Friedreich AtaxiaSTEP-OUT FANCT07731971
Digital Outcome Assessment Using AI Active Gaming and Motion Capture in Friedreich Ataxia
An observational study of Friedreich Ataxia, run by University of Exeter at 1 site in United Kingdom.
Trial summary
Friedreich ataxia (FA) is a rare, inherited condition that progressively affects balance, coordination, and walking. Clinical trials of new FA treatments rely largely on standard clinical rating scales, but these can be tiring for patients, feel disconnected from everyday life, and may not detect small but meaningful… Read more about this study
- Who is it for?
- Ages 12 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Friedreich Ataxia
- What is being tested?
- Laboratory validation session (VSimulator) and Home-based active gaming assessment
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Jul 2026to 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 12 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Study participants with FA spanning a range of disease severity and functional mobility, recruited across England, together with healthy volunteers of the same age range serving as a comparison group.
Who may be able to join
None listed.
Who cannot join
- Friedreich ataxia group:
- Aged 11 years or younger, or 51 years or older
- Severe cognitive impairment precluding task comprehension
- Active seizure disorder, or vestibular dysfunction causing nausea with non-immersive VR
- Currently participating in an interventional clinical trial
- No reliable internet connection (where a digital inclusion pack cannot resolve this)
Show all 11Show fewer
- Any reason precluding safe participation in moderate-intensity exercise.
- Healthy control group:
- Aged 11 years or younger, or 51 years or older
- Genetically confirmed Friedreich ataxia
- Any reason precluding safe participation in moderate-intensity exercise.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kim Chapman contact
United Kingdom1 site
University of Exeter
Exeter
Talita Dias da Silva Magalhaes, +44 (0) 1392 661000, t.dias.magalhaes@exeter.ac.uk
Kim L Chapman, k.chapman3@exeter.ac.uk
About this study
Official title: Fusion of Therapeutic AI Active Gaming With Motion Capture to Create a Novel Digital Clinical Outcome Assessment (dCOA) in Friedreich Ataxia
Friedreich ataxia (FA) is a rare, inherited condition that progressively affects balance, coordination, and walking. Clinical trials of new FA treatments rely largely on standard clinical rating scales, but these can be tiring for patients, feel disconnected from everyday life, and may not detect small but meaningful changes over time. More objective, sensitive, and patient-relevant ways of measuring movement are needed.
This study is developing and testing a new digital way of measuring movement in FA. Participants play short, movement-based computer games on a laptop while a single camera and artificial-intelligence (AI) software track how they move. The proposition is that the way a person plays these games - their speed, accuracy, and movement quality - can provide objective, meaningful measurements of motor function. In the laboratory, these game-based measurements are compared against a "gold-standard" full-body motion-capture system and against established clinical scales to check how accurate and meaningful they are.
Read more
The study involves both people with Friedreich ataxia (across a range of disease severity) and healthy volunteers. People with FA also take part in a 12-week home phase, playing the games at home each month with remote support, so the researchers can examine whether the digital measurements are reliable when repeated and whether they can detect change over time.
The study asks whether these digital, game-based movement measurements are reliable, valid, and sensitive enough to be used as a "fit-for-purpose" digital clinical outcome assessment (dCOA) in future FA clinical trials, and whether patients find the platform acceptable, usable, and relevant to daily life. This is an early-stage feasibility and validation study designed to establish proof of concept rather than to test the effectiveness of a treatment.
Read the detailed description
Design and rationale STEP-OUT FA is an observational, prospective cohort study (STROBE-compliant) developing and validating a digital clinical outcome assessment (dCOA) for Friedreich ataxia. It addresses a well-documented limitation in FA therapeutic development: existing semi-quantitative clinical outcome assessments are affected by floor and ceiling effects, limited responsiveness across disease stages, and poor patient-perceived relevance, which have contributed to repeated failures of drug trials to meet primary endpoints. The study evaluates whether motor-performance metrics captured during gamified, semi-immersive virtual-reality (VR) tasks, combined with markerless AI motion analysis, can serve as reliable, valid, and responsive outcome measures.
Measurement platform The platform is delivered through a standard laptop and integrates three components: (1) FA-adaptable VR gamified tasks (e.g., ball catching, target reaching) with adjustable difficulty; (2) automated extraction of gaming-performance metrics; and (3) a single-camera, patented AI-driven markerless motion-capture system for 3D pose reconstruction (DigiTherapix Ltd), used to derive biomechanical/kinematic metrics. The gaming environment is provided via the MoveHero platform (University of São Paulo).
