RecruitingNot ApplicableNCT07392515

Cognitive and Physical Recovery After Hip Fracture in Frail Patients Using Digital Rehabilitation Technology

Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms


Sponsor

C.O.T. Cure Ortopediche Traumatologiche S.p.A.

Enrollment

30 participants

Start Date

Feb 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 65 YearsMax Age: 89 Years

Inclusion Criteria5

  • 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 Criteria10

  • 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).

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Interventions

DEVICEExperimental intervention - integrated treatment with a sensor-based device

The 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.

OTHERConventional rehabilitation intervention

The 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.


Locations(2)

COT - Cure Ortopediche Traumatologiche

Messina, Italy, Italy

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, Italy, Italy

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NCT07392515


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