Digital rehabilitation to improve cognition and mobility after hip fracture in older adults
Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms
NA · C.O.T. Cure Ortopediche Traumatologiche S.p.A. · NCT07392515
This program will test whether adding sensor-based digital exercises to usual rehab helps people aged 65–89 regain thinking skills and walking ability after hip fracture surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 65 Years to 89 Years |
| Sex | All |
| Sponsor | C.O.T. Cure Ortopediche Traumatologiche S.p.A. (other) |
| Locations | 2 sites (Messina, Italy and 1 other locations) |
| Trial ID | NCT07392515 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized inpatient study enrolls clinically stable patients aged 65–89 after surgical repair of proximal femoral fracture and randomizes them to usual rehabilitation or to an integrated program combining conventional therapy with sensor-based digital training. The program delivers 18 sessions over about 3–4 weeks (5–6 sessions per week), with the experimental group performing roughly one-third of sessions using sensor devices that provide real-time visual and auditory feedback plus two-thirds conventional therapy. Outcomes include changes in cognitive function, motor function, and overall abilities, and the study also collects feasibility and healthcare-professional perspective data to examine routine implementation. Randomization is centralized and stratified by center and age group in this non-profit post-market evaluation conducted at two Italian rehabilitation centers.
Who should consider this trial
Good fit: Ideal candidates are clinically stable patients aged 65–89 admitted for inpatient rehabilitation within 15 days after surgical treatment of a proximal femur fracture (total or partial hip arthroplasty, or intramedullary nailing).
Not a fit: Patients with severe cognitive or behavioral disorders, mechanical instability of the implant, clinical instability, major neurological or chronic disabilities limiting ambulation, or additional fractures that prevent rehabilitation are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, adding sensor-based digital training could speed recovery of mobility and cognitive function and make rehabilitation more engaging and consistent.
How similar studies have performed: Smaller trials and pilot studies of sensor-based or digital rehabilitation in older adults and post-orthopedic rehab have shown promising motor and cognitive improvements, but large multicenter randomized evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 65 and 89 years * Patients who have undergone one of the following surgical treatments specifically for proximal femur fracture including Total hip arthroplasty (total hip replacement), Partial hip arthroplasty (hemiarthroplasty), Intramedullary nailing * Time since surgery not exceeding 15 days * Clinical stability * Patients admitted to the rehabilitation wards of the centers involved in the study and therefore eligible for rehabilitative therapy. Exclusion Criteria: * Age \> 90 years * Age \< 65 years * Refusal to sign the informed consent form * Behavioral or cognitive disorders limiting compliance with the rehabilitative treatment * Presence of mechanical instability of the implanted surgical device * Clinical instability (e.g., sepsis, severe anemia, cardiorespiratory failure) or pre-existing comorbidities affecting ambulation (neurological diseases or chronic pre-existing disabilities) * Concomitant presence of other fractures that prevent the possibility of carrying out a rehabilitative treatment * Severe visual impairments not correctable with lenses that prevent the patient from performing the treatment using digital tools * Pre-existing motor disability prior to the femur fracture due to other systemic diseases (e.g., advanced-stage neurodegenerative diseases, severe heart failure) * Conditions contraindicating the use of sensors (pacemaker, epilepsy, skin lesions, open wounds, and severe allergies in areas of contact with the devices).
Where this trial is running
Messina, Italy and 1 other locations
- COT - Cure Ortopediche Traumatologiche — Messina, Italy, Italy (RECRUITING)
- Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza — Roma, Italy, Italy (NOT_YET_RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fracture Femur, Hip Arthroplasty Replacement, Total Hip Arthroplasty