Impact of Foot Orthoses on Gait in Individuals With Ataxia
Purpose
This study is the first to assess the impact of lower extremity orthoses on gait and balance in individuals with CA. By investigating how orthoses influence mobility and stability, this research will provide critical data to inform clinical guidelines, improve patient care, and support evidence-based orthotic prescriptions for individuals with CA.
Condition
- Ataxia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Cerebellar ataxia diagnosed by a physician - Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s) - 18 years or older
Exclusion Criteria
- Gait velocity >/= 100 cm/sec without an assistive device - Medically diagnosed orthopedic conditions or injuries that impact ambulation - Unhealed wounds on the feet
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Custom orthoses |
Supramalleolar Orthoses - are made specifically for the participant and provide stability, proprioceptive feedback and mild position as it is designed to cover the foot and ankle up to the malleoli. |
|
|
Experimental Off the shelf |
Carbon Fiber Insert - this is an off the self shoe insert that provides stability and proprioceptive feedback and is placed in the shoe under the shoe insole. |
|
Recruiting Locations
Dallas, Texas 75235
More Details
- Status
- Recruiting
- Sponsor
- University of Texas Southwestern Medical Center
Detailed Description
This study is the first randomized controlled trial to evaluate the impact of orthoses on the gait and balance of individuals with ataxia. Prior studies have suggested that foot orthoses may provide stability to improve lower extremity mechanics2, 3 by potentially reducing degrees of freedom3 or by enhancing proprioceptive feedback12, 13, yet no clinical trials have systematically tested these effects in CA, a population with unique joint kinematics and sensory integration challenges. In general, there is a paucity of literature for individuals with CA.14 However, there are many neurologic diagnoses that find orthoses to be beneficial for balance,5, 15, 16 gait,17, 18 and functional mobility.19