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

NCT07392515 | Recruiting

• 1 other identifier: PNC0000007-B53C22006770008
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Fracture Femur; Hip Arthroplasty Replacement; Total Hip Arthroplasty (THA)

Outcome Measures

Primary Outcomes (3)

• 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.

  Baseline and within 3 days after completion of the rehabilitative treatment

• 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.

  Baseline and within 3 days after completion of the 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.

  Baseline and within 3 days after completion of the rehabilitative treatment

Secondary Outcomes (6)

• Change in the Harris Hip Score (HHS)

  Baseline and within 3 days after completion of the rehabilitative treatment

• Change in the modified Barthel Index

  Baseline and within 3 days after completion of the rehabilitative treatment

• Change in pain intensity measured by the Numeric Rating Scale (NRS)

  Baseline and within 3 days after completion of the rehabilitative treatment

• Change in quality of life measured by the SF-36

  Baseline and within 3 days after completion of the rehabilitative treatment

• Analysis of the rs6265 polymorphism (Val66Met mutation) of the BDNF gen

  Baseline

Study Arms (2)

Conventional Rehabilitation

ACTIVE COMPARATOR

Patients receive a standard inpatient conventional rehabilitation program including joint mobilization, postural re-education, muscle strengthening, and gait training with assistive devices.

Other: Conventional rehabilitation intervention

Technology-Assisted Integrated Rehabilitation

EXPERIMENTAL

Patients receive an integrated rehabilitation program combining sensor-based technology-assisted training (1/3 of daily sessions) with conventional rehabilitation (2/3 of daily sessions).

Device: Experimental intervention - integrated treatment with a sensor-based device

Interventions

Conventional rehabilitation intervention OTHER

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.

Conventional Rehabilitation

Experimental intervention - integrated treatment with a sensor-based device 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.

Technology-Assisted Integrated Rehabilitation

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• C.O.T. Cure Ortopediche Traumatologiche S.p.A.: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator

Study Sites (2)

COT - Cure Ortopediche Traumatologiche

Messina, Italy, 98124, Italy

RECRUITING

Fondazione Don Carlo Gnocchi - Centro Santa Maria della Provvidenza

Roma, Italy, 00166, Italy

NOT YET RECRUITING

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Rehabilitation Department

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 6, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)