The aim of this study is to evaluate whether integrating a technology-based rehabilitation approach with conventional therapies in the rehabilitation of patients with proximal femoral fracture may be advantageous compared with conventional therapy alone. Specifically, the objective is to assess whether the addition of technology-assisted rehabilitation can improve cognitive function, in addition to motor function and overall abilities, compared with conventional rehabilitation alone. Furthermore, the study intends to explore the feasibility of implementing technology-assisted rehabilitation as a stable and routine component of everyday clinical practice, also considering the perspective of healthcare professionals.
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
Age > 90 years
Age < 65 years
Refusal to sign the informed consent form
Behavioral or cognitive disorders limiting compliance with the rehabilitative treatment
Parallel
Experimental intervention - integrated treatment with a sensor-based device
DeviceThe technology/robotic group will perform one-third (1/3) of the daily rehabilitation using technology-assisted devices and two-thirds (2/3) using conventional rehabilitation. In addition to the conventional rehabilitation described below, the treatment will include technology-assisted rehabilitation consisting of facilitated active joint mobilization exercises with visual and auditory feedback, aimed at stimulating motor and cognitive functions, as well as gait training.
Conventional rehabilitation intervention
Other interventionThe conventional rehabilitation programme includes assisted and facilitated joint mobilization exercises to improve range of motion; exercises for postural readaptation of the trunk to the upright position; isometric exercises; and gait training using a 4-wheeled walker or forearm crutches (Canadian crutches), aimed at improving walking ability and achieving an appropriate recovery of the gait pattern.
Changes in serum BDNF levels
Difference in serum brain-derived neurotrophic factor (BDNF) levels between baseline and the end of the rehabilitative treatment, assessed to evaluate biomolecular changes associated with neuroplasticity.
Change in Timed Up and Go test
Difference in functional mobility, balance, and gait performance assessed using the Timed Up and Go test between baseline and end of rehabilitative treatment.
Change in Timed Up and Go Dual Task test
Difference in cognitive-motor dual-task performance assessed using the Timed Up and Go Dual Task test between baseline and end of rehabilitative treatment.
Change in the Harris Hip Score (HHS)
Change in hip function, pain, and functional ability as assessed by the Harris Hip Score, a clinician-administered outcome measure ranging from 0 to 100 points, where higher scores indicate better hip function, assessed at baseline and at the end of the rehabilitative treatment.
Change in the modified Barthel Index
Change in independence in activities of daily living as assessed by item-level scores of the Barthel Index, a validated measure of functional independence ranging from 0 to 100 points, where higher scores indicate greater independence, assessed at baseline and at the end of the rehabilitative treatment (Italian version, 2015).
Change in pain intensity measured by the Numeric Rating Scale (NRS)
Change in pain intensity as assessed by the Numeric Rating Scale, a patient-reported outcome measure ranging from 0 to 10, where higher scores indicate greater pain intensity, assessed at baseline and at the end of the rehabilitative treatment.
Change in quality of life measured by the SF-36
Change in health-related quality of life as assessed by the 36-Item Short Form Health Survey (SF-36), a validated patient-reported outcome measure composed of multiple domains, each scored on a 0 to 100 scale, where higher scores indicate better health-related quality of life, assessed at baseline and at the end of the rehabilitative treatment.
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C.O.T. Cure Ortopediche Traumatologiche S.p.A.
Lead sponsor
Fondazione Don Carlo Gnocchi Onlus
Collaborator
