[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635677":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":54,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":64,"acronym":18,"eligibilityCriteria":65,"healthyVolunteers":62,"sex":66,"minAge":67,"maxAge":18,"enrollmentInfo":68,"targetDuration":18,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Imperial College London","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exercise with real-time muscle biofeedback","EXPERIMENTAL","Participants randomised to the intervention arm will receive a standardised lab session on the use of the MMG-biofeedback belt and mobile application. A physiotherapist or trained researcher will demonstrate how to perform each exercise, correct belt positioning, app navigation, calibration procedures, and how to interpret the real-time muscle activation feedback.\n\nParticipants will be issued the MMG-biofeedback belt and app after training and will use the system throughout their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week. The app will provide real-time feedback on muscle activation, progress summaries and reminders. Participants are asked to carry on any other treatment as usual. Aside from routine data collection and belt troubleshooting, participants in the control group will not receive additional input from the research team.",[13],"Device: MMG-biofeedback belt",{"label":15,"type":16,"description":17,"interventionNames":18},"Exercise without biofeedback (waitlist control)","NO_INTERVENTION","Participants randomised to the control arm will receive a standardised lab session, whereby core strength and endurance measures are taken. A physiotherapist or trained researcher will demonstrate how to perform each exercise.\n\nParticipants will be issued with a booklet containing the exercise programme with exercise video links and are asked to perform their prescribed home-based exercise sessions for the full eight-week intervention period. Participants are asked to perform the exercise programme (20-30 mins) at least 5 times a week.\n\nNo MMG-biofeedback belt will be provided to this group, participants are asked to carry on any other treatment as usual. Aside from routine data collection, participants in the control group will not receive additional input from the research team.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","MMG-biofeedback belt","The intervention consists of a wearable belt incorporating mechanomyography (MMG) sensors to detect muscle activity in the abdominal and lower back regions, paired with a mobile application that provides real-time visual feedback on core muscle activation during exercise. The system is designed to guide users in engaging the correct muscles, improve exercise performance, and support adherence to a prescribed exercise programme during both supervised and home-based sessions.",[9],[26],"UPPITT",[28],{"name":29,"affiliation":5,"role":30},"Paul Bentley","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Reneira Seeamber Balaghee","CONTACT","+447496682750","r.seeamber18@imperial.ac.uk",{"name":29,"role":34,"phone":38,"phoneExt":18,"email":39},"+44 7969 570854","p.bentley@imperial.ac.uk",[41],{"facility":5,"status":42,"city":43,"state":18,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","London","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-0.12574,51.50853,{"lat":50,"lon":49},[53],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},{"type":55,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[57],{"name":58,"class":59},"Surrey Physio","UNKNOWN","100635677","motivating-core-muscle-exercises-with-wearable-sensors-haptics-and-interactive-gaming-100635677",false,"NCT07555795","Motivating Core-muscle Exercises With Wearable Sensors, Haptics and Interactive Gaming","Inclusion Criteria:\n\n1. Over the age of 18\n2. Non-specific LBP for at least 6 weeks in the past 12 months\n3. Pain 4\u002F10 on a visual analogue scale or more or Oswestry Disability Index over 20%\n\nExclusion Criteria:\n\n1. Serious spinal pathology (\"red flags\") such as:\n\n   * History of malignancy with new onset back pain suggestive of recurrence.\n   * Unexplained weight loss, fever, or systemic symptoms.\n   * Recent significant trauma (e.g., fall from height, road traffic accident).\n   * Suspected or confirmed spinal infection (e.g., discitis, osteomyelitis).\n   * Cauda equina symptoms, including urinary retention\u002Fincontinence or saddle anaesthesia.\n   * Progressive neurological deficit (e.g., worsening weakness, loss of reflexes).\n2. Recent spinal surgery or invasive spinal procedures within the past 3 months.\n3. Severe cardiovascular or respiratory disease that prevents safe participation in mild to moderate exercise (e.g., unstable angina, uncontrolled heart failure).\n4. Pregnant women or those less than three months postpartum.\n5. Known allergy to materials used in the belt (e.g., Lycra or related fabrics).\n6. Cognitive impairment that prevents informed consent or ability to follow exercise instructions.\n7. Concurrent participation in another intervention trial that may interfere with the study outcomes.","ALL","18 Years",{"count":69,"type":70},40,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to evaluate whether a wearable biofeedback smartbelt system can improve pain and disability in adults with chronic lower back pain. The intervention combines a wearable belt that measures muscle activity with a mobile application that provides real-time feedback during exercise.\n\nThe main questions it aims to answer are:\n\n* Does the MMG-biofeedback system improve disability, as measured by the Oswestry Disability Index (ODI), compared to standard care alone over an 8-week period?\n* Does the system reduce perceived pain levels and improve exercise adherence in individuals with lower back pain over an 8-week period?\n\nResearchers will compare participants receiving the MMG-biofeedback belt alongside standard care to those receiving standard care alone to determine whether the addition of real-time muscle activation feedback leads to improved outcomes.\n\nParticipants will:\n\n* Be randomly assigned to either the intervention group (biofeedback system + standard care) or control group (standard care only)\n* Complete an 8-week home-based exercise programme, all participants are asked to complete the programme at least 5 times a week\n* Use the wearable belt and mobile application during exercise sessions (intervention group only)\n* Receive a booklet with the exercise programme and video links (control group only)\n* Complete questionnaires on pain, disability, and usability at baseline and after 8 weeks, and at a 3-month follow-up\n* Have their exercise adherence and engagement monitored throughout the study\n\nThe study includes an initial pilot phase to assess feasibility, followed by a larger randomised controlled phase to evaluate early clinical effectiveness.",[76,77],"Non-specific Low Back Pain","Low Back Pain",[79,80,81,82],"wearables","core muscle","exercise therapy","biofeedback","2026-04-21",{"date":85,"type":86},"2026-04-29","ACTUAL",{"date":88,"type":86},"2026-04-20",{"date":90,"type":70},"2027-04-20",{"name":5,"class":6},1]