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NCT07733336

Overview

NCT ID: NCT07733336
Lead Sponsor: Fondazione Don Carlo Gnocchi ETSOTHER
Official Title: Effectiveness of Home-Based Exergame Motor-Cognitive Rehabilitation Versus Outpatient Multidisciplinary Rehabilitation in Individuals With Traumatic Brain Injury: A Pilot Controlled Trial
Brief 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 29, 2026Actual
Start Date: Nov 3, 2026Estimated
Primary Completion Date: Mar 31, 2029Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: Ilaria CarpinellaContact
icarpinella@dongnocchi.it+390240308315

Similar Studies

Participant Group/Arms

HOME-EXER: Motor-cognitive home-based telerehabilitationExperimental

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.

Other: HOME-EXER telerehabilitation protocol

OUT-REHAB: Multidisciplinary Outpatient RehabilitationActive Comparator

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.

Other: OUT-REHAB rehabilitation protocol