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

Sponsor
Fondazione Don Carlo Gnocchi ETS
Study ID
NCT07733336
Status
Not Yet Recruiting

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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • HOME-EXER telerehabilitation protocol — OTHER
    Participants will follow the HOME-EXER telerehabilitation protocol
  • OUT-REHAB rehabilitation protocol — OTHER
    Participants will follow the OUT-REHAB rehabilitation protocol

Study Details

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.

Key Dates

First listed
Jul 29, 2026
Start date
Nov 3, 2026
Status verified
Jul 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Disability Rating Scale (DRS) [ Time Frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0) ]

Central Contacts

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