Impact of Walking Practice on Persons With PD

March 20, 2019 updated by: Karen McCain, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

13

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

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

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Distance Walked on 6-Minute Walk Test (6MWT)
Time Frame: 6MWT will be done at initial testing and 12 months
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
Time Frame: Testing will be done at initial testing and 12 months
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Daily Activity as Measured by Steps Per Day
Time Frame: Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months
Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded.
Total steps per day will be measured at the start of the study and a week prior to testing at 6 months, and 12 months

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

April 1, 2014

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

April 10, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Actual)

March 22, 2019

Last Update Submitted That Met QC Criteria

March 20, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD walking study

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.

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