Effectiveness of Home-Based Exergame Motor-Cognitive Rehabilitation Versus Outpatient Multidisciplinary Rehabilitation in Individuals With Traumatic Brain Injury: A Pilot Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Disability Rating Scale (DRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of a home-based cognitive-motor telerehabilitation program in individuals with traumatic brain injury (TBI) following discharge from intensive inpatient neurorehabilitation.
The main questions it aims to answer are:
- Does home-based cognitive-motor telerehabilitation improve functional independence, cognitive performance, mobility, and quality of life in individuals with TBI?
- Are the effects of home-based cognitive-motor telerehabilitation superior to those achieved with standard outpatient rehabilitation?
The study will compare a home-based cognitive-motor telerehabilitation program with standard outpatient rehabilitation to determine their relative effects on functional recovery.
Participants will:
- Receive either home-based cognitive-motor telerehabilitation or standard outpatient rehabilitation, according to the assigned treatment pathway. Both rehabilitation programs consist of 20 sessions lasting 45 minutes each, three times per week.
- Undergo clinical, cognitive, and motor assessments at predefined study time points: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).
- Be evaluated for changes in functional independence, cognitive functioning, mobility, quality of life, and caregiver burden.
详细描述
Traumatic brain injury (TBI) is one of the leading causes of disability among young adults and is associated with a substantial economic burden on healthcare systems, as well as on patients and their families.
TBI may result in cognitive impairments, including deficits in attention, memory, and executive functions, as well as behavioral disturbances such as apathy, anxiety, and depression. In a smaller proportion of cases, motor dysfunctions, including gait and balance impairments, may also occur. These deficits negatively affect patients' independence and social participation and may also reduce caregivers' quality of life.
Conventional rehabilitation for individuals with TBI typically relies on multidisciplinary interventions, including cognitive training, physiotherapy, and occupational therapy. Although these approaches may improve specific functional domains, evidence supporting their effectiveness in enhancing overall independence and social participation remains limited. Therefore, there is a need to develop more targeted and personalized neurorehabilitation programs based on clinical, instrumental, and biological biomarkers, while ensuring continuity of care through integrated hospital-to-home rehabilitation pathways.
In the post-discharge setting, combined cognitive-motor rehabilitation has gained increasing attention due to the close interaction between motor and cognitive functions in everyday activities. In particular, telerehabilitation delivered through virtual reality-based exergames has shown promising results in improving mobility, cognitive performance, and functional independence in individuals with TBI. Compared with traditional face-to-face rehabilitation, which typically requires one-to-one therapist supervision, telerehabilitation enables patients to perform training at home through synchronous, asynchronous, or hybrid modalities, providing a more flexible and efficient model of care while reducing travel requirements and waiting times for rehabilitation services.
In light of the above, this pilot controlled, non-randomized, single-blind (assessor-blinded) clinical trial aims to investigate the effectiveness of home-based cognitive-motor telerehabilitation as a post-discharge continuity-of-care intervention compared with standard outpatient rehabilitation in individuals with traumatic brain injury (TBI) following discharge from intensive inpatient neurorehabilitation. We hypothesize that participants receiving the experimental intervention will demonstrate greater or at least comparable improvements in functional independence, cognitive performance, mobility, and quality of life than those receiving conventional outpatient rehabilitation, while also reducing caregiver burden.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The assessment will be administered by trained examiners non directly involved in the clinical trial.
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •TBI patients Inclusion Criteria
- •Discharge from intensive inpatient post-acute rehabilitation following a first traumatic brain injury (TBI).
- •Level of Cognitive Functioning Scale (LCF) score ≥ 6, indicating appropriate and goal-directed cognitive responses.
- •Ability to walk at least 30 meters, with or without an assistive device.
- •Ability to maintain an unsupported standing position for at least 3 minutes.
- •Provision of written informed consent.
- •TBI patients
排除标准
- •Diagnosis or suspected diagnosis of a neurodegenerative disorder.
- •Previous history of traumatic brain injury.
- •History of major psychiatric disorders (e.g., schizophrenia or bipolar disorder), primary sleep disorders, or epilepsy.
- •Severe visual or auditory impairment that could interfere with study assessments or participation in the rehabilitation program.
- •Severe expressive and/or receptive aphasia.
- •Language barriers preventing reliable cognitive assessment or informed consent procedures.
- •Current pregnancy.
- •Healthy Subjects - Exclusion Criteria
- •Presence of any neurological, sensrory, cognitive, psychiatric, cardiopulmonary, or musculoskeletal condition that may affect study participation or outcome measures
- •Language barriers preventing reliable cognitive assessment or informed consent procedures.
- •Current pregnancy.
研究组 & 干预措施
HOME-EXER: Motor-cognitive home-based telerehabilitation
Participants will receive a home-based motor-cognitive telerehabilitation program delivered through the Homing system (Tecnobody, Italy). The intervention consists of combined motor and cognitive exergames with real-time visual and auditory feedback, aimed at improving cognitive-motor integration during activities that simulate daily living tasks. The program includes 20 sessions (45 minutes per session) over 7 weeks (three sessions per week), consisting of one remotely supervised synchronous session and two self-administered asynchronous sessions per week. Training difficulty and exercise content may be remotely adjusted by the clinical team according to the participant's performance and rehabilitation needs.
干预措施: HOME-EXER telerehabilitation protocol (Other)
OUT-REHAB: Multidisciplinary Outpatient Rehabilitation
Participants will receive conventional multidisciplinary outpatient rehabilitation (usual care) following discharge from intensive inpatient neurorehabilitation. The program consists of individualized motor rehabilitation, cognitive rehabilitation, and occupational therapy delivered by qualified healthcare professionals. Treatment includes 20 sessions (45 minutes/session) over 7 weeks (three sessions per week), with rehabilitation activities tailored to each participant's clinical needs according to standard clinical practice.
干预措施: OUT-REHAB rehabilitation protocol (Other)
结局指标
主要结局
Disability Rating Scale (DRS)
时间窗: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0)
The Disability Rating Scale (DRS) is a validated measure of global functional disability after traumatic brain injury. It assesses impairment, disability, and participation restrictions across domains of consciousness, self-care, dependence, and psychosocial functioning. Scores range from 0 to 29, with higher scores indicating greater disability.
次要结局
- Montreal Cognitive Assessment (MoCA)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Symbol Digit Modalities Test (SDMT)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- California Verbal Learning Test II (CVLT-II)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Brief Visuospatial Memory Test - Revised (BVMT-R)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Hospital Anxiety and Depression Scale (HADS)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Berg Balance Scale (BBS)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Six-Minute Walk Test (6MWT)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Timed Up and Go (TUG) Test(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- EuroQol 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Quality Of Life After Brain Injury (QOLIBRI)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Community Integration Questionnaire (CIQ)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Caregiver Burden Inventory (CBI)(T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).)
- Adverse events(From T0 (hospital discharge, pre-intervention) to T2 (follow-up, 6 months after T0).)
研究者
Ilaria Carpinella
Principal Investigator
Fondazione Don Carlo Gnocchi ETS
