Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
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|ClinicalTrials.gov Identifier: NCT01798927|
Recruitment Status : Terminated (Modifications are being made to protocol)
First Posted : February 26, 2013
Results First Posted : August 3, 2015
Last Update Posted : August 3, 2015
|Condition or disease||Intervention/treatment||Phase|
|Parkinson's Disease||Device: Ankle foot orthosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.|
|Study Start Date :||December 2012|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
Ankle foot orthosis fitting
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Device: Ankle foot orthosis
Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Other Name: Tamarack with check strap
- Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment ]Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze step length.
- Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. ]Surface electromyography will be done on key muscles in the lower extremity (quads, anterior tibialis, gastrocnemius) during computerized gait assessment. Changes in EMG activity include things such as increases in amplitude or timing that might indicate increases in strength or motor learning as a result of wearing the ankle foot orthosis.
- Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing [ Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment ]Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
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): NCT01798927
|United States, Texas|
|UT Southwestern Medical Center, School of Health Professions|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Karen J McCain, DPT||UTSW Medical Center|