Ataxia - OtherNCT06866353
Assistive Devices and Gait in Persons With Ataxia
A study testing Walking with different walkers in people with Ataxia - Other, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this research study is to determine the effect of various assistive devices on gait quality and balance for individuals with cerebellar ataxia. You are being asked to be a participant in this study because your balance and walking function have been impacted by cerebellar ataxia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ataxia - Other
- What is being tested?
- Walking with different walkers
- 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
- 22 May 2025to 6 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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,
- gait impairment (gait velocity </= 110 cm/sec without an assistive device),
- ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s), 18 years or older
Who cannot join
- Gait velocity >/= 110 cm/sec without an assistive device,
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impacts on Quality of Ambulation Using Various Assistive Devices for Patients With Cerebellar Ataxia
The purpose of this research study is to determine the effect of various assistive devices on gait quality and balance for individuals with cerebellar ataxia. You are being asked to be a participant in this study because your balance and walking function have been impacted by cerebellar ataxia.
Read the detailed description
The literature for cerebellar ataxia does not encompass specific details on selecting assistive devices. Studies do indicate that providing assistive devices for trunk support may improve gait and stability in individuals with ataxia. However, there is no consensus on assistive device selection. In general, falls and instability are one of the primary factors impacting independence, safety, and functional mobility. Additionally, early literature has indicated that external cues may be very beneficial for gait in individuals with ataxia.
No focal literature on what device is best but many articles suggest using them
- Trunk instability = gait variability, wider BOS with walker is beneficial (Buckley, 2018; Kelly, 2016)
- Choosing the correct walking aid is important, canes to walkers and those with a heavy base to prevent retropulsion as well as all-terrain walkers (Stephen, 2019) Additionally, aerobic, balance, core/strengthening, gait interventions are utilized via physical therapy.
- Conditions
- Ataxia - Other
- Being tested
- Walking with different walkers
- Keywords
- ataxia, gait, balance, assistive device
- Medical subject headings
- Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking with different walkersDevice
Participants will walk across a computerized pressure sensor mat and complete a dynamic walking test with several different assistive devices (rolling walker, rollator with platform, and a gait trainer) and potentially with a metronome. During all testing, study physical therapists will guard participants to assure safety. In total, the study will require 1 visit to the School of Health Professions for 1-2 hours
| Study group | Role | What they receive |
|---|---|---|
| Gait with Walker | Experimental | Individuals with ataxia Receives: Device: Walking with different walkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Zeno Walkway - Gait Speed
The Zeno provides kinematic gait information including gait velocity.
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start22 May 2025
- Primary completion6 Sep 2025
- Study completion6 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ataxia - OtherStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staci Shearin, University of Texas Southwestern Medical Center
- Investigators
- Staci M Shearin, PhD, Principal investigator, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866353
- Sponsor's protocol ID
- STU20250055
- Status last verified
- Sep 2026
- First submitted
- 4 Mar 2025
- Last updated
- 28 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Buckley E, Mazza C, McNeill A. A systematic review of the gait characteristics associated with Cerebellar Ataxia. Gait Posture. 2018 Feb;60:154-163. doi: 10.1016/j.gaitpost.2017.11.024. Epub 2017 Dec 1.
PubMed 29220753
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts on Quality of Ambulation Using Various Assistive Devices for Patients With Cerebellar Ataxia
- ClinicalTrials.gov ID
- NCT06866353
- Acronym / sponsor ID
- STU20250055
- Conditions
- Ataxia - Other
- Keywords
- ataxia, gait, balance, assistive device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 22 May 2025 (actual)
- Primary completion
- 6 Sep 2025 (actual)
- Study completion
- 6 Sep 2025 (actual)
- First posted
- 10 Mar 2025 (actual)
- Results
- Posted 28 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to determine the effect of various assistive devices on gait quality and balance for individuals with cerebellar ataxia. You are being asked to be a participant in this study because your balance and walking function have been impacted by cerebellar ataxia.
Detailed description
The literature for cerebellar ataxia does not encompass specific details on selecting assistive devices. Studies do indicate that providing assistive devices for trunk support may improve gait and stability in individuals with ataxia. However, there is no consensus on assistive device selection. In general, falls and instability are one of the primary factors impacting independence, safety, and functional mobility. Additionally, early literature has indicated that external cues may be very beneficial for gait in individuals with ataxia.
No focal literature on what device is best but many articles suggest using them
- Trunk instability = gait variability, wider BOS with walker is beneficial (Buckley, 2018; Kelly, 2016)
- Choosing the correct walking aid is important, canes to walkers and those with a heavy base to prevent retropulsion as well as all-terrain walkers (Stephen, 2019) Additionally, aerobic, balance, core/strengthening, gait interventions are utilized via physical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait with Walker | Experimental | Device: Walking with different walkersIndividuals with ataxia |
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,
- gait impairment (gait velocity </= 110 cm/sec without an assistive device),
- ambulatory for 16 feet (Zeno mat) with assistance and without assistive device(s), 18 years or older
Key exclusion criteria (2 listed)
- Gait velocity >/= 110 cm/sec without an assistive device,
- Medically diagnosed orthopedic conditions or injuries that impact ambulation
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 |
|---|---|---|
| Walking with different walkersParticipants will walk across a computerized pressure sensor mat and complete a dynamic walking test with several different assistive devices (rolling walker, rollator with platform, and a gait trainer) and potentially with a metronome. During all testing, study physical therapists will guard participants to assure safety. In total, the study will require 1 visit to the School of Health Professions for 1-2 hours | Device | Gait with Walker |
Primary outcome
Zeno Walkway - Gait Speed
Time frame: Day one
The Zeno provides kinematic gait information including gait velocity.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29220753Buckley E, Mazza C, McNeill A. A systematic review of the gait characteristics associated with Cerebellar Ataxia. Gait Posture. 2018 Feb;60:154-163. doi: 10.1016/j.gaitpost.2017.11.024. Epub 2017 Dec 1.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Staci M Shearin, PhD principal investigator
UTSW
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking with different walkers in people with Ataxia - Other, 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 2 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: finished, as of the sponsor's last update on 28 Sep 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?
Yes. Results are posted in the registry (first posted 28 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Zeno Walkway - Gait Speed (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06866353, which also lists 1 linked publication.
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 28 Sep 2026.