Laboratory validation (healthy controls and FA participants) Validation is conducted at the University of Exeter VSimulator facility against a gold-standard, marker-based full-body motion-capture reference. During a single laboratory visit (~2 hours), participants complete a familiarisation period followed by a ~20-minute session of four movement-based gaming tasks. Concurrent signals are recorded throughout: full-body optical motion capture (reflective markers on shoulders, elbows, knees, ankles, forehead), continuous heart-rate variability via a Delsys ECG sensor (baseline, task, recovery), and functional near-infrared spectroscopy (fNIRS) over the forehead to index cortical activation. Perceived exertion and fatigue (Borg RPE and Borg VAS Fatigue) are collected after each task, and a short semi-structured interview captures usability and acceptability feedback (audio-recorded for later transcription). FA participants additionally complete clinical characterisation at baseline.
Home-based longitudinal phase (FA participants only) To evaluate test-retest reliability and responsiveness, FA participants enter a 12-week home phase with monthly self-administered or remotely supported gaming sessions (~20-30 minutes) at Weeks 4, 8, and 12, each accompanied by a brief telehealth check-in with a physiotherapist to confirm continued consent, provide support, and monitor adverse events. Data are captured automatically and remotely. A remote follow-up assessment at Week 12 repeats clinical and patient-reported measures and includes a short interview.
Analytic approach Concurrent validity is assessed via correlations between digital metrics and established clinical scales; reliability via intraclass correlation coefficients across repeated sessions; and responsiveness via within-subject change and effect sizes, with longitudinal mixed-effects modelling of dCOA trajectories across the home-phase time points. Analyses characterise which individual or composite metrics (gaming-derived versus biomechanical) show optimal measurement properties and best discriminate disease severity. As an exploratory feasibility and validation study establishing proof of concept and psychometric properties, no formal power calculation was performed; the sample size was justified on precision for reliability estimation and on precedent from rare-disease dCOA validation studies.
Collaborators and data governance The AI motion-analysis platform is provided by DigiTherapix Ltd (UK) and the gaming platform by the University of São Paulo (Brazil); formal sub-contractor and data-sharing agreements govern intellectual property and data governance. No personally identifiable participant data are transferred outside the UK. Oxford University Hospitals acts as a Participant Identification Centre only.
- Conditions
- Friedreich Ataxia
- Being tested
- Laboratory validation session (VSimulator), Home-based active gaming assessment
- Keywords
- digital clinical outcome assessment, markerless motion capture, artificial intelligence, active video gaming, virtual reality, motor performance, test-retest reliability, balance and coordination, rare disease
- Medical subject headings
- Friedreich Ataxia, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory validation session (VSimulator)Device
Single laboratory visit at the University of Exeter VSimulator in which VR active gaming tasks and single-camera AI-driven markerless motion analysis are performed concurrently with gold-standard marker-based full-body motion capture, functional near-infrared spectroscopy (fNIRS), and continuous heart-rate variability (Delsys ECG sensor). Performed once.
Home-based active gaming assessmentDevice
Monthly home-based sessions (Weeks 4, 8, 12) in which participants perform the VR active gaming tasks with concurrent single-camera AI-driven markerless motion analysis via a loaned laptop, with automated remote data capture. No marker-based motion capture, fNIRS, or ECG.
| Study group | Role | What they receive |
|---|---|---|
| Friedreich Ataxia | Participants aged 12-50 with genetically confirmed FA (homozygous GAA expansion or compound heterozygous FXN mutations). Complete the laboratory validation session and a 12-week home-based phase with monthly gaming sessions. Receives: Device: Laboratory validation session (VSimulator); Device: Home-based active gaming assessment | |
| Healthy Controls | Participants aged 12-50 without FA, providing reference data for validation. Complete the laboratory validation session only. Receives: Device: Laboratory validation session (VSimulator) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concurrent validity of game-based movement performance against the mFARS - Friedreich ataxia cohort.
Spearman correlation coefficient (ρ; unitless) between game-based movement accuracy (Absolute Error), precision (Variable Error), reaction time, movement time and the modified Friedreich's Ataxia Rating Scale (mFARS) total score (range 0-93; higher = greater neurological impairment), in the Friedreich ataxia cohort.
