Impact of Foot Orthoses on Gait in Individuals With Ataxia

Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses

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.

Study Overview

• Status: Recruiting
• Conditions: Ataxia
• Intervention / Treatment: Device: Home wearing schedule

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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Staci M Shearin, PT, PhD; Phone Number: 214-648-6564; Email: staci.shearin@utsouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Staci M Shearin, PT, PhD; Phone Number: 214-648-6564; Email: staci.shearin@utsw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Device: Home wearing schedule; Participants will wear the orthoses at home and record the time
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.	Device: Home wearing schedule; Participants will wear the orthoses at home and record the time

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	After 14 days after wearing the orthosis.

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: June 23, 2026
• First Submitted That Met QC Criteria: July 16, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 16, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Gait; Orthoses; Ataxia
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Ataxia
• Other Study ID Numbers: STU-2020-0059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No