Impact of Walking Practice on Persons With PD

University of Texas Southwestern Medical Center13 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Walking program with ankle braceOTHER

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.

Individualized walking programOTHER

Walking program will include instructions on walking activities at home such as time of walking

Walking program with custom braces.OTHER

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.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 90 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5 2. Age between 30 and 90. 3. Ability to walk 150 feet independently over level surfaces with or without an assistive device. 4. Hoehn and Yahr stage 1-4. 5. Less than 10 full heel raises in single limb stance bilaterally. 6. Adequate insurance/funding to pay for physical therapy evaluation and AFO devices. Exclusion Criteria: 1. Body mass index greater than 40. 2. Passive dorsiflexion range of motion less than approximately neutral (90 degrees) 3. Any other uncontrolled health condition for which gait training is contraindicated

Locations (1)

University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 6MWT will be done at initial testing and 12 months

Secondary Outcomes

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.

Time frame: Testing will be done at initial testing and 12 months

Data from ClinicalTrials.gov

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