Impact of Walking Practice on Persons With PD

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 leg brace on walking endurance in individuals with Parkinson's disease.

Detailed Description
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This is a randomized, repeated measures, matched group study. There will be three groups of participants, 20 participants per group, 60 participants total. Group one (G1) will receive custom-fabricated bilateral braces and a standardized home walking/exercise program. Group two (G2) will receive an off-the shelf ankle support and standardized home walking/exercise program. Group three (G3) will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. Subjects will be followed for one year during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 6 months for the duration of the study for testing as well as for other visits as noted in the table below.

Official Title
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The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Other: Walking program with ankle brace
* Other: Individualized walking program
* Other: Walking program with custom braces.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5 Age between 30 and 90. Ability to walk 150 feet independently over level surfaces with or without an assistive device. Hoehn and Yahr stage 1-4. Less than 10 full heel raises in single limb stance bilaterally. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices. Exclusion Criteria: Body mass index greater than 40. Passive dorsiflexion range of motion less than approximately neutral (90 degrees) Any other uncontrolled health condition for which gait training is contraindicated

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 90 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Walking program with ankle brace<br>This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program. | Other: Walking program with ankle brace<br>* Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.<br>|
| Experimental: Individualized walking program<br>This group will receive a customized walking program. | Other: Individualized walking program<br>* Walking program will include instructions on walking activities at home such as time of walking<br>|
| Experimental: Walking program with custom braces<br>This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program. | Other: Walking program with custom braces.<br>* Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Distance Walked on 6-Minute Walk Test (6MWT) | Each participant walks at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary. | 6MWT will be done at initial testing and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System | Participants will be asked to walk on a 12-16 foot long vinyl pad placed on the floor. The mat will record and analyze temporal and spatial parameters. | Testing will be done at initial testing and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gait, Parkinson's disease