[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658866":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":56,"studyPopulation":44,"armGroups":57,"interventions":70,"overallOfficials":44,"centralContacts":80,"locations":90,"responsibleParty":123,"collaborators":44,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":129,"sex":135,"minAge":136,"maxAge":44,"enrollmentInfo":137,"targetDuration":44,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":147,"overallStatus":157,"whyStopped":44,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":44},[9],{"measure":10,"description":11,"timeFrame":12},"Physical performance - Short Physical Performance Battery (SPPB)","The Short Physical Performance Battery (SPPB) is a standardized, validated measure of lower-extremity physical function in older adults. It combines three timed tests: standing balance (feet together, semi-tandem, and tandem positions), gait speed over a 4-meter walk, and lower-limb strength (five repeated chair stands, performed without using the arms). Each component is scored from 0 to 4, for a total score ranging from 0 (worst) to 12 (best). Lower scores indicate greater functional impairment and a higher risk of disability and falls.","Baseline (T0, day weight-bearing is authorized after surgery), at hospital discharge (T1, up to 30 days after baseline), and 1 month after discharge (T2)",[14,17,20,23,26,29,32,36,40],{"measure":15,"description":16,"timeFrame":12},"Pain - Visual Analog Scale (VAS)","The Visual Analog Scale (VAS) is a self-reported instrument for measuring subjective pain intensity using a 10-centimeter line, where 0 represents no pain and 10 represents the worst pain imaginable. The participant marks the point on the line that best reflects their pain; the resulting score, measured in centimeters, classifies pain as mild (1-3), moderate (4-7), or severe (8-10).",{"measure":18,"description":19,"timeFrame":12},"Muscle strength - Medical Research Council (MRC) Scale","The Medical Research Council (MRC) Scale is a manual muscle-testing method used to assess the strength of the knee flexor\u002Fextensor, hip flexor\u002Fextensor, and hip abductor muscle groups. Each muscle group is scored from 0 to 5, where 0 indicates no visible or palpable contraction and 5 indicates normal strength against maximal resistance.",{"measure":21,"description":22,"timeFrame":12},"Joint range of motion - Goniometry","Active joint range of motion is measured with a goniometer for knee flexion-extension and hip flexion-extension and abduction.",{"measure":24,"description":25,"timeFrame":12},"Basic activities of daily living - Barthel Index","The Barthel Index assesses a person's level of independence in ten basic activities of daily living, such as eating, bathing, dressing, and toileting. Scores from each activity are summed for a total ranging from 0 to 100, with higher scores indicating greater independence (100 = total independence; 0-20 = total dependence).",{"measure":27,"description":28,"timeFrame":12},"Ambulation capacity - Functional Ambulation Categories (FAC)","The Functional Ambulation Categories (FAC) is a 6-level scale that assesses a patient's walking ability, ranging from total inability to walk (level 0) to independent ambulation on any surface (level 5), based on the amount of physical or device-based support required.",{"measure":30,"description":31,"timeFrame":12},"Quality of life - SF-36 Health Survey","The 36-item Short Form Health Survey (SF-36) assesses health-related quality of life across eight domains: physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. Each domain is scored from 0 to 100, with higher scores indicating better health status.",{"measure":33,"description":34,"timeFrame":35},"Treatment adherence - structured REDCap logs","Adherence to the prescribed exercise program is recorded for both study arms using identical structured REDCap forms. It is broken down into three components: session adherence (percentage of additional sessions completed relative to those prescribed during the hospital stay), intra-session adherence (percentage of prescribed exercises completed per session, averaged across sessions), and weekly persistence (number of days per week with a completed session relative to the planned schedule).","Recorded daily (Monday through Friday) from baseline (T0) to hospital discharge (T1), up to 30 days",{"measure":37,"description":38,"timeFrame":39},"Usability - System Usability Scale (SUS) and adapted survey","Usability of the automated motivational support and movement-capture system is assessed in the experimental group using the System Usability Scale (SUS), a standardized 10-item questionnaire scored from 0 to 100, with higher scores indicating better perceived usability. It is complemented by a specific survey adapted for older adults, covering clarity, ease of use, sense of safety, and perception of the motivational feedback.","At the end of the intervention period, at hospital discharge (T1), up to 30 days after baseline (experimental group only)",{"measure":41,"description":42,"timeFrame":43},"Operational safety of the automated system","Operational safety of the automated motivational support and movement-capture system is assessed by recording any incidents or adverse events occurring during sessions, including the level of clinical supervision required.","Recorded during each session with the system, from baseline (T0) to hospital discharge (T1), up to 30 days (experimental group only)",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":48,"primaryPurpose":49,"observationalModel":44,"timePerspective":44,"maskingInfo":50},"RANDOMIZED","PARALLEL","Participants