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NCT Number: NCT07720700

Impact of Foot Orthoses on Gait in Individuals With Ataxia

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.

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Key information

Conditions

Ataxia Dyskinesias Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT Southwestern Medical Center

Dallas, Texas, 75235, United States

Location status: Recruiting

Location contact

Staci M Shearin, PT, PhD

CONTACT

[email protected]

214-648-6564

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Home wearing schedule

Device

Participants will wear the orthoses at home and record the time

Primary outcomes

  1. Zeno Walkway

    Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.

    This is kinematic gait information including gait velocity.

  2. Zeno Walkway

    Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.

    This measures kinematic data such as step length.

Secondary outcomes

  1. 6 MWT

    Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.

    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.

  2. Quebec User Evaluation of Satisfaction with Assistive Technology (survey)

    Time frame: After 14 days after wearing the orthosis.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Staci M Shearin, PT, PhD

CONTACT

[email protected]

214-648-6564

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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