Hip FracturesFisio-ACTIVANCT07857707
AI-Supported Physiotherapy After Hip Fracture in Frail Older Adults
A study testing Conventional hospital physiotherapy and Automated motivational support and movement-capture system in people with Hip Fractures and Frailty, run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Hip Fractures, Frailty
- What is being tested?
- Conventional hospital physiotherapy and Automated motivational support and movement-capture system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 70 years
- Diagnosis of hip fracture due to bone fragility
- Hospital admission to the Orthogeriatrics Unit, Ramón y Cajal University Hospital (Ward 3DA, rooms 301-314)
- Signed informed consent
- Frailty, assessed with the FRAIL-Spain scale (score 3 to 5)
- Weight-bearing authorized by the medical team (Trauma Surgery Department)
Who cannot join
- Hip fracture due to high-energy trauma
- Pathological fracture (bone metastasis or tumor)
- Pre-fracture ambulation capacity (FAC) of 0 to 2
- Other coexisting fractures
- Inability to complete clinical follow-up
- Lack of cooperation with the physiotherapy program
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- Neurodegenerative disease at a moderate stage or beyond (cognitive impairment GDS ≥ 6, or Parkinson's disease Hoehn-Yahr stage 3-5)
- Institutionalized patients (due to earlier hospital discharge)
- Post-surgical complications (e.g., infection, poor surgical wound healing, suspected deep vein thrombosis)
- History of underlying conditions affecting balance or posture (cancer, dizziness, vertigo, or stroke)
- Physical disability that could compromise sample homogeneity
- Sensory impairment preventing use of digital tools
- Severe cognitive impairment (Lobo's Mini-Mental State Examination score ≤ 9, equivalent to GDS ≥ 6)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario Ramón y Cajal
Madrid, Madrid, 28034
Verónica O Ocaña García, Fisioterapia, +34 676799928, mailto:veronica.ocana@salud.madrid.org
Manuel Vicente M Mejía Ramírez de Arellano, Médico Geriatra, +34 679155699, mrmra73@gmail.com
About this study
Official title: Hospital-Based Physiotherapy With Automated Motivational Support and Motion Capture in Frail Patients With Hip Fracture: A Randomized Clinical Trial
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.
How 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.
Read more
Who 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.
What happens in the study Forty-eight people will take part.
Half will receive standard physical therapy plus one daily session with the motivational tool.
Half will receive standard physical therapy alone.
Researchers 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.
Why it matters This study will show whether an automated motivational tool helps patients recover more strength and function after a hip fracture.
Read the detailed description
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.
Eligible 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.
Both 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/end 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/capture system.
The 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) 2017/745, Royal Decree 1090/2015, or AEMPS authorization requirements.
Outcomes 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).
- Conditions
- Hip Fractures, Frailty
- Being tested
- Conventional hospital physiotherapy, Automated motivational support and movement-capture system
- Keywords
- Physiotherapy, Hip fracture, Frail elderly, Rehabilitation, Therapeutic adherence, Artificial intelligence, Motion capture, Motivational feedback, Digital health
- Medical subject headings
- Hip Fractures, Frailty, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional hospital physiotherapyOther
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).
Automated motivational support and movement-capture systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Conventional hospital physiotherapy; Device: Automated motivational support and movement-capture system |
| 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/movement-capture system. Receives: Other: Conventional hospital physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Secondary outcomes (9)
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).
Measured: 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)
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/extensor, hip flexor/extensor, 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.
Measured: 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)
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.
Measured: 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)
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).
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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).
Measured: Recorded daily (Monday through Friday) from baseline (T0) to hospital discharge (T1), up to 30 days
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.
Measured: At the end of the intervention period, at hospital discharge (T1), up to 30 days after baseline (experimental group only)
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.
Measured: Recorded during each session with the system, from baseline (T0) to hospital discharge (T1), up to 30 days (experimental group only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study startOct 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Veronica Ocaña, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857707
- Sponsor's protocol ID
- B07
- Other IDs
- 016/26, B07
- Acronym
- Fisio-ACTIVA
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team, because the dataset includes special-category personal data - video and audio recordings and health-related information - protected under the EU General Data Protection Regulation (GDPR) and Spanish Law 3/2018 (LOPDGDD). Participants provided informed consent for defined research purposes only (primary analysis and, where separately authorized, AI model development), not for public data sharing or secondary use by third parties. Given the small sample size (n=48) and the identifiable nature of video-based movement data, de-identification to a degree sufficient for public sharing cannot be guaranteed. Data are pseudonymized, access is restricted to authorized investigators under a Data Processing Agreement (GDPR Article 28) between Hospital Universitario Ramón y Cajal and Universidad Rey Juan Carlos, and are retained for a maximum of 5 years after study completion.
Publications
Sevilla-Gonzalez MDR, Moreno Loaeza L, Lazaro-Carrera LS, Bourguet Ramirez B, Vazquez Rodriguez A, Peralta-Pedrero ML, Almeda-Valdes P. Spanish Version of the System Usability Scale for the Assessment of Electronic Tools: Development and Validation. JMIR Hum Factors. 2020 Dec 16;7(4):e21161. doi: 10.2196/21161.
PubMed 33325828Oh YJ, Zhang J, Fang ML, Fukuoka Y. A systematic review of artificial intelligence chatbots for promoting physical activity, healthy diet, and weight loss. Int J Behav Nutr Phys Act. 2021 Dec 11;18(1):160. doi: 10.1186/s12966-021-01224-6.
PubMed 34895247Kwon S, Perera S, Pahor M, Katula JA, King AC, Groessl EJ, Studenski SA. What is a meaningful change in physical performance? Findings from a clinical trial in older adults (the LIFE-P study). J Nutr Health Aging. 2009 Jun;13(6):538-44. doi: 10.1007/s12603-009-0104-z.
PubMed 19536422Nuevo M, Rodriguez-Rodriguez D, Jauregui R, Fabrellas N, Zabalegui A, Conti M, Prat-Fabregat S. Telerehabilitation following fast-track total knee arthroplasty is effective and safe: a randomized controlled trial with the ReHub(R) platform. Disabil Rehabil. 2024 Jun;46(12):2629-2639. doi: 10.1080/09638288.2023.2228689. Epub 2023 Jul 5.
PubMed 37403684Hopewell S, Chan AW, Collins GS, Hrobjartsson A, Moher D, Schulz KF, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne D, Farmer A, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson D, Vohra S, White IR, Boutron I. CONSORT 2025 statement: updated guideline for reporting randomised trials. BMJ. 2025 Apr 14;389:e081123. doi: 10.1136/bmj-2024-081123.
PubMed 40228833Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: Updated guideline for protocols of randomised trials. PLoS Med. 2025 Apr 28;22(4):e1004589. doi: 10.1371/journal.pmed.1004589. eCollection 2025 Apr.
PubMed 40294521Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.
PubMed 16696738Kim S, Kim S, Kim H, Kim H, Yoo JI. Cross-sectional study comparing smart insoles and manual methods for short physical performance battery in hip fracture patients. Aging Clin Exp Res. 2025 Mar 1;37(1):61. doi: 10.1007/s40520-025-02960-6.
PubMed 40021544