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

University of Texas Southwestern Medical Center4 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Parkinson's Disease

Interventions

Ankle foot orthosisDEVICE

Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

UT Southwestern Medical Center, School of Health Professions

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment

Secondary Outcomes

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.

Time frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment.

Data from ClinicalTrials.gov

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