[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649736":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":37,"centralContacts":41,"locations":51,"responsibleParty":69,"collaborators":12,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":12,"eligibilityCriteria":78,"healthyVolunteers":79,"sex":80,"minAge":81,"maxAge":12,"enrollmentInfo":82,"targetDuration":12,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":98,"whyStopped":12,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Sharjah","OTHER",[8,13,16,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1: Observational \u002F High Fall-Risk Older Adults - Multimodal Assessment","NO_INTERVENTION","Participants aged ≥65 years classified as high fall risk (based on fall history and\u002For impaired functional performance) will undergo a comprehensive multimodal assessment to characterize neural, neurocognitive, and biomechanical determinants of fall risk. No therapeutic intervention will be administered.\n\nAssessments include:\n\nNeurophysiological recordings using electroencephalography and electromyography during standardized balance tasks Neurocognitive assessment using functional near-infrared spectroscopy during single- and dual-task conditions Quantitative gait and balance assessment using wearable smartphone-based sensors Functional clinical measures of mobility and balance\n\nThe purpose of this arm is to identify mechanistic differences and support neurophysiological phenotyping.",null,{"label":14,"type":10,"description":15,"interventionNames":12},"Phase 1: Observational \u002F Low\u002FNo Fall-Risk Older Adults - Multimodal Assessment","Participants aged ≥65 years classified as low or no fall risk will undergo the same multimodal assessment protocol as the high-risk group. This arm serves as a reference group to establish normative ranges for neural, neurocognitive, and biomechanical variables\n\nAssessments include:\n\n* Neurophysiological recordings using electroencephalography and electromyography during standardized balance tasks\n* Neurocognitive assessment using functional near-infrared spectroscopy during single- and dual-task conditions\n* Quantitative gait and balance assessment using wearable smartphone-based sensors\n* Functional clinical measures of mobility and balance\n\nData from this group will be used to define reference thresholds for neurophysiological classification and comparative analysis.",{"label":17,"type":18,"description":19,"interventionNames":20},"Phase 2: Randomized Controlled Trial (Intervention) \u002F Personalized Neurophysiological Rehabilitation","EXPERIMENTAL","Participants classified as high fall risk will receive a personalized rehabilitation program tailored to their individual neurophysiological and neurocognitive profile, derived from Phase 1 assessments.\n\nThe intervention targets underlying neural control mechanisms and is adapted based on identified control strategies (e.g., cortical-dominant, reflex-dominant, or integrated control).\n\nIntervention components may include:\n\nTask-specific balance and gait training under variable sensory conditions Dual-task training to improve cognitive-motor integration External focus and rhythm-based training to enhance movement automaticity Reaction-based and perturbation training to improve adaptability Progressive modulation of task complexity based on participant response\n\nProgram details:\n\nDuration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes\n\nThe intervention is dynamically progressed based on neurophysiological and functional responses.",[21],"Other: Personalized Neurophysiological Rehabilitation",{"label":23,"type":24,"description":25,"interventionNames":26},"Phase 2: Randomized Controlled Trial (Intervention)\u002FConventional Fall-Prevention Exercise Program","ACTIVE_COMPARATOR","Participants classified as high fall risk will receive a standard evidence-based fall-prevention exercise program consistent with current clinical guidelines.\n\nThe intervention focuses on general physical improvements rather than individualized neural mechanisms.\n\nIntervention components include:\n\nBalance training (static and dynamic postural control exercises) Lower-limb strengthening exercises (e.g., sit-to-stand, step-ups, resistance training) Gait and functional mobility training (walking, turning, obstacle negotiation) Flexibility and mobility exercises Education on fall prevention strategies\n\nProgram details:\n\nDuration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes\n\nProgression is based on standard clinical criteria such as safety, tolerance, and performance.",[27],"Other: Conventional Fall-Prevention Exercise Program",[29,33],{"type":6,"name":30,"description":31,"armGroupLabels":32,"otherNames":12},"Personalized Neurophysiological Rehabilitation","The intervention targets underlying neural control mechanisms and is adapted based on identified control strategies (e.g., cortical-dominant, reflex-dominant, or integrated control).