Back to resultsEffect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ankle foot orthosis
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, ankle foot orthosis (AFO), gait
Eligibility Criteria
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
Sites / Locations
- UT Southwestern Medical Center, School of Health Professions
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Ankle foot orthosis fitting
Arm Description
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01798927
First Posted
February 11, 2013
Last Updated
July 6, 2015
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01798927
Brief Title
Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
Official Title
Investigation of Lower Extremity Orthoses on Gait in Persons With Parkinson's Disease: a Case Series.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Why Stopped
Modifications are being made to protocol
Study Start Date
December 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (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 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
Parkinson's disease, ankle foot orthosis (AFO), gait
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ankle foot orthosis fitting
Arm Type
Other
Arm Description
All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.
Intervention Type
Device
Intervention Name(s)
Ankle foot orthosis
Other Intervention Name(s)
Tamarack with check strap
Intervention Description
Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
Primary Outcome Measure Information:
Title
Change in Step Length by Means of Computerized Gait Analysis From Initial to Final Testing
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 step length.
Time Frame
Done at time of enrollment in the study, i.e. baseline and 10 weeks post enrollment
Secondary Outcome Measure Information:
Title
Number of Participants With a Change in Electromyography of Key Lower Extremity Muscles From Initial to Final Testing
Description
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.
Other Pre-specified Outcome Measures:
Title
Change in Walking Endurance by Use of 6-Minute Walk Test From Initial to Final Testing
Description
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.
Time Frame
Done at time of enrollment in the study, i.e. baseline and week 10 post enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
UT Southwestern Medical Center, School of Health Professions
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
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