N/A
N=9
Bracing for Walking in Parkinson's Disease
Gait Disorders, Neurologic · Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03192046 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Mar 2022
Primary outcome: Primary: Change in Gait Capacity as Assessed b 6-Minute Walk Test — 235.7; 150.0 Feet
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Carbon Fiber Ankle Foot Orthosis (AFO) (Device); Standardized walking/exercise program (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Gait Capacity as Assessed b 6-Minute Walk Test |
235.7; 150.0 | — |
| SECONDARY Change in Step Length |
4.0; 0.7 | — |
| SECONDARY Change in Temporal Spatial Gait Parameters Using the Computerized Gait Analysis System |
21.7; 6.26 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03192046). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.