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

NCT07733336 | Not Yet Recruiting DMC

• 2 other identifiers: TRUSTMERF-2024-12379258
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury;; Telerehabilitation; motor function; cognitive function; multidisciplinary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Disability Rating Scale (DRS)

  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.

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0)

Secondary Outcomes (13)

• Montreal Cognitive Assessment (MoCA)

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).

• Symbol Digit Modalities Test (SDMT)

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).

• California Verbal Learning Test II (CVLT-II)

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).

• Brief Visuospatial Memory Test - Revised (BVMT-R)

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).

• Hospital Anxiety and Depression Scale (HADS)

  T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).

Other Outcomes (10)

• Sex Data

  T0 (hospital discharge, pre-intervention)

• Age Data

  T0 (hospital discharge, pre-intervention)

• Body Height

  Participant's body height measured in centimeters (cm)

Study Arms (2)

HOME-EXER: Motor-cognitive home-based telerehabilitation

EXPERIMENTAL

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 Rehabilitation

ACTIVE 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

Interventions

HOME-EXER telerehabilitation protocol OTHER

Participants will follow the HOME-EXER telerehabilitation protocol

HOME-EXER: Motor-cognitive home-based telerehabilitation

OUT-REHAB rehabilitation protocol OTHER

Participants will follow the OUT-REHAB rehabilitation protocol

OUT-REHAB: Multidisciplinary Outpatient Rehabilitation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi ETS: lead

Study Sites (2)

Istituto Auxologico Italiano IRCCS

Milan, Italy, 20122, Italy

Location

IRCCS Fondazione Don Carlo Gnocchi ETS

Milan, Italy, 20148, Italy

Location

Related Publications (11)

• Walker WC, Pickett TC. Motor impairment after severe traumatic brain injury: A longitudinal multicenter study. J Rehabil Res Dev. 2007;44(7):975-82. doi: 10.1682/jrrd.2006.12.0158.

  PMID: 18075954 BACKGROUND

• Riggio S. Traumatic brain injury and its neurobehavioral sequelae. Neurol Clin. 2011 Feb;29(1):35-47, vii. doi: 10.1016/j.ncl.2010.10.008.

  PMID: 21172569 BACKGROUND

• Manivannan S, Al-Amri M, Postans M, Westacott LJ, Gray W, Zaben M. The Effectiveness of Virtual Reality Interventions for Improvement of Neurocognitive Performance After Traumatic Brain Injury: A Systematic Review. J Head Trauma Rehabil. 2019 Mar/Apr;34(2):E52-E65. doi: 10.1097/HTR.0000000000000412.

  PMID: 30045223 BACKGROUND

• Kumar KS, Samuelkamaleshkumar S, Viswanathan A, Macaden AS. Cognitive rehabilitation for adults with traumatic brain injury to improve occupational outcomes. Cochrane Database Syst Rev. 2017 Jun 20;6(6):CD007935. doi: 10.1002/14651858.CD007935.pub2.

  PMID: 28631816 BACKGROUND

• Howe EI, Andelic N, Fure SCR, Roe C, Soberg HL, Hellstrom T, Spjelkavik O, Enehaug H, Lu J, Ugelstad H, Lovstad M, Aas E. Cost-effectiveness analysis of combined cognitive and vocational rehabilitation in patients with mild-to-moderate TBI: results from a randomized controlled trial. BMC Health Serv Res. 2022 Feb 12;22(1):185. doi: 10.1186/s12913-022-07585-3.

  PMID: 35151285 BACKGROUND

• Herold F, Hamacher D, Schega L, Muller NG. Thinking While Moving or Moving While Thinking - Concepts of Motor-Cognitive Training for Cognitive Performance Enhancement. Front Aging Neurosci. 2018 Aug 6;10:228. doi: 10.3389/fnagi.2018.00228. eCollection 2018.

  PMID: 30127732 BACKGROUND

• D'Ippolito M, Aloisi M, Azicnuda E, Silvestro D, Giustini M, Verni F, Formisano R, Bivona U. Changes in Caregivers Lifestyle after Severe Acquired Brain Injury: A Preliminary Investigation. Biomed Res Int. 2018 Jul 3;2018:2824081. doi: 10.1155/2018/2824081. eCollection 2018.

  PMID: 30065934 BACKGROUND

• Calabro RS, Bonanno M, Torregrossa W, Cacciante L, Celesti A, Rifici C, Tonin P, De Luca R, Quartarone A. Benefits of Telerehabilitation for Patients With Severe Acquired Brain Injury: Promising Results From a Multicenter Randomized Controlled Trial Using Nonimmersive Virtual Reality. J Med Internet Res. 2023 Aug 21;25:e45458. doi: 10.2196/45458.

  PMID: 37490017 BACKGROUND

• Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.

  PMID: 26537996 BACKGROUND

• Avramovic P, Rietdijk R, Attard M, Kenny B, Power E, Togher L. Cognitive and Behavioral Digital Health Interventions for People with Traumatic Brain Injury and Their Caregivers: A Systematic Review. J Neurotrauma. 2023 Feb;40(3-4):159-194. doi: 10.1089/neu.2021.0473. Epub 2022 Aug 29.

  PMID: 35819294 BACKGROUND

• Alashram AR, Padua E, Annino G. Virtual reality for balance and mobility rehabilitation following traumatic brain injury: A systematic review of randomized controlled trials. J Clin Neurosci. 2022 Nov;105:115-121. doi: 10.1016/j.jocn.2022.09.012. Epub 2022 Sep 28.

  PMID: 36182811 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Ilaria Carpinella

CONTACT

+390240308315; icarpinella@dongnocchi.it

Angela Comanducci

CONTACT

acomanducci@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment will be administered by trained examiners non directly involved in the clinical trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Pilot controlled, non-randomized, single-blind (assessor-blinded) clinical trial

Study Record Dates

• First Submitted: July 22, 2026
• First Posted: July 29, 2026
• Study Start (Estimated): November 3, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2029
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Preliminary data will be available at the end of the study
• Access Criteria: at request to the Principal investigator

Locations

IT (2)