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Bracing for Walking in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03192046
Recruitment Status : Recruiting
First Posted : June 19, 2017
Last Update Posted : March 16, 2020
Sponsor:
Collaborator:
American Orthotic and Prosthetic Association
Information provided by (Responsible Party):
Staci Shearin, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE June 13, 2017
First Posted Date  ICMJE June 19, 2017
Last Update Posted Date March 16, 2020
Actual Study Start Date  ICMJE September 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
Change in 6 Minute Walk Test [ Time Frame: Initial and 6 months ]
Self-selected velocity on level surface for six minutes.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
  • Change in Four Square Step test [ Time Frame: Initial and 6 months ]
    Balance while stepping in different directions will be assessed using this test.
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bracing for Walking in Parkinson's Disease
Official Title  ICMJE Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Gait Disorders, Neurologic
  • Parkinson Disease
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.
    Intervention: Device: Carbon Fiber Ankle Foot Orthosis (AFO)
  • 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.
    Intervention: Device: Carbon Fiber Ankle Foot Orthosis (AFO)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 14, 2017)
16
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Staci Shearin, Masters 2146486564 staci.shearin@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03192046
Other Study ID Numbers  ICMJE STU 012014-059
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Staci Shearin, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE American Orthotic and Prosthetic Association
Investigators  ICMJE
Principal Investigator: Staci Shearin, Masters UT Southwestern
PRS Account University of Texas Southwestern Medical Center
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP