AtaxiaNCT07720700
Impact of Foot Orthoses on Gait in Individuals With Ataxia
A study testing Home wearing schedule in people with Ataxia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ataxia
- What is being tested?
- Home wearing schedule
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebellar ataxia diagnosed by a physician
- Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
- 18 years or older
Who cannot join
- Gait velocity >/= 100 cm/sec without an assistive device
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
- Unhealed wounds on the feet
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center
Dallas, Texas, 75235
Staci M Shearin, PT, PhD, 214-648-6564, staci.shearin@utsw.edu
About this study
Official title: 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.
Read the 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
- Conditions
- Ataxia
- Being tested
- Home wearing schedule
- Keywords
- Ataxia, Orthoses, Gait
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home wearing scheduleDevice
Participants will wear the orthoses at home and record the time
| Study group | Role | What they receive |
|---|---|---|
| Custom orthoses | Experimental | 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. Receives: Device: Home wearing schedule |
| Off the shelf | Experimental | 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. Receives: Device: Home wearing schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zeno Walkway
This is kinematic gait information including gait velocity.
Measured: 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.
Measured: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Secondary outcomes (2)
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.
Measured: 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.
Measured: After 14 days after wearing the orthosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start21 Nov 2025
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtaxiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Wilson, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720700
- Sponsor's protocol ID
- STU-2020-0059
- Status last verified
- Jul 2026
- First submitted
- 23 Jun 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Functional Performance in Patients With Lower Limb Orthoses
- ClinicalTrials.gov ID
- NCT07720700
- Acronym / sponsor ID
- STU-2020-0059
- Conditions
- Ataxia
- Keywords
- Ataxia, Orthoses, Gait
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 21 Nov 2025 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Custom orthoses | Experimental | Device: Home wearing scheduleSupramalleolar 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 | Experimental | Device: Home wearing scheduleCarbon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cerebellar ataxia diagnosed by a physician
- Ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s)
- 18 years or older
Key exclusion criteria (3 listed)
- Gait velocity >/= 100 cm/sec without an assistive device
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
- Unhealed wounds on the feet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home wearing scheduleParticipants will wear the orthoses at home and record the time | Device | Custom orthoses, Off the shelf |
Primary outcome
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.
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.
2 secondary outcomes
6 MWT
Time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.
Quebec User Evaluation of Satisfaction with Assistive Technology (survey)
Time frame: After 14 days after wearing the orthosis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home wearing schedule in people with Ataxia, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Staci M Shearin, PT, PhD (214-648-6564, staci.shearin@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zeno Walkway (time frame: Day one (baseline) of receiving the orthosis then at 14 days after wearing the orthosis.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.