Bracing for Walking in Parkinson's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Parkinsons Disease, Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 30 - 85 |
| Updated: | 2/1/2019 |
| Start Date: | September 2016 |
| End Date: | June 2020 |
| Contact: | Staci Shearin, Masters |
| Email: | staci.shearin@utsouthwestern.edu |
| Phone: | 2146486564 |
Impact of Carbon Fiber AFOs on Gait and Resulting Changes in Quality of Life Across Time in Persons With PD
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.
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.
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.
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.
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
We found this trial at
1
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