Recruiting

Orthoses

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT07720700

Conditions

Ataxia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Home wearing schedule

Study Details

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.

Conditions

Ataxia

Study ID

NCT07720700

Start date

Nov 21, 2025

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Home wearing schedule

Participants will wear the orthoses at home and record the time

Primary outcome measure

  • Zeno Walkway [ Time Frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis. ]
  • Zeno Walkway [ Time Frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis. ]

Central Contacts and Locations

Central contacts

Staci M Shearin, PT, PhD

214-648-6564staci.shearin@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75235

Contacts

Staci M Shearin, PT, PhD

214-648-6564staci.shearin@utsw.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Jul 22, 2026

Last verified

Jul, 2026

Keywords

  • Ataxia
  • Orthoses
  • Gait

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-07-22.