HOME-EXER telerehabilitation protocol: Participants will follow the HOME-EXER telerehabilitation protocol
OUT-REHAB rehabilitation protocol: Participants will follow the OUT-REHAB rehabilitation protocol
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
Accepted
TBI patients Inclusion Criteria
* Discharge from intensive inpatient post-acute rehabilitation following a first traumatic brain injury (TBI).
* 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.
TBI patients Exclusion Criteria
* 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.
* Severe expressive and/or receptive aphasia.
* Language barriers preventing reliable cognitive assessment or informed consent procedures.
* Current pregnancy.
Healthy Subjects - Exclusion Criteria
* Presence of any neurological, sensrory, cognitive, psychiatric, cardiopulmonary, or musculoskeletal condition that may affect study participation or outcome measures
* Language barriers preventing reliable cognitive assessment or informed consent procedures.
* Current pregnancy.
Primary outcome measure(s)
Disability Rating Scale (DRS) — T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0) 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.
Trial sites (2)
Facility
City
Region
Status
Istituto Auxologico Italiano IRCCS
Milan
Italy
IRCCS Fondazione Don Carlo Gnocchi ETS
Milan
Italy
More Fondazione Don Carlo Gnocchi ETS trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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