[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649245":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":37,"locations":46,"responsibleParty":61,"collaborators":63,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":73,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":10,"studyType":80,"phases":10,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":93,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Exeter","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Friedreich Ataxia",null,"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.",[13,14],"Device: Laboratory validation session (VSimulator)","Device: Home-based active gaming assessment",{"label":16,"type":10,"description":17,"interventionNames":18},"Healthy Controls","Participants aged 12-50 without FA, providing reference data for validation. Complete the laboratory validation session only.",[13],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","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.",[9,16],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Home-based active gaming assessment","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.",[9],[30,33],{"name":31,"affiliation":5,"role":32},"Helen Dawes","PRINCIPAL_INVESTIGATOR",{"name":34,"affiliation":35,"role":36},"Andrea Nemeth","University of Oxford","STUDY_DIRECTOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Talita Dias da Silva Magalhaes","CONTACT","+44 (0) 1392 661000","t.dias.magalhaes@exeter.ac.uk",{"name":44,"role":40,"phone":10,"phoneExt":10,"email":45},"Kim Chapman","k.chapman3@exeter.ac.uk",[47],{"facility":5,"status":10,"city":48,"state":10,"zip":10,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Exeter","United Kingdom","UK",{"type":52,"coordinates":53},"Point",[54,55],-3.52751,50.7236,{"lat":55,"lon":54},[58,59],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},{"name":60,"role":40,"phone":10,"phoneExt":10,"email":45},"Kim L Chapman",{"type":62,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[64],{"name":35,"class":6},"100649245","digital-outcome-assessment-using-ai-active-gaming-and-motion-capture-in-friedreich-ataxia-100649245",false,"NCT07731971","Digital Outcome Assessment Using AI Active Gaming and Motion Capture in Friedreich Ataxia","Fusion of Therapeutic AI Active Gaming With Motion Capture to Create a Novel Digital Clinical Outcome Assessment (dCOA) in Friedreich Ataxia","STEP-OUT FA","Friedreich ataxia group:\n\n* Aged 12 to 50 years\n* Genetically confirmed Friedreich ataxia\n* Able to sit or stand independently for 5 minutes\n* Able to provide informed consent (or assent with parental consent if under 16 years)\n* Stable medication regimen (no changes in the past 4 weeks)\n\nHealthy control group:\n\n* Aged 12 to 50 years\n* No history of genetically confirmed Friedreich ataxia\n* Able to sit or stand independently for 5 minutes\n* Able to provide informed consent (or assent with parental consent if under 16 years)\n\nExclusion Criteria:\n\n* Friedreich ataxia group:\n* Aged 11 years or younger, or 51 years or older\n* Severe cognitive impairment precluding task comprehension\n* Active seizure disorder, or vestibular dysfunction causing nausea with non-immersive VR\n* Currently participating in an interventional clinical trial\n* No reliable internet connection (where a digital inclusion pack cannot resolve this)\n* Any reason precluding safe participation in moderate-intensity exercise.\n\nHealthy control group:\n\n* Aged 11 years or younger, or 51 years or older\n* Genetically confirmed Friedreich ataxia\n* Any reason precluding safe participation in moderate-intensity exercise.",true,"ALL","12 Years","50 Years",{"count":78,"type":79},40,"ESTIMATED","OBSERVATIONAL","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.\n\nThis 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.\n\nThe 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.\n\nThe 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.",[9],[84,85,86,87,88,89,90,91,92],"digital clinical outcome assessment","markerless motion capture","artificial intelligence","active video gaming","virtual reality","motor performance","test-retest reliability","balance and coordination","rare disease","NOT_YET_RECRUITING","2026-07-22",{"date":96,"type":97},"2026-07-28","ACTUAL",{"date":99,"type":79},"2026-07-30",{"date":101,"type":79},"2026-12-31",{"name":5,"class":6},1]