Clinical Trial

Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury

Study acronym: HOME-TBI
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07733336
Lead Sponsor Fondazione Don Carlo Gnocchi ETS
Collaborators: Istituto Auxologico Italiano
Conditions Traumatic Brain Injury
Enrollment 30 participants
Start Date 2026-11-03
Primary Completion 2029-03-31 (estimated)
Study Completion 2029-03-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-11