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Bracing for Walking in Parkinson's Disease

Primary Purpose

Gait Disorders, Neurologic, Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Carbon Fiber Ankle Foot Orthosis (AFO)
Standardized walking/exercise program
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gait Disorders, Neurologic

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Confirmed diagnosis of Parkinson's Disease according to the UK brain bank criteria.5
  2. Age between 30 and 85.
  3. Measurable decrement in gait velocity (between 35 and 15 percent below age-predicted norms for self-selected walking velocity) as measured by the 6 MWT
  4. Hoehn and Yahr stage 2-3.
  5. Less than 10 full heel raises in single limb stance bilaterally.

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
  4. Self-report of > 1 fall/month
  5. A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment

Sites / Locations

  • UT Southwestern

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Carbon Fiber Ankle Foot Orthosis (AFO)

Control Group, Walking Program Only

Arm Description

For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.

The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.

Outcomes

Primary Outcome Measures

Change in Gait Capacity as Assessed b 6-Minute Walk Test
The 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).

Secondary Outcome Measures

Change in Step Length
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.
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Each subject 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 gait parameters.

Full Information

First Posted
June 13, 2017
Last Updated
February 25, 2022
Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Orthotic and Prosthetic Association
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1. Study Identification

Unique Protocol Identification Number
NCT03192046
Brief Title
Bracing for Walking in Parkinson's Disease
Official Title
Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 2020 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
American Orthotic and Prosthetic Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Parkinson disease (PD) is a progressive neurological disease that results in characteristic gait dysfunction. Gait problems include decreased velocity, decreased stride length, difficulty with initiation of gait, postural stability problems and alteration in joint kinematics.1 In this typically older patient population, these gait deviations affect their participation in household and community activities. The standard of care is currently focused on therapeutic exercise and cueing of various types (visual, auditory, verbal). Current interventions have not been demonstrated to markedly improve gait kinematics, so there is a need to identify interventions that could improve gait performance in this population. Lower extremity bracing is a common and well-established intervention for gait dysfunction with other populations, including stroke and brain injury. The braces allow for improved stability, sensory feedback, and consistent tactile cues to allow patients to have the best gait mechanics with each step. It is reasonable to hypothesize that appropriate bracing may have the potential to improve gait function and kinematics in PD since these patient often have gastroc-soleus weakness. Data from our early pilot studies indicates that bracing individuals with PD can positively impact their mobility. This includes improvements in velocity, step length, and dynamic balance. Additional data supported an upward trend in quality of life.
Detailed Description
This is a randomized, repeated measures, matched group study. There will be two groups of participants, 8 participants per group, 35 participants total from time of initial enrollment in this study. Group one (G1) will receive bilateral custom braces and a standardized home walking/exercise program. Group two will receive the standardized walking/exercise program without any brace or AFO. Subjects will be randomized upon enrollment in the study. At the time of consent, random drawing from concealed envelopes with red, blue or green chips will be done to determine group assignment. Subjects will be recruited through the Clinical Center for Movement Disorders at UT Southwestern Medical Center where patients with PD receive routine evaluation and follow-up. Subjects will be followed for 6 months during this study and outcome measures will be collected 3 times over the course of the study. Subjects will be seen every 3 months for the duration of the study for testing as well as for other visits as noted in the table below. Participants will not need to have insurance benefits for initial physical therapy evaluation and for ankle braces. All subsequent visits to the Crowley gait lab for assessments and brace adjustment will be provided at no cost to the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gait Disorders, Neurologic, Parkinson Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized, repeated measures, matched group study.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbon Fiber Ankle Foot Orthosis (AFO)
Arm Type
Experimental
Arm Description
For the bracing group, the participants will wear custom fabricated carbon fiber braces in addition to participating in a daily walking program and 7 visits of PT.
Arm Title
Control Group, Walking Program Only
Arm Type
Active Comparator
Arm Description
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Intervention Type
Device
Intervention Name(s)
Carbon Fiber Ankle Foot Orthosis (AFO)
Intervention Description
Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
Intervention Type
Other
Intervention Name(s)
Standardized walking/exercise program
Intervention Description
standardized walking/exercise program without any brace or AFO
Primary Outcome Measure Information:
Title
Change in Gait Capacity as Assessed b 6-Minute Walk Test
Description
The 6 Minute Walk Test (6MWT) is a test of walking (gait) endurance and walking velocity and measures the distance a subject can walk indoors on a flat, hard surface in a period of 6 minutes, using assistive devices, as necessary. The test is a reliable and valid evaluation of functional exercise capacity and is used as a sub-maximal test of aerobic capacity and endurance. The test will be used to determine participant's gait efficiency at baseline and at 6 months. While the total distance covered during six minutes (6MWTD) is often used as the standard measurement of gait capacity (i.e., the maximum distance one can achieve), the endurance (i.e., ability to maintain speed over a prolonged time) can be inferred by the gait speed trajectory (GST) during the 6MW test (6MWGST).
Time Frame
Baseline and 6 months
Secondary Outcome Measure Information:
Title
Change in Step Length
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
Baseline and 6 months
Title
Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System
Description
Each subject 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 gait parameters.
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 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 85. Measurable decrement in gait velocity (between 35 and 15 percent below age-predicted norms for self-selected walking velocity) as measured by the 6 MWT Hoehn and Yahr stage 2-3. Less than 10 full heel raises in single limb stance bilaterally. 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 Self-report of > 1 fall/month A score of 11 or less on the Short Orientation-Memory-Concentration Test of Cognitive Impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Staci Shearin, Masters
Organizational Affiliation
UT Southwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Bracing for Walking in Parkinson's Disease

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