Impact of Walking Practice on Persons With PD

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02113189
• Other study ID #: PD walking study
• Status: Terminated
• Phase: N/A
• Start date: April 2014
• Est. completion date: October 2016

Study information

• Verified date: March 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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

Locations

Country	Name	City	State
United States	University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Daily Activity as Measured by Steps Per Day	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
Primary	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	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