Measured: Baseline laboratory visit (Week 0)
Criterion validity of AI markerless motion capture versus marker-based motion capture - Healthy Controls and Friedreich Ataxia
Agreement for upper and lower body angular velocity, joint angles and functional range of motion measured concurrently by the single-camera AI markerless system and the gold-standard marker-based motion-capture system.
Measured: Baseline laboratory visit (Week 0)
Comparison of the digital COA metrics between healthy control and Friedreich ataxia cohort.
Use of VR game-derived digital metrics (reaction time, movement time, movement accuracy and precision, and AI-derived kinematic metrics such as angular velocity, joint angles and Functional Range of Motion) to compare healthy control and Friedreich ataxia cohort.
Measured: Baseline laboratory visit (Week 0)
Responsiveness of digital COA metrics over time
Within-subject change scores and effect sizes for digital metrics, analysed with longitudinal mixed-effects modelling of dCOA trajectories across the home-based phase.
Measured: Weeks 0, 4, 8, and 12
Patient Global Impression of Change (PGIC)
Patient Global Impression of Change, 7-point ordinal scale (1 = very much improved to 7 = very much worse; higher = greater perceived worsening), in the FA cohort.
Measured: Week 12
Platform acceptability and usability
System Usability Scale (SUS) total score (range 0-100; higher = better usability; ≥70 acceptable, ≥80 excellent).
Measured: Weeks 0, 4, 8, and 12
Secondary outcomes (6)
Cortical activation during gaming tasks (fNIRS) - healthy control and Friedreich ataxia cohort.
Changes in cortical haemodynamic response (oxygenated and deoxygenated haemoglobin) measured by functional near-infrared spectroscopy during the gaming session.
Measured: Baseline laboratory visit (Week 0)
Autonomic response during gaming tasks (heart-rate variability) - healthy control and Friedreich ataxia cohort.
Heart-rate variability indices derived from continuous ECG recording (Delsys sensor) at baseline, during, and after the gaming session.
Measured: Baseline laboratory visit (Week 0)
Perceived exertion (Borg CR10) - healthy control and Friedreich ataxia cohort.
Borg Rating of Perceived Exertion score (range 1-10; higher = greater exertion) after each gaming task.
Measured: Baseline laboratory visit (Week 0)
Fatigue (Borg VAS Fatigue) - healthy control and Friedreich ataxia cohort.
Visual Analogue Scale (VAS) for fatigue (range 0-10; higher = greater fatigue) after each gaming task.
Measured: Baseline laboratory visit (Week 0)
9-Hole Peg Test completion time - healthy control and Friedreich ataxia cohort.
Time to complete the 9-Hole Peg Test (9HPT), measured in seconds (higher = worse manual dexterity; no fixed maximum), averaged across the dominant and non-dominant hands, in the Friedreich ataxia cohort.
Measured: Baseline laboratory visit (Week 0)
Gait quality: proportion of good steps (Heel2Toe sensor)
Proportion of "good steps" - steps in which the heel strikes first, detected by the Heel2Toe wearable sensor from ankle sagittal-plane angular velocity, expressed as a percentage of total steps taken during a standardised walking task (range 0-100%; higher = better gait quality), in the Friedreich ataxia cohort.
Measured: Baseline laboratory visit (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- 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 Friedreich AtaxiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Exeter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Helen Dawes, Principal investigator, University of ExeterAndrea Nemeth, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07731971
- Sponsor's protocol ID
- STEP-OUT-FA-364818
- Other IDs
- RMC 25-04, 364818, 25-26-27
- Acronym
- STEP-OUT FA
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 28 Jul 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 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fusion of Therapeutic AI Active Gaming With Motion Capture to Create a Novel Digital Clinical Outcome Assessment (dCOA) in Friedreich Ataxia
- ClinicalTrials.gov ID
- NCT07731971
- Acronym / sponsor ID
- STEP-OUT FA / STEP-OUT-FA-364818
- Conditions
- Friedreich Ataxia
- Keywords
- digital clinical outcome assessment, markerless motion capture, artificial intelligence, active video gaming, virtual reality, motor performance, test-retest reliability, balance and coordination
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of ExeterUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 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.
Friedreich ataxia (FA) is a rare, inherited condition that progressively affects balance, coordination, and walking. Clinical trials of new FA treatments rely largely on standard clinical rating scales, but these can be tiring for patients, feel disconnected from everyday life, and may not detect small but meaningful changes over time. More objective, sensitive, and patient-relevant ways of measuring movement are needed.
