About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HOME-EXER telerehabilitation protocol
- OUT-REHAB rehabilitation protocol
Treatment groups
Sponsors and collaborators
Fondazione Don Carlo Gnocchi ETS
Lead sponsor
Istituto Auxologico Italiano
Collaborator