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NCT07733336
Home-Based Exergame Motor-Cognitive Rehabilitation for Traumatic Brain Injury
Conditions: Traumatic Brain Injury
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Fondazione Don Carlo Gnocchi ETS
Location: Istituto Auxologico Italiano IRCCS Milan Italy
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 Criteria
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.
Source: ClinicalTrials.gov (NCT07733336). StuddyBuddy aggregates publicly available trial information.