Digital Outcome Assessment Using AI Active Gaming and Motion Capture in Friedreich Ataxia
ConditionFriedreich Ataxia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-50
SponsorUniversity of Exeter
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 12 to 50 years
Genetically confirmed Friedreich ataxia
Able to sit or stand independently for 5 minutes
Able to provide informed consent (or assent with parental consent if under 16 years)
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Laboratory validation session (VSimulator)
DeviceSingle 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 assessment
DeviceMonthly 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Friedreich Ataxia2 interventions
Group B: Healthy Controls1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline laboratory visit (Week 0)2
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.
Time frame
Baseline laboratory visit (Week 0)3
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.
Time frame
Baseline laboratory visit (Week 0)4
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.
Time frame
Weeks 0, 4, 8, and 12Secondary outcomes
1
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.
Time frame
Baseline laboratory visit (Week 0)2
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.
Time frame
Baseline laboratory visit (Week 0)3
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.
Time frame
Baseline laboratory visit (Week 0)4
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.
Time frame
Baseline laboratory visit (Week 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Exeter
Lead sponsor
University of Oxford
Collaborator
Source ClinicalTrials.gov
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