Strength Training or Treadmill Walking?
July 6, 2015 updated by: St. Olavs Hospital
Strength Training or Treadmill Walking? A Randomized Control Study on the Effect on Gait in Multiple Sclerosis
The objective of this study is to evaluate the effect of strength training for the lower extremities and treadmill training on walking ability in persons with Multiple Sclerosis.
The study is a randomized control trial with two groups and the intervention is 8 weeks of intensive strength training or treadmill walking.
Primary outcome measure is walking ability, secondary outcome measures are balance, work economy and strength.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway, 7006
- St. Olavs Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with Multiple Sclerosis,classified as relapsing remitting,or primary/secondary progressive
- Expanded Disability Status Scale (EDSS)score of ≤ 6
- Reduced walking ability (subjectively experienced)
Exclusion Criteria:
- persons with a level of ataxia, clinically assessed, that would affect their ability to perform the training.
- spasticity requiring stretching og treatment with baclofen.
- Other, not MS-related, conditions affecting walking ability.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treadmill group
Specific gait training on treadmill
|
Eight weeks of intensive strength training or treadmill training
|
Experimental: Strength training group
Eight weeks of intensive strength training
|
Eight weeks of intensive strength training or treadmill training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Walking ability
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Strength
Time Frame: 8 weeks
|
8 weeks
|
Work economy O2
Time Frame: 8 weeks
|
8 weeks
|
Balance
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Siri M, Brændvik, St. Olavs Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
February 23, 2010
First Submitted That Met QC Criteria
February 23, 2010
First Posted (Estimate)
February 24, 2010
Study Record Updates
Last Update Posted (Estimate)
July 8, 2015
Last Update Submitted That Met QC Criteria
July 6, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09/225
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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