Back to resultsImpact of Walking Practice on Persons With PD
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Walking program with ankle brace
Individualized walking program
Walking program with custom braces.
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring gait, Parkinson's disease
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
- Age between 30 and 90.
- Ability to walk 150 feet independently over level surfaces with or without an assistive device.
- Hoehn and Yahr stage 1-4.
- Less than 10 full heel raises in single limb stance bilaterally.
- Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.
Exclusion Criteria:
- Body mass index greater than 40.
- Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
- Any other uncontrolled health condition for which gait training is contraindicated
Sites / Locations
- University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Walking program with ankle brace
Individualized walking program
Walking program with custom braces
Arm Description
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
This group will receive a customized walking program.
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02113189
First Posted
April 10, 2014
Last Updated
March 20, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02113189
Brief Title
Impact of Walking Practice on Persons With PD
Official Title
The Long Term Impact of Walking Practice on Functional Mobility and Quality of Life in Persons With Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Inadequate funding to continue the study
Study Start Date
April 2014 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
gait, Parkinson's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Walking program with ankle brace
Arm Type
Experimental
Arm Description
This group will receive bilateral off-the-shelf ankle braces as well as a customized walking program.
Arm Title
Individualized walking program
Arm Type
Experimental
Arm Description
This group will receive a customized walking program.
Arm Title
Walking program with custom braces
Arm Type
Experimental
Arm Description
This group will receive bilateral custom-fabricated ankle braces as well as a customized walking program.
Intervention Type
Other
Intervention Name(s)
Walking program with ankle brace
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individualized walking program
Intervention Description
Walking program will include instructions on walking activities at home such as time of walking
Intervention Type
Other
Intervention Name(s)
Walking program with custom braces.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Distance Walked on 6-Minute Walk Test (6MWT)
Description
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 Outcome Measure Information:
Title
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Description
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
Other Pre-specified Outcome Measures:
Title
Change in Daily Activity as Measured by Steps Per Day
Description
Participants will be asked to wear a pedometer for 7 days at designated times in study. Total steps per day will be recorded.
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
Age between 30 and 90.
Ability to walk 150 feet independently over level surfaces with or without an assistive device.
Hoehn and Yahr stage 1-4.
Less than 10 full heel raises in single limb stance bilaterally.
Adequate insurance/funding to pay for physical therapy evaluation and AFO devices.
Exclusion Criteria:
Body mass index greater than 40.
Passive dorsiflexion range of motion less than approximately neutral (90 degrees)
Any other uncontrolled health condition for which gait training is contraindicated
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J McCain, DPT
Organizational Affiliation
UTSW Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center David M. Crowley Research and Rehabilitation Laboratory
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Impact of Walking Practice on Persons With PD
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