An interventional study of Home wearing schedule in Ataxia, sponsored by University of Texas Southwestern Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Treatment
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.
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
Exclusion Criteria:
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.
Device: Home wearing schedule
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.
Device: Home wearing schedule
Participants will wear the orthoses at home and record the time
Zeno Walkway
This is kinematic gait information including gait velocity.
Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Zeno Walkway
This measures kinematic data such as step length.
Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
6 MWT
This test measures submaximal aerobic functional walking capacity. Each participant will be asked to walk at a self-selected velocity on level surfaces for 6 minutes.
Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Quebec User Evaluation of Satisfaction with Assistive Technology (survey)
This is a self-reported outcome measure that will be done at the last testing time point to assess participant considerations (ease of use for device, participant observations, perceived improvements in QOL). A higher score indicates higher levels of satisfaction.
Time frame: After 14 days after wearing the orthosis.
Plan to share: Undecided
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University of Texas Southwestern Medical Center