Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease

Not Applicable

Terminated

• Conditions: Parkinson's Disease
• Interventions: Device: Ankle foot orthosis

• Registration Number: NCT01798927
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.

Detailed Description

This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-21
• Study First Posted: 2013-02-26
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Results First Submitted: 2015-05-13
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-06
• Last Update Submitted: 2015-07-06
• Results First Posted: 2015-08-03
• Last Update Posted: 2015-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Confirmed diagnosis of Parkinson's Disease
• Between the ages of 50 and 75
• Ability to walk 150 feet independently over level surfaces with or without an assistive device
• Stable medication usage for the duration of the study (10 weeks)
• Obvious gait dysfunction (Observational Gait Analysis)
• Score of greater than 22 on the Short Orientation-Memory-Concentration Test

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Exclusion Criteria

• Body mass index of greater than 35
• Dorsiflexion range of motion less than neutral (90 degrees)
• Any other uncontrolled health condition for which gait training is contraindicated

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ankle foot orthosis fitting	Ankle foot orthosis	All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.

Primary Outcome Measures

Name	Time	Method
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing	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.

Trial Locations

Locations (1)

UT Southwestern Medical Center, School of Health Professions; 🇺🇸 Dallas, Texas, United States