AI-Supported Physiotherapy After Hip Fracture in Frail Older Adults

NCT07857707 | Not Yet Recruiting DMC

• 2 other identifiers: B07016/26
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Hip Fractures; Frailty

Keywords

Physiotherapy; Hip fracture; Frail elderly; Rehabilitation; Therapeutic adherence; Artificial intelligence; Motion capture; Motivational feedback; Digital health

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (9)

• Pain - Visual Analog Scale (VAS)

  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

  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

  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

  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)

  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)

Study Arms (2)

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.

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.

Other: Conventional hospital physiotherapy

Interventions

Conventional hospital physiotherapy OTHER

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).

Control Group - Conventional Physiotherapy; Experimental Group - AI-Assisted Motivational Physiotherapy

Automated motivational support and movement-capture system DEVICE

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.

Experimental Group - AI-Assisted Motivational Physiotherapy

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (8)

• 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.

  PMID: 33325828 BACKGROUND

• Oh 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.

  PMID: 34895247 BACKGROUND

• Kwon 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.

  PMID: 19536422 BACKGROUND

• Nuevo 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.

  PMID: 37403684 BACKGROUND

• Hopewell 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.

  PMID: 40228833 BACKGROUND

• Chan 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.

  PMID: 40294521 BACKGROUND

• Perera 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.

  PMID: 16696738 BACKGROUND

• Kim 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.

  PMID: 40021544 BACKGROUND

Related Links

• News article describing the use of an artificial intelligence system to support physiotherapy rehabilitation in older patients after hip fracture at Ramón y Cajal University Hospital.
• Health-sector news article reporting on the clinical trial's use of AI-assisted physiotherapy to improve recovery in frail patients after hip fracture surgery.
• News feature on the clinical trial evaluating AI-guided rehabilitation for older adults, launching in Madrid.
• Local news article covering the launch of the AI-assisted physiotherapy program for frail patients after hip fracture at Ramón y Cajal University Hospital.

MeSH Terms

Conditions

Hip Fractures; Frailty; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Health Behavior; Behavior

Central Study Contacts

Verónica O Ocaña, Fisioterapia

CONTACT

+34 676799928; veronica.ocana@salud.madrid.org

Manuel Vicente M Mejía, Médico Geriatra

CONTACT

+34 679155699; mvmra73@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 5, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 5, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)