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NCT07720700NARecruiting

Impact of Foot Orthoses on Gait in Individuals With Ataxia

University of Texas Southwestern Medical Center

Start Date

11/21/2025

Completion Date

12/1/2027

Summary

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.

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

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Home wearing schedule

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Conditions

Ataxia

Locations

UT Southwestern Medical Center

Dallas, Texas 75235

United States