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.
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.
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.
Parallel
HOME-EXER telerehabilitation protocol
Other interventionParticipants will follow the HOME-EXER telerehabilitation protocol
OUT-REHAB rehabilitation protocol
Other interventionParticipants will follow the OUT-REHAB rehabilitation protocol
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.
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.
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.
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.
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.
Sex Data
Sex of participants, as reported in the medical record.
Age Data
Age of participants
Body Height
Participant's body height measured in centimeters (cm)
Body Weight
Participant's body weight measured in kilograms (kg)
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Fondazione Don Carlo Gnocchi ETS
Lead sponsor
Istituto Auxologico Italiano
Collaborator
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