[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589893":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":47,"studyPopulation":38,"armGroups":48,"interventions":61,"overallOfficials":70,"centralContacts":74,"locations":80,"responsibleParty":96,"collaborators":100,"id":103,"slug":38,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":38,"eligibilityCriteria":108,"healthyVolunteers":104,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":38,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":38,"overallStatus":123,"whyStopped":38,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":133},{"fullName":5,"class":6},"University of Karachi","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":38},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Pain Intensity (VAS Score)","Pain intensity will be measured using the Visual Analog Scale (VAS), a 10-cm horizontal line where participants mark their perceived pain level from 0 (no pain) to 10 (worst imaginable pain).","Baseline, Week 6, Week 12",{"measure":14,"description":15,"timeFrame":12},"Functional Mobility (Timed Up and Go Test)","Functional mobility will be assessed using the Timed Up and Go (TUG) Test. Participants will be timed as they rise from a chair, walk 3 meters, turn, return, and sit down again.",{"measure":17,"description":18,"timeFrame":12},"Range of Motion (Goniometry)","Joint range of motion will be measured using a goniometer to assess changes in movement capacity of affected joints (e.g., knees, shoulders).",[20,23,27,31,35],{"measure":21,"description":22,"timeFrame":12},"Heart Rate Variability (HRV)","HRV will be evaluated using time-domain (e.g., RMSSD) and frequency-domain (e.g., LF\u002FHF ratio) metrics recorded by wearable devices.",{"measure":24,"description":25,"timeFrame":26},"Patient Adherence","Adherence to prescribed exercises will be monitored through device usage logs, measuring frequency and duration of engagement with the intervention.","Throughout the 12-week intervention",{"measure":28,"description":29,"timeFrame":30},"Change in Depression Severity (Beck Depression Inventory Score)","The BDI score ranges from 0 to 63. Higher scores indicate more severe depressive symptoms.","Baseline, Week 12",{"measure":32,"description":33,"timeFrame":34},"System Usability and Patient Satisfaction","The SUS consists of 10 items, each rated on a 5-point Likert scale (from Strongly Agree to Strongly Disagree). The total score ranges from 0 to 100. A higher score indicates better usability and user satisfaction.","Week 12",{"measure":36,"description":37,"timeFrame":30},"Change in Quality of Life (SF-36 Health Survey Score)","The SF-36 consists of 8 scaled scores (0-100). Higher scores indicate better health status.",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","Participants will be randomized into two parallel groups:\n\nIntervention Group - receives wearable biofeedback devices with guided exercises and virtual physiotherapy.\n\nControl Group - receives standard physiotherapy exercises without biofeedback.","TREATMENT",{"masking":45,"maskingDescription":46,"whoMasked":38},"NONE","Due to the nature of the intervention (wearable devices and virtual consultations), blinding of participants and care providers is not feasible. This is an open-label study.","Arthritis and fibromyalgia are common chronic musculoskeletal conditions among the elderly population, contributing to significant pain, reduced mobility, and diminished quality of life. In urban centers like Karachi, Pakistan, access to consistent and effective physiotherapy is often hindered by mobility limitations and inadequate healthcare infrastructure. This randomized controlled trial (RCT) investigates the efficacy of wearable biofeedback devices as an innovative approach to address these challenges.\n\nA total of 120 elderly participants diagnosed with arthritis and\u002For fibromyalgia will be enrolled and randomized into two groups (60 participants per group). The intervention group will receive wearable biofeedback devices that monitor physiological parameters such as heart rate variability (HRV) and provide real-time feedback during guided home-based exercises, complemented by virtual physiotherapy consultations. The control group will follow standard physiotherapy exercise routines without biofeedback or virtual support.\n\nPrimary outcome measures include pain intensity (measured using a standardized pain scale), functional mobility (assessed via timed mobility tests), and joint range of motion. Secondary outcomes will assess heart rate variability, patient adherence to exercise protocols, and changes in psychological well-being.