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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07733336). StuddyBuddy aggregates publicly available trial information.