Spinocerebellar AtaxiaNCT06628934
Wearable Gait Sensors
An observational study of Spinocerebellar Ataxia, run by University of Chicago at 1 site in United States.
Trial summary
This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinocerebellar Ataxia
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2017to 31 Dec 2026
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of Ataxia Clinics
Who may be able to join
- Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.
- Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.
Who cannot join
- Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Wearable Sensors for Quantitation of Impaired Gait and Balance
This research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.
Read the detailed description
Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.
- Conditions
- Spinocerebellar Ataxia
- Medical subject headings
- Spinocerebellar Ataxias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Spinocerebellar Ataxia | Individuals with genetically-confirmed diagnosis of SCA | |
| Healthy Controls | Healthy Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
iSARA
Digital measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA).
Measured: 8 Years
Secondary outcomes (3)
Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)
Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The PROM-Ataxia is a 70-item assessment of physical, mental health, and activities of daily living, each scored on a 0-4 Likert scale. Scores are totaled.
Measured: 8 Years
Activities-specific Balance Confidence (ABC) Scale
Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The ABC scale is a 16 item scale with a rating scale from 0 (no confidence) to 100 (complete confidence) in avoiding a fall. The score is determined by taking the average of all items.
Measured: 8 Years
EQ-5D-5L
Comparing patient-reported outcome measures evaluation of severity and progression to the measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA). The EQ-5D-5L is a 5 item descriptive system to describe current mobility, self-case, usual activities, pain/discomfort, and anxiety/depression.
Measured: 8 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start23 Jun 2017
- Primary completion31 Dec 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06628934
- Sponsor's protocol ID
- IRB17-0253
- Status last verified
- Feb 2026
- First submitted
- 3 Oct 2024
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearable Sensors for Quantitation of Impaired Gait and Balance
- ClinicalTrials.gov ID
- NCT06628934
- Acronym / sponsor ID
- IRB17-0253
- Conditions
- Spinocerebellar Ataxia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 8 Oct 2024 (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 research study is testing body-worn sensors to measure movement during simple tests of coordination, in order to evaluate the progression and severity of Spinocerebellar ataxia.
Detailed description
Study participants will complete a neurological exam with sensors (iSARA exam) and three patient-reported questionnaires (PROM-Ataxia, ABC Scale, EQ-5D-5L). Participation will take about an hour.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinocerebellar Ataxia | – | –Individuals with genetically-confirmed diagnosis of SCA |
| Healthy Controls | – | –Healthy Controls |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of Ataxia Clinics
Key inclusion criteria (2 listed)
- Ataxia Group - Individuals who have a genetic-confirmation of SCA diagnosis and are able to sit or stand unassisted for 30 seconds and follow directions.
- Healthy Control Group - Individuals who are able to sit or stand unassisted for 30 seconds and follow directions.
Key exclusion criteria (1 listed)
- Any other neurological or musculoskeletal disorder not attributed to the SCA that could affect balance, gait or voluntary movement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
iSARA
Time frame: 8 Years
Digital measurements collected by wearable inertial sensors during instrumented Scale for the Assessment and Rating of Ataxia (iSARA).
3 secondary outcomes
Patient Reported Outcome Measure of Ataxia (PROM-Ataxia)
Time frame: 8 Years
Activities-specific Balance Confidence (ABC) Scale
Time frame: 8 Years
EQ-5D-5L
Time frame: 8 Years
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 5 Feb 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinocerebellar Ataxia, run by University of Chicago 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 2 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 5 Feb 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?
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?
iSARA (time frame: 8 Years). 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 5 Feb 2026.