Cognitive and Motor Recovery in Frail Patients With Hip Fracture: Effectiveness of Digital Technology-Assisted Rehabilitation and Analysis of Biomolecular Mechanisms
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in serum BDNF levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Conventional Rehabilitation
Patients receive a standard inpatient conventional rehabilitation program including joint mobilization, postural re-education, muscle strengthening, and gait training with assistive devices.
干预措施: 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).
干预措施: Experimental intervention - integrated treatment with a sensor-based device (Device)
结局指标
主要结局
Changes in serum BDNF levels
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Ennio Ferlazzo
Head of Rehabilitation Department
C.O.T. Cure Ortopediche Traumatologiche S.p.A.