Impact of Foot Orthoses on Gait in Individuals With Ataxia
Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses
1 other identifier
interventional
20
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 21, 2025
CompletedFirst Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
July 22, 2026
July 1, 2026
2 years
June 23, 2026
July 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Zeno Walkway
This is kinematic gait information including gait velocity.
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.
Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Secondary Outcomes (2)
6 MWT
Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Quebec User Evaluation of Satisfaction with Assistive Technology (survey)
After 14 days after wearing the orthosis.
Study Arms (2)
Custom orthoses
EXPERIMENTALSupramalleolar 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.
Off the shelf
EXPERIMENTALCarbon 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.
Interventions
Participants will wear the orthoses at home and record the time
Eligibility Criteria
You may qualify if:
- Cerebellar ataxia diagnosed by a physician
- Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
- years or older
You may not qualify if:
- Gait velocity \>/= 100 cm/sec without an assistive device
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
- Unhealed wounds on the feet
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UT Southwestern Medical Center
Dallas, Texas, 75235, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 23, 2026
First Posted
July 22, 2026
Study Start
November 21, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
July 22, 2026
Record last verified: 2026-07