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Bracing for Walking in Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03192046
Recruitment Status : Completed
First Posted : June 19, 2017
Last Update Posted : January 8, 2021
American Orthotic and Prosthetic Association
Information provided by (Responsible Party):
Staci Shearin, University of Texas Southwestern Medical Center

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.

Condition or disease Intervention/treatment Phase
Gait Disorders, Neurologic Parkinson Disease Device: Carbon Fiber Ankle Foot Orthosis (AFO) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, repeated measures, matched group study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD
Actual Study Start Date : September 2016
Actual Primary Completion Date : December 2020
Actual Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Carbon Fiber Ankle Foot Orthosis (AFO)
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.
Device: Carbon Fiber Ankle Foot Orthosis (AFO)
Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.

Active Comparator: Control Group, Walking Program Only
The participants in this group will be prescribed a daily home walking walking program and 7 visits of PT.
Device: Carbon Fiber Ankle Foot Orthosis (AFO)
Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.

Primary Outcome Measures :
  1. Change in 6 Minute Walk Test [ Time Frame: Initial and 6 months ]
    Self-selected velocity on level surface for six minutes.

Secondary Outcome Measures :
  1. Change in Four Square Step test [ Time Frame: Initial and 6 months ]
    Balance while stepping in different directions will be assessed using this test.

  2. Change in Computerized Gait Analysis [ Time Frame: Initial and 6 months ]
    Gait will be evaluated using the Observational Gait Analysis system during over ground walking

  3. Change in Three-Dimensional gait analysis [ Time Frame: Initial and 6 months ]
    Subjects will be outfitted with small retro-reflective markers secured to anatomical locations with easily removable tape

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03192046

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United States, Texas
UT Southwestern
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
American Orthotic and Prosthetic Association
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Principal Investigator: Staci Shearin, Masters UT Southwestern
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Responsible Party: Staci Shearin, Assistant Professor, University of Texas Southwestern Medical Center Identifier: NCT03192046    
Other Study ID Numbers: STU 012014-059
First Posted: June 19, 2017    Key Record Dates
Last Update Posted: January 8, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Parkinson Disease
Nervous System Diseases
Gait Disorders, Neurologic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Carbon Fiber
Anti-Infective Agents, Local
Anti-Infective Agents