This study is developing and testing a new digital way of measuring movement in FA. Participants play short, movement-based computer games on a laptop while a single camera and artificial-intelligence (AI) software track how they move. The proposition is that the way a person plays these games - their speed, accuracy, and movement quality - can provide objective, meaningful measurements of motor function. In the laboratory, these game-based measurements are compared against a "gold-standard" full-body motion-capture system and against established clinical scales to check how accurate and meaningful they are.
The study involves both people with Friedreich ataxia (across a range of disease severity) and healthy volunteers. People with FA also take part in a 12-week home phase, playing the games at home each month with remote support, so the researchers can examine whether the digital measurements are reliable when repeated and whether they can detect change over time.
The study asks whether these digital, game-based movement measurements are reliable, valid, and sensitive enough to be used as a "fit-for-purpose" digital clinical outcome assessment (dCOA) in future FA clinical trials, and whether patients find the platform acceptable, usable, and relevant to daily life. This is an early-stage feasibility and validation study designed to establish proof of concept rather than to test the effectiveness of a treatment.
Detailed description
Design and rationale STEP-OUT FA is an observational, prospective cohort study (STROBE-compliant) developing and validating a digital clinical outcome assessment (dCOA) for Friedreich ataxia. It addresses a well-documented limitation in FA therapeutic development: existing semi-quantitative clinical outcome assessments are affected by floor and ceiling effects, limited responsiveness across disease stages, and poor patient-perceived relevance, which have contributed to repeated failures of drug trials to meet primary endpoints. The study evaluates whether motor-performance metrics captured during gamified, semi-immersive virtual-reality (VR) tasks, combined with markerless AI motion analysis, can serve as reliable, valid, and responsive outcome measures.
Measurement platform The platform is delivered through a standard laptop and integrates three components: (1) FA-adaptable VR gamified tasks (e.g., ball catching, target reaching) with adjustable difficulty; (2) automated extraction of gaming-performance metrics; and (3) a single-camera, patented AI-driven markerless motion-capture system for 3D pose reconstruction (DigiTherapix Ltd), used to derive biomechanical/kinematic metrics. The gaming environment is provided via the MoveHero platform (University of São Paulo).
Laboratory validation (healthy controls and FA participants) Validation is conducted at the University of Exeter VSimulator facility against a gold-standard, marker-based full-body motion-capture reference. During a single laboratory visit (~2 hours), participants complete a familiarisation period followed by a ~20-minute session of four movement-based gaming tasks. Concurrent signals are recorded throughout: full-body optical motion capture (reflective markers on shoulders, elbows, knees, ankles, forehead), continuous heart-rate variability via a Delsys ECG sensor (baseline, task, recovery), and functional near-infrared spectroscopy (fNIRS) over the forehead to index cortical activation. Perceived exertion and fatigue (Borg RPE and Borg VAS Fatigue) are collected after each task, and a short semi-structured interview captures usability and acceptability feedback (audio-recorded for later transcription). FA participants additionally complete clinical characterisation at baseline.
Home-based longitudinal phase (FA participants only) To evaluate test-retest reliability and responsiveness, FA participants enter a 12-week home phase with monthly self-administered or remotely supported gaming sessions (~20-30 minutes) at Weeks 4, 8, and 12, each accompanied by a brief telehealth check-in with a physiotherapist to confirm continued consent, provide support, and monitor adverse events. Data are captured automatically and remotely. A remote follow-up assessment at Week 12 repeats clinical and patient-reported measures and includes a short interview.
Analytic approach Concurrent validity is assessed via correlations between digital metrics and established clinical scales; reliability via intraclass correlation coefficients across repeated sessions; and responsiveness via within-subject change and effect sizes, with longitudinal mixed-effects modelling of dCOA trajectories across the home-phase time points. Analyses characterise which individual or composite metrics (gaming-derived versus biomechanical) show optimal measurement properties and best discriminate disease severity. As an exploratory feasibility and validation study establishing proof of concept and psychometric properties, no formal power calculation was performed; the sample size was justified on precision for reliability estimation and on precedent from rare-disease dCOA validation studies.