are randomized 1:1 to one of two parallel arms that run concurrently, with no crossover. Both arms receive standard hospital physiotherapy once daily, Monday through Friday, during the hospital stay. In addition, the experimental arm completes one daily session with an automated motivational support and movement-capture system, while the control arm completes an equivalent autonomous exercise session under the unit's current standard protocol, without the system. All participants are assessed at the same three time points - baseline, hospital discharge, and 1-month follow-up.","TREATMENT",{"masking":51,"maskingDescription":52,"whoMasked":53},"DOUBLE","The outcome assessor and the statistician responsible for the analysis are unaware of each participant's group assignment (double-blind). The participant and the physiotherapist administering the session cannot be masked, since the intervention - the session with the automated motivational support and movement-capture system using an RGB camera - is directly observable and non-pharmacological, making it infeasible to conceal from either the recipient or the person delivering it.",[54,55],"INVESTIGATOR","OUTCOMES_ASSESSOR","This randomized, parallel-group, controlled clinical trial is conducted in the Orthogeriatrics Unit of Ramón y Cajal University Hospital (Madrid, Spain) and follows the SPIRIT 2025 and CONSORT 2025 guidelines. It evaluates whether adding an automated motivational support and movement-capture system to standard hospital physiotherapy improves short- and medium-term functional recovery in frail older adults after hip fracture surgery, compared with standard physiotherapy alone.\n\nEligible participants are randomly assigned 1:1 to the experimental or control arm using concealed allocation (sequentially prepared, opaque envelopes drawn by the principal investigator). Outcome assessors and the statistician are blinded to group assignment.\n\nBoth arms receive one daily session of standard physiotherapy (Monday through Friday) during the hospital stay, following a structured two-phase program (seated exercises, then sit-to-stand and gait training). Participants in the experimental arm additionally complete one daily session with an automated motivational support and movement-capture system. The system uses a standard RGB camera and a body-pose estimation model (MediaPipe, inference mode) to record movement during the prescribed exercises. It performs no facial recognition or automated biometric identification and makes no clinical decisions. During the session it provides only pre-scheduled, generic auditory and visual motivational feedback (for example, session start\u002Fend cues and encouragement phrases), independent of how the patient performs the exercise; it gives no real-time technical correction. Video and derived movement data are analyzed afterward, off-line, for research purposes (for example, joint-angle estimation), and this analysis does not influence the feedback the patient receives. A study team member observes each session without intervening, except to stop it immediately in case of an adverse event, alarm, or other safety concern. Control-arm participants complete the same structured exercise program autonomously, per the unit's current protocol, without the motivational\u002Fcapture system.\n\nThe intervention under study is a support and data-capture tool, not an investigational medicinal product or medical device: it provides no diagnostic or therapeutic function and does not adapt its output to exercise quality. The trial is therefore not subject to Regulation (EU) 2017\u002F745, Royal Decree 1090\u002F2015, or AEMPS authorization requirements.\n\nOutcomes are assessed at three time points: baseline, once weight-bearing is authorized (T0); hospital discharge (T1); and 1-month follow-up (T2). The primary statistical analysis follows the intention-to-treat principle, with multiple imputation for missing data. Between-group adherence is compared using a symmetric, REDCap-based metric collected identically in both arms (structured observation by the study team in the experimental arm; a brief structured interview conducted by the treating physiotherapist in the control arm, given the autonomous nature of that arm's additional session).",[58,65],{"label":59,"type":60,"description":61,"interventionNames":62},"Experimental Group - AI-Assisted Motivational Physiotherapy","EXPERIMENTAL","Participants receive standard hospital physiotherapy plus one daily session with the automated motivational support and movement-capture system (RGB camera, generic motivational feedback), Monday through Friday during the hospital stay.",[63,64],"Other: Conventional hospital physiotherapy","Device: Automated motivational support and movement-capture system",{"label":66,"type":67,"description":68,"interventionNames":69},"Control Group - Conventional Physiotherapy","ACTIVE_COMPARATOR","Participants receive standard hospital physiotherapy plus an equivalent autonomous exercise session per the unit's current protocol, Monday through Friday during the hospital stay, without the motivational support\u002Fmovement-capture system.",[63],[71,75],{"type":6,"name":72,"description":73,"armGroupLabels":74,"otherNames":44},"Conventional hospital physiotherapy","Standard structured physiotherapy program delivered once daily, Monday through Friday, during the hospital stay, following a two-phase protocol (seated exercises; sit-to-stand and gait training).",[66,59],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":44},"DEVICE","Automated motivational support and movement-capture system","RGB camera-based system using a body-pose