\n\nThis study seeks to determine whether wearable biofeedback can enhance rehabilitation outcomes, promote exercise adherence, and offer a viable, accessible alternative to conventional physiotherapy. If successful, the intervention could transform chronic pain management and rehabilitation strategies for aging populations, especially in resource-constrained urban environments.",[49,55],{"label":50,"type":51,"description":52,"interventionNames":53},"Intervention Group","EXPERIMENTAL","Participants in this group will receive wearable biofeedback devices integrated with guided exercise routines and virtual physiotherapy consultations over a set period (e.g., 12 weeks). The devices will provide real-time physiological monitoring and feedback, including heart rate variability (HRV), to guide home-based rehabilitation.\n\nIntervention Name:\n\nWearable Biofeedback + Virtual Physiotherapy\n\nIntervention Type:\n\nDevice (or Behavioral, depending on how the registry classifies it)\n\nIntervention Description:\n\nParticipants will use wearable devices designed to monitor physiological parameters and provide real-time feedback during exercises. The intervention includes remote guidance from physiotherapists via virtual consultations.",[54],"Other: Wearable Biofeedback + Virtual Physiotherapy",{"label":56,"type":57,"description":58,"interventionNames":59},"Control Group","ACTIVE_COMPARATOR","Participants in this group will perform a standard physiotherapy exercise regimen without any wearable biofeedback device or virtual consultation support.\n\nIntervention Name:\n\nStandard Physiotherapy Exercises\n\nIntervention Type:\n\nBehavioral\n\nIntervention Description:\n\nParticipants will be given printed or video instructions for standard physiotherapy exercises commonly used for arthritis and fibromyalgia management, without any digital monitoring or remote guidance.",[60],"Other: Standard Physiotherapy Exercises",[62,66],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":38},"Wearable Biofeedback + Virtual Physiotherapy","Participants will use wearable devices designed to monitor physiological parameters and provide real-time feedback during exercises. The intervention includes remote guidance from physiotherapists via virtual consultations.",[50],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":38},"Standard Physiotherapy Exercises","Participants will be given printed or video instructions for standard physiotherapy exercises commonly used for arthritis and fibromyalgia management, without any digital monitoring or remote guidance.",[56],[71],{"name":72,"affiliation":5,"role":73},"Basit Ansari, Ph.D.","STUDY_DIRECTOR",[75],{"name":76,"role":77,"phone":78,"phoneExt":38,"email":79},"Shamoon Noushad, Ph.D.","CONTACT","03333549258","shamoon@aeirc-edu.com",[81],{"facility":5,"status":38,"city":82,"state":83,"zip":84,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":92,"contacts":93},"Karachi","Sindh","78500","Pakistan","PK",{"type":88,"coordinates":89},"Point",[90,91],67.0104,24.8608,{"lat":91,"lon":90},[94],{"name":95,"role":77,"phone":38,"phoneExt":38,"email":38},"Muhammad Jabbar, M.Phil",{"type":97,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Shamoon Noushad","Professor",[101],{"name":102,"class":6},"Advanced Education & Research Center","100589893",false,"NCT06960330","Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation","Wearable Biofeedback Devices for Remote Physiotherapy and Rehabilitation for Elderly Patients Suffering From Arthritis and Fibromyalgia","Inclusion Criteria:\n\nElderly adults aged 60-80 years diagnosed with arthritis or fibromyalgia.\n\nExperiencing moderate to severe pain and mobility limitations.\n\nNo recent surgical interventions or contraindications for physiotherapy.\n\nAccess to smartphones and internet connectivity for remote monitoring.\n\nExclusion Criteria:\n\nPatients with severe cognitive impairments affecting adherence to rehabilitation.\n\nPresence of comorbidities that contraindicate physiotherapy (e.g., severe cardiac conditions).\n\nLack of access to digital devices required for remote monitoring.","ALL","60 Years","80 Years",{"count":113,"type":114},120,"ESTIMATED","INTERVENTIONAL",[117],"NA","This study evaluates the effectiveness of wearable biofeedback devices in improving pain, mobility, and rehabilitation outcomes in elderly patients with arthritis and fibromyalgia in Karachi, Pakistan. In a randomized controlled trial involving 120 participants, one group will use biofeedback-integrated devices with guided exercises and virtual consultations, while the control group receives standard physiotherapy. The results will inform the potential of digital health solutions to improve accessibility and outcomes in remote rehabilitation for chronic pain management.",[120,121,122],"Arthritis","Fibromyalgia","Chronic Pain","NOT_YET_RECRUITING","2025-04-28",{"date":126,"type":127},"2025-05-07","ACTUAL",{"date":129,"type":114},"2025-05-06",{"date":131,"type":114},"2028-02-01",{"name":5,"class":6},1]