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

July 6, 2015 updated by: Karen McCain, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center, School of Health Professions

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing
Time Frame: Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment
Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes. They will be allowed to use assistive devices if necessary.
Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Texas Southwestern Medical Center

Investigators

  • Principal Investigator: Karen J McCain, DPT, UTSW Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 21, 2013

First Posted (Estimate)

February 26, 2013

Study Record Updates

Last Update Posted (Estimate)

August 3, 2015

Last Update Submitted That Met QC Criteria

July 6, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD AFO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on Ankle foot orthosis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Indonesia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe