Effect of Lower Extremity Ankle Foot Orthoses in Parkinson's Disease
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About
The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with Tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG) and walking endurance, in select individuals living with Parkinson's disease.
Full description
This study will be 10 weeks long. Following fitting with unilateral or bilateral custom-fabricated AFOs the subject will participate in 4 gait training sessions which will be at weeks 1, 2, and 7. Each training session will be 45-60 minutes in duration. Various outcome measures will be completed at the following times: time of consent (T1), treatment 1 at time of brace delivery (T2), week 5 (T3), and week 10 (T4). Subjects will be closely monitored throughout the 10 week study and will be unenrolled by self-request or the following medical reasons: 1. New diagnosis with direct consequences affecting gait training, 2. Inability to tolerate the study AFO(s).
Enrollment
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Volunteers
Inclusion criteria
- Confirmed diagnosis of Parkinson's Disease
- Between the ages of 50 and 75
- Ability to walk 150 feet independently over level surfaces with or without an assistive device
- Stable medication usage for the duration of the study (10 weeks)
- Obvious gait dysfunction (Observational Gait Analysis)
- Score of greater than 22 on the Short Orientation-Memory-Concentration Test
Exclusion criteria
- Body mass index of greater than 35
- Dorsiflexion range of motion less than neutral (90 degrees)
- Any other uncontrolled health condition for which gait training is contraindicated
Trial design
Primary purpose
Allocation
Interventional model
Masking
4 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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