Digital Outcome Assessment Using AI Active Gaming and Motion Capture in Friedreich 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

Qualifiers

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 design

Treatments tested in this trial

  • Laboratory validation session (VSimulator)
  • Home-based active gaming assessment

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Exeter

Lead sponsor

University of Oxford

Collaborator