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

Study Overview
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Brief Summary
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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
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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).

Official Title
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Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Ankle foot orthosis


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Ankle foot orthosis fitting<br>All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings. | Device: Ankle foot orthosis<br>* Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.<br>* Other names: Tamarack with check strap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing | 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. | Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing | 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. | Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, ankle foot orthosis (AFO), gait