Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- C.O.T. Cure Ortopediche Traumatologiche S.p.A.
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Changes in serum BDNF levels
Overview
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.
Detailed Description
This is a national, multicenter, non-profit, post-market interventional longitudinal clinical study designed to evaluate the effectiveness of integrating technology-assisted rehabilitation with conventional rehabilitation in elderly patients undergoing inpatient rehabilitation after surgically treated proximal femoral fracture.
Eligible participants aged 65 to 89 years who have undergone surgical treatment for proximal femoral fracture (total hip arthroplasty, partial hip arthroplasty, or intramedullary nailing) and who are clinically stable will be enrolled during their inpatient rehabilitation stay. After enrollment, patients will be randomly assigned to one of two treatment arms: (1) conventional rehabilitation alone (control group) or (2) integrated rehabilitation combining conventional therapy with sensor-based technology-assisted rehabilitation (experimental group). Randomization will be centralized and stratified by center and age group.
The total rehabilitation program consists of 18 sessions delivered over approximately 3-4 weeks, with a frequency of 5-6 sessions per week. Patients in the experimental group will perform approximately one-third of daily rehabilitation sessions using sensor-based digital devices providing real-time visual and auditory feedback, and two-thirds with conventional rehabilitation. Technology-assisted training includes facilitated active joint mobilization, motor and cognitive stimulation tasks, and gait training. The control group will receive conventional rehabilitation only, including assisted joint mobilization, postural re-education, muscle strengthening exercises, and gait training with assistive devices.
Clinical assessments will be performed at baseline (T0) and at the end of the rehabilitation program (T1). Motor performance will be assessed using the Timed Up and Go (TUG) test, which measures the time required for a participant to stand up from a chair, walk three meters, turn around, walk back, and sit down, as well as the Timed Up and Go Dual Task (TUG Dual Task), which evaluates mobility under simultaneous cognitive or motor task conditions. Additional functional outcomes include the Harris Hip Score, Barthel Index, pain assessed by Numeric Rating Scale, and health-related quality of life assessed by the SF-36. Cognitive status will be assessed using the Mini-Mental State Examination (MMSE). Blood samples will be collected at T0 and T1 to measure serum brain-derived neurotrophic factor (BDNF) levels and to analyze the rs6265 (Val66Met) polymorphism.
The primary endpoints are the change in serum BDNF levels and the change in TUG and TUG Dual Task performance from baseline to the end of treatment. Secondary endpoints include changes in functional scores, pain, quality of life, and exploratory analysis of the BDNF genetic polymorphism.
Healthcare professionals involved in the rehabilitation program will also complete the Work-Related Quality of Life (WRQoL) questionnaire to explore the perceived impact of technology-assisted rehabilitation on work-related quality of life.
Statistical analysis will be performed to evaluate differences between the control and experimental groups and changes over time in outcome measures. A p-value < 0.05 will be considered statistically significant.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to 89 Years (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
Conventional Rehabilitation
Patients receive a standard inpatient conventional rehabilitation program including joint mobilization, postural re-education, muscle strengthening, and gait training with assistive devices.
Intervention: Conventional rehabilitation intervention (Other)
Technology-Assisted Integrated Rehabilitation
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).
Intervention: Experimental intervention - integrated treatment with a sensor-based device (Device)
Outcomes
Primary Outcomes
Changes in serum BDNF levels
Time Frame: Baseline and within 3 days after completion of the rehabilitative treatment
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
Time Frame: Baseline and within 3 days after completion of the rehabilitative treatment
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
Time Frame: Baseline and within 3 days after completion of the rehabilitative treatment
Difference in cognitive-motor dual-task performance assessed using the Timed Up and Go Dual Task test between baseline and end of rehabilitative treatment.
Secondary Outcomes
- 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)
- Analysis of the rs6265 polymorphism (Val66Met mutation) of the BDNF gen(Baseline)
- Change in quality of life measured by the SF-36(Baseline and within 3 days after completion of the rehabilitative treatment)
- Healthcare professionals' perspective on work-related quality of work in the two different treatment approaches.(At the end of treatment delivery for both interventions)
Investigators
Ennio Ferlazzo
Head of Rehabilitation Department
C.O.T. Cure Ortopediche Traumatologiche S.p.A.