The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)
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|ClinicalTrials.gov Identifier: NCT01947582|
Recruitment Status : Completed
First Posted : September 20, 2013
Results First Posted : June 1, 2015
Last Update Posted : March 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Device: Ankle foot orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effects of Ankle Foot Orthoses (AFOs) on Mobility in Persons With Multiple Sclerosis (MS)|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Application of ankle foot orthosis
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Device: Ankle foot orthosis
The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.
- Change in Walking Distance During 6-Minute Walk Test [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. They will be asked to rate their level of exertion upon completion of walking on the rate of perceived exertion scale.
- Change in Impact of MS on Fatigue Using the 12-Item Walk Scale [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]The 12-Item Walk Scale is a paper and pencil test that asks persons with MS to rate their level of fatigue when doing functional tasks. The maximum possible score is 60 points and the lowest possible score is 12. Higher scores indicate a greater impact on walking than lower scores.
- Change in Step Length Using the GAITRite Computerized Gait Analysis System [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor.
- Number of Persons With Change in Muscle Activity Using Surface Electromyography (EMG) [ Time Frame: Assessed at visit 2 (week 1) and week 24 ]Surface EMG is done on key muscles in the lower extremity (quadriceps, anterior tibialis, gastrocnemius, soleus) during computerized gait assessment. Changes in amplitude of muscle activity or timing of muscle activity would indicate, for example, increases in strength or changes in timing of muscles which might indicate motor learning as a result of wearing the ankle foot orthosis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01947582
|United States, Texas|
|UT Southwestern Medical Center School of Health Professions|
|Dallas, Texas, United States, 75223|
|Principal Investigator:||Karen J McCain, PT, DPT, NCS||University of Texas Southwestern Medical Center|