estimation model (MediaPipe) to record movement during exercise sessions for deferred, off-line biomechanical analysis. Provides only pre-scheduled, generic auditory and visual motivational feedback, independent of how the patient performs the exercise; performs no facial recognition, no automated biometric identification, and no real-time technical correction.",[59],[81,86],{"name":82,"role":83,"phone":84,"phoneExt":44,"email":85},"Verónica O Ocaña, Fisioterapia","CONTACT","+34 676799928","veronica.ocana@salud.madrid.org",{"name":87,"role":83,"phone":88,"phoneExt":44,"email":89},"Manuel Vicente M Mejía, Médico Geriatra","+34 679155699","mvmra73@gmail.com",[91],{"facility":92,"status":44,"city":93,"state":93,"zip":94,"country":95,"countryCode":96,"cosmosGeoPoint":97,"geoPoint":102,"contacts":103},"Hospital Universitario Ramón y Cajal","Madrid","28034","Spain","ES",{"type":98,"coordinates":99},"Point",[100,101],-3.70256,40.4165,{"lat":101,"lon":100},[104,107,110,113,115,117,119,121],{"name":105,"role":83,"phone":84,"phoneExt":44,"email":106},"Verónica O Ocaña García, Fisioterapia","mailto:veronica.ocana@salud.madrid.org",{"name":108,"role":83,"phone":88,"phoneExt":44,"email":109},"Manuel Vicente M Mejía Ramírez de Arellano, Médico Geriatra","mrmra73@gmail.com",{"name":111,"role":112,"phone":44,"phoneExt":44,"email":44},"Mónica B Barbero Campos, Fisioterapia","SUB_INVESTIGATOR",{"name":114,"role":112,"phone":44,"phoneExt":44,"email":44},"Teresa Emilia F Fernández Pardo, Fisioterapia",{"name":116,"role":112,"phone":44,"phoneExt":44,"email":44},"Alicia S Seco Martínez, Fisioterapia",{"name":118,"role":112,"phone":44,"phoneExt":44,"email":44},"Ana Isabel R Rodríguez Sánchez, Fisioterapia",{"name":120,"role":112,"phone":44,"phoneExt":44,"email":44},"Esperanza Macarena D Díaz Soto, Fisioterapia",{"name":122,"role":112,"phone":44,"phoneExt":44,"email":44},"María T Tamargo Piedra, Médica Rehabilitadora",{"type":124,"investigatorFullName":125,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Veronica Ocaña","Principal Investigator","100658866","ai-supported-physiotherapy-after-hip-fracture-in-frail-older-adults-100658866",false,"NCT07857707","AI-Supported Physiotherapy After Hip Fracture in Frail Older Adults","Hospital-Based Physiotherapy With Automated Motivational Support and Motion Capture in Frail Patients With Hip Fracture: A Randomized Clinical Trial","Fisio-ACTIVA","Inclusion Criteria:\n\n* Age ≥ 70 years\n* Diagnosis of hip fracture due to bone fragility\n* Hospital admission to the Orthogeriatrics Unit, Ramón y Cajal University Hospital (Ward 3DA, rooms 301-314)\n* Signed informed consent\n* Frailty, assessed with the FRAIL-Spain scale (score 3 to 5)\n* Weight-bearing authorized by the medical team (Trauma Surgery Department)\n\nExclusion Criteria:\n\n* Hip fracture due to high-energy trauma\n* Pathological fracture (bone metastasis or tumor)\n* Pre-fracture ambulation capacity (FAC) of 0 to 2\n* Other coexisting fractures\n* Inability to complete clinical follow-up\n* Lack of cooperation with the physiotherapy program\n* Neurodegenerative disease at a moderate stage or beyond (cognitive impairment GDS ≥ 6, or Parkinson's disease Hoehn-Yahr stage 3-5)\n* Institutionalized patients (due to earlier hospital discharge)\n* Post-surgical complications (e.g., infection, poor surgical wound healing, suspected deep vein thrombosis)\n* History of underlying conditions affecting balance or posture (cancer, dizziness, vertigo, or stroke)\n* Physical disability that could compromise sample homogeneity\n* Sensory impairment preventing use of digital tools\n* Severe cognitive impairment (Lobo's Mini-Mental State Examination score ≤ 9, equivalent to GDS ≥ 6)","ALL","70 Years",{"count":138,"type":139},48,"ESTIMATED","INTERVENTIONAL",[142],"NA","Purpose Hip fractures in older adults often cause a serious loss of strength and independence. Physical therapy helps people recover, but patients do not always exercise consistently or correctly. This study tests whether adding an automated motivational support tool to physical therapy helps patients recover better than physical therapy alone.\n\nHow the tool works The tool uses a regular camera to record movement during exercise. It does not use facial recognition. It gives the patient simple, encouraging messages, such as \"great job\" or \"keep going.\" It does not give medical advice or correct the patient's movements during the session. The research team reviews the recordings later; they are not reviewed in real time.\n\nWho can join People age 70 or older who had surgery for a hip fracture and are staying in the Orthogeriatrics Unit at Ramón y Cajal University Hospital, in Madrid, Spain.\n\nWhat happens in the study Forty-eight people will take part.\n\nHalf will receive standard physical therapy plus one daily session with the motivational tool.\n\nHalf will receive standard physical therapy alone.\n\nResearchers will measure physical performance with a short walking and balance test. They will measure it three times: at the start, when the patient leaves the hospital, and one month later.\n\nWhy it matters This study will show whether an automated motivational tool helps patients recover more strength and function after a hip fracture.",[145,146],"Hip Fractures","Frailty",[148,149,150,151,152,153,154,155,156],"Physiotherapy","Hip fracture","Frail elderly","Rehabilitation","Therapeutic adherence","Artificial intelligence","Motion capture","Motivational feedback","Digital health","NOT_YET_RECRUITING","2026-09-29",{"date":160,"type":161},"2026-10-05","ACTUAL",{"date":163,"type":139},"2026-10",{"date":165,"type":139},"2027-12-31",{"name":5,"class":6},1]