Collaborators and data governance The AI motion-analysis platform is provided by DigiTherapix Ltd (UK) and the gaming platform by the University of São Paulo (Brazil); formal sub-contractor and data-sharing agreements govern intellectual property and data governance. No personally identifiable participant data are transferred outside the UK. Oxford University Hospitals acts as a Participant Identification Centre only.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Friedreich Ataxia | – | Device: Laboratory validation session (VSimulator), Device: Home-based active gaming assessmentParticipants aged 12-50 with genetically confirmed FA (homozygous GAA expansion or compound heterozygous FXN mutations). Complete the laboratory validation session and a 12-week home-based phase with monthly gaming sessions. |
| Healthy Controls | – | Device: Laboratory validation session (VSimulator)Participants aged 12-50 without FA, providing reference data for validation. Complete the laboratory validation session only. |
Who may qualify
- Ages
- 12 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study participants with FA spanning a range of disease severity and functional mobility, recruited across England, together with healthy volunteers of the same age range serving as a comparison group.
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Friedreich ataxia group:
- Aged 11 years or younger, or 51 years or older
- Severe cognitive impairment precluding task comprehension
- Active seizure disorder, or vestibular dysfunction causing nausea with non-immersive VR
- Currently participating in an interventional clinical trial
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 |
|---|---|---|
| Laboratory validation session (VSimulator)Single laboratory visit at the University of Exeter VSimulator in which VR active gaming tasks and single-camera AI-driven markerless motion analysis are performed concurrently with gold-standard marker-based full-body motion capture, functional near-infrared spectroscopy (fNIRS), and continuous heart-rate variability (Delsys ECG sensor). Performed once. | Device | Friedreich Ataxia, Healthy Controls |
| Home-based active gaming assessmentMonthly home-based sessions (Weeks 4, 8, 12) in which participants perform the VR active gaming tasks with concurrent single-camera AI-driven markerless motion analysis via a loaned laptop, with automated remote data capture. No marker-based motion capture, fNIRS, or ECG. | Device | Friedreich Ataxia |
Primary outcome
Concurrent validity of game-based movement performance against the mFARS - Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Spearman correlation coefficient (ρ; unitless) between game-based movement accuracy (Absolute Error), precision (Variable Error), reaction time, movement time and the modified Friedreich's Ataxia Rating Scale (mFARS) total score (range 0-93; higher = greater neurological impairment), in the Friedreich ataxia cohort.
Criterion validity of AI markerless motion capture versus marker-based motion capture - Healthy Controls and Friedreich Ataxia
Time frame: Baseline laboratory visit (Week 0)
Agreement for upper and lower body angular velocity, joint angles and functional range of motion measured concurrently by the single-camera AI markerless system and the gold-standard marker-based motion-capture system.
Comparison of the digital COA metrics between healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Use of VR game-derived digital metrics (reaction time, movement time, movement accuracy and precision, and AI-derived kinematic metrics such as angular velocity, joint angles and Functional Range of Motion) to compare healthy control and Friedreich ataxia cohort.
Responsiveness of digital COA metrics over time
Time frame: Weeks 0, 4, 8, and 12
Within-subject change scores and effect sizes for digital metrics, analysed with longitudinal mixed-effects modelling of dCOA trajectories across the home-based phase.
Patient Global Impression of Change (PGIC)
Time frame: Week 12
Patient Global Impression of Change, 7-point ordinal scale (1 = very much improved to 7 = very much worse; higher = greater perceived worsening), in the FA cohort.
Platform acceptability and usability
Time frame: Weeks 0, 4, 8, and 12
System Usability Scale (SUS) total score (range 0-100; higher = better usability; ≥70 acceptable, ≥80 excellent).
6 secondary outcomes
Cortical activation during gaming tasks (fNIRS) - healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Autonomic response during gaming tasks (heart-rate variability) - healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Perceived exertion (Borg CR10) - healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Fatigue (Borg VAS Fatigue) - healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
9-Hole Peg Test completion time - healthy control and Friedreich ataxia cohort.
Time frame: Baseline laboratory visit (Week 0)
Gait quality: proportion of good steps (Heel2Toe sensor)
Time frame: Baseline laboratory visit (Week 0)
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 28 Jul 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.
Kim Chapman contact
Helen Dawes principal investigator
University of Exeter
Andrea Nemeth study director
University of Oxford
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 Friedreich Ataxia, run by University of Exeter at 1 site in United Kingdom.
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 0 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 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 Kingdom. 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 Talita Dias da Silva Magalhaes (+44 (0) 1392 661000, t.dias.magalhaes@exeter.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concurrent validity of game-based movement performance against the mFARS - Friedreich ataxia cohort. (time frame: Baseline laboratory visit (Week 0)). The study lists 6 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 28 Jul 2026.