\n\nIntervention components may include:\n\nTask-specific balance and gait training under variable sensory conditions Dual-task training to improve cognitive-motor integration External focus and rhythm-based training to enhance movement automaticity Reaction-based and perturbation training to improve adaptability Progressive modulation of task complexity based on participant response\n\nProgram details:\n\nDuration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes\n\nThe intervention is dynamically progressed based on neurophysiological and functional responses.",[17],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":12},"Conventional Fall-Prevention Exercise Program","The intervention focuses on general physical improvements rather than individualized neural mechanisms.\n\nIntervention components include:\n\nBalance training (static and dynamic postural control exercises) Lower-limb strengthening exercises (e.g., sit-to-stand, step-ups, resistance training) Gait and functional mobility training (walking, turning, obstacle negotiation) Flexibility and mobility exercises Education on fall prevention strategies\n\nProgram details:\n\nDuration: 8-12 weeks Frequency: 2-3 supervised sessions per week Session length: 45-60 minutes\n\nProgression is based on",[23],[38],{"name":39,"affiliation":5,"role":40},"Ibrahim Moustafa Abuamer, professor","STUDY_DIRECTOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":12,"email":46},"Aisha Salim Alsuwaidi, PhD","CONTACT","+971507373053","U25100059@sharjah.ac.ae",{"name":48,"role":44,"phone":49,"phoneExt":12,"email":50},"Ibrahim Mostafa Abuamr, Professor","+972565057513","iabuamr@sharjah.ac.ae",[52],{"facility":5,"status":12,"city":53,"state":12,"zip":12,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Sharjah city","United Arab Emirates","AE",{"type":57,"coordinates":58},"Point",[59,60],55.41221,25.3342,{"lat":60,"lon":59},[63,66],{"name":64,"role":44,"phone":65,"phoneExt":12,"email":50},"Ibrahim M Abuamr, professor","+97165055713",{"name":67,"role":68,"phone":12,"phoneExt":12,"email":12},"Aisha S Alsuwaidi, PhD","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Aisha Salim Alsuwaidi","principial investigator - Physiotherapy Department","100649736","neural-cognitive-and-biomechanical-determinants-of-falls-in-older-adults-100649736",false,"NCT07739056","Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults","Neural, Cognitive, and Biomechanical Determinants of Falls in Older Adults: A Two-Phase Multimodal Investigation With a Phenotype-Guided Rehabilitation Trial","Inclusion Criteria:\n\n* Participants must meet all of the following criteria:\n\n  * Age ≥ 65 years\n  * Community-dwelling\n  * Ability to ambulate independently (with or without assistive device)\n  * Ability to understand instructions and provide informed consent\n\nParticipants will be stratified into fall-risk categories based on established criteria:\n\n* High fall risk: history of ≥1 fall in the previous 12 months and\u002For impaired functional performance (e.g., TUG \\> 13.5 s or BBS ≤49)\n* Low\u002Fno fall risk: no falls and preserved functional mobility These criteria are consistent with previously published fall-prevention trials.\n\nExclusion Criteria:\n\n* Participants will be excluded if they have:\n\n  * Neurological conditions affecting gait or balance (e.g., stroke, Parkinson's disease)\n  * Severe musculoskeletal disorders limiting mobility\n  * Severe cognitive impairment (e.g., inability to follow instructions or MoCA \\\u003C 18)\n  * Uncontrolled cardiovascular or metabolic conditions\n  * Current participation in structured rehabilitation programs\n  * Contraindications to EEG, EMG, or fNIRS measurements",true,"ALL","65 Years",{"count":83,"type":84},80,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial with an embedded observational phase is to evaluate whether a phenotype-guided, personalized rehabilitation program can improve fall risk and underlying neural control mechanisms in older adults aged ≥65 years, including both high and low fall-risk individuals.\n\nThe main questions it aims to answer are:\n\nDo older adults at high fall risk exhibit altered neural, neurocognitive, and biomechanical profiles compared with low\u002Fno fall-risk individuals? Does personalized rehabilitation guided by neurophysiological and neurocognitive profiles result in greater reductions in fall risk and improvements in motor control compared with conventional rehabilitation?\n\nResearchers will compare personalized phenotype-guided rehabilitation to conventional evidence-based fall-prevention exercise to determine whether targeted, mechanism-based intervention leads to superior clinical and mechanistic outcomes.\n\nParticipants will:\n\nUndergo a comprehensive multimodal assessment including neurophysiological (EEG, EMG), neurocognitive (fNIRS, dual-task testing), and biomechanical (gait and balance) measures Be classified into fall-risk and neurophysiological control profiles based on assessment results (Phase 2 - high fall-risk participants only) be randomly assigned to either personalized rehabilitation or conventional rehabilitation Attend supervised exercise sessions 2-3 times per week for 8-12 weeks Complete gait, balance, and cognitive-motor assessments before and after the intervention Record falls prospectively using monthly fall diaries and follow-up monitoring over 3-6 months",[90],"Accidental Falls\u002FPrevention & Control",[92,93,94,95,96,97],"Fall risk","Older adults","Balance","Neural control","Cognitive-motor integration","Phenotype-guided therapy","NOT_YET_RECRUITING","2026-07-27",{"date":101,"type":102},"2026-07-31","ACTUAL",{"date":104,"type":84},"2026-12-31",{"date":106,"type":84},"2028-12-31",{"name":5,"class":6},1]