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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Participants will follow the HOME-EXER telerehabilitation protocol
Participants will follow the OUT-REHAB rehabilitation protocol
Istituto Auxologico Italiano IRCCS
Milan, Italy, Italy
IRCCS Fondazione Don Carlo Gnocchi ETS
Milan, Italy, Italy
Disability Rating Scale (DRS)
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.
Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0)
Montreal Cognitive Assessment (MoCA)
A validated screening tool used to assess global cognitive functioning. Total scores range from 0 to 30, with higher scores indicating better cognitive performance.
Time frame: 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)
A validated neuropsychological test used to assess information processing speed, attention, and visual scanning. Participants are required to match symbols with corresponding numbers according to a reference key within 90 seconds. The score consists of the number of correct symbol-digit pairings completed in 90 seconds, with higher scores indicating better cognitive performance and faster processing speed.
Time frame: 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)
A validated neuropsychological test used to assess verbal learning and memory. A list of words is read aloud over five consecutive trials, and after each presentation participants are asked to freely recall as many words as possible. The score consists of the total number of correctly recalled words across the five learning trials, with higher scores indicating better verbal learning and memory performance.
Time frame: 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)
A validated neuropsychological test used to assess visuospatial learning and memory. Participants are shown a display containing six geometric figures for 10 seconds and are then asked to reproduce them from memory. This procedure is repeated over three learning trials. The score consists of the total number of points obtained across the three recall trials, based on the accuracy and location of the reproduced figures, with higher scores indicating better visuospatial learning and memory performance.
Time frame: 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)
A validated self-report questionnaire used to assess symptoms of anxiety and depression in medical and rehabilitation settings. The scale consists of 14 items, divided into two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each comprising 7 items. Scores for each subscale range from 0 to 21, with higher scores indicating greater levels of anxiety or depressive symptoms. The total HADS score ranges from 0 to 42.
Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).
Berg Balance Scale (BBS)
A validated clinical scale used to assess functional balance. The assessment consists of 14 functional tasks involving sitting, standing, transfers, reaching, turning, and single-leg stance. Each item is scored from 0 to 4, with a total score ranging from 0 to 56. Higher scores indicate better balance performance. Kinematic data will be recorded by an inertial sensor on lower back.
Time frame: 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)
A validated test used to assess walking capacity and endurance. Participants are instructed to walk as far as possible along a 30-meter corridor for 6 minutes, with rest periods and walking aids allowed if necessary. The outcome measure is the total distance walked in 6 minutes, with greater distances indicating better walking capacity and endurance. Kinematic data will be recorded by three inertial sensors on lower back and feet.
Time frame: 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
A validated measure of functional mobility and dynamic balance that assesses the time required for a participant to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. The test is administered under both single-task and cognitive dual-task conditions. In the dual-task condition (TUG-DT), participants perform the TUG while simultaneously completing a cognitive task consisting of generating alternating letters of the alphabet during walking. Outcome measures include completion time (seconds), and the Dual-Task Cost (DTC) for motor and cognitive performance, calculated as the percentage change between single-task and dual-task conditions. Lower completion times and lower DTC values indicate better functional mobility and dual-task ability. Kinematic data will be recorded by an inertial sensor on lower back.
Time frame: 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)
A validated self-report measure of health-related quality of life, used for clinical and economic appraisal. The questionnaire assesses five dimensions of health status: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels of severity ranging from no problems to extreme problems. Responses are converted into a health utility index score, with higher scores indicating better perceived health status. The instrument also includes a Visual Analogue Scale (EQ VAS) ranging from 0 (worst imaginable health) to 100 (best imaginable health), on which participants rate their overall health.
Time frame: 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)
A validated, disease-specific self-report questionnaire designed to assess health-related quality of life in individuals with traumatic brain injury (TBI). The instrument evaluates six domains: cognition, self, daily life and autonomy, social relationships, emotions, and physical problems. Items are rated on a 5-point scale, and responses are combined to generate a total score ranging from 0 to 100, with higher scores indicating better perceived quality of life after brain injury.
Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).
Community Integration Questionnaire (CIQ)
A validated questionnaire used to assess community integration following acquired brain injury. The instrument evaluates participation in three domains: home integration, social integration, and productive activities (e.g., work, education, or volunteering). Scores from individual items are summed to generate a total score, typically ranging from 0 to 29, with higher scores indicating greater independence and community participation.
Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).
Caregiver Burden Inventory (CBI)
Caregiver Burden Inventory (CBI): A validated self-report questionnaire used to assess the multidimensional burden experienced by caregivers. The instrument consists of 24 items grouped into five domains: time-dependence burden, developmental burden, physical burden, social burden, and emotional burden. Each item is rated on a 5-point scale (0-4), yielding a total score ranging from 0 to 96, with higher scores indicating greater caregiver burden. The CBI is widely used to evaluate the impact of caregiving responsibilities on caregivers' well-being and daily functioning.
Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).
Adverse events
Organized reporting of adverse events occurring during the study
Time frame: From T0 (hospital discharge, pre-intervention) to T2 (follow-up, 6 months after T0).
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