Actively Recruiting
Cognitive and Motor Recovery in Frail Patients With Hip Fracture Using Digital Technology-Assisted Rehabilitation
Led by C.O.T. Cure Ortopediche Traumatologiche S.p.A. · Updated on 2026-03-13
30
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
Sponsors
C
C.O.T. Cure Ortopediche Traumatologiche S.p.A.
Lead Sponsor
F
Fondazione Don Carlo Gnocchi Onlus
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying elderly patients aged 65 to 89 who have had surgery for proximal femoral fracture to see if adding technology-based rehabilitation to standard therapy can improve cognitive and motor function better than conventional rehabilitation alone. This national, multicenter study also looks at how feasible it is to include technology-assisted rehab as a regular part of clinical care from the viewpoint of healthcare professionals. Participants will be randomly assigned to either receive conventional rehabilitation only, which involves joint mobilization, posture re-education, muscle strengthening, and walking training with assistive devices, or to an experimental group that combines conventional therapy with sensor-based digital rehabilitation devices for about one-third of their daily sessions. The rehab program includes 18 sessions over 3 to 4 weeks. Technology-assisted training provides real-time visual and auditory feedback to support motor and cognitive tasks and gait training. Participants will be evaluated before and after the rehab program using tests measuring mobility, cognitive status, pain, quality of life, and hip function. Blood samples will assess brain-derived neurotrophic factor (BDNF) levels and related genetics. Healthcare workers involved will report on their work quality related to the treatment methods. The main outcomes focus on changes in BDNF levels and mobility tests, with additional assessments of functional status and patient well-being throughout the study.
CONDITIONS
Brief Title
Cognitive and Physical Recovery After Hip Fracture in Frail Patients Using Digital Rehabilitation Technology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 65 and 89 years
- Underwent surgical treatment for proximal femur fracture, including total hip arthroplasty, partial hip arthroplasty, or intramedullary nailing
- Surgery performed within the last 15 days
- Clinically stable condition
- Admitted to rehabilitation wards eligible for rehabilitative therapy
You will not qualify if you...
- Age younger than 65 years or older than 90 years
- Refusal to give informed consent
- Behavioral or cognitive disorders limiting treatment compliance
- Mechanical instability of the surgical implant
- Clinical instability such as sepsis, severe anemia, or heart and lung failure
- Other fractures that prevent rehabilitation
- Severe uncorrectable visual impairments
- Pre-existing motor disabilities due to other systemic diseases
- Conditions preventing use of sensors, such as pacemaker, epilepsy, skin lesions, or severe allergies at device contact areas
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 4 weeks
Participants undergo a rehabilitation program after hip fracture surgery, receiving either conventional rehabilitation or integrated technology-assisted rehabilitation combining sensor-based digital devices with conventional therapy.
18 sessions delivered 5 to 6 times per week
Duration - Within 3 days after completion of rehabilitation
Participants complete clinical assessments to evaluate motor performance, functional outcomes, cognitive status, pain, quality of life, and blood tests to measure biomarkers related to recovery.
1 visit (in-person)
Trial Site Locations
Total: 2 locations
1
COT - Cure Ortopediche Traumatologiche
Messina, Italy, Italy, 98124
Actively Recruiting
2
Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza
Roma, Italy, Italy, 00166
Not Yet Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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