Bracing for Walking in Parkinson's Disease
Condition: Gait Disorders, Neurologic; Parkinson Disease
MeSH terms: Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

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.
    

Intervention name(s): Carbon Fiber Ankle Foot Orthosis (AFO); Standardized walking/exercise program
Intervention type(s): Device; Other
Intervention description(s): Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.; standardized walking/exercise program without any brace or AFO
Intervention MeSH terms: Carbon Fiber
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