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

Official title

Effectiveness of Home-Based Exergame Motor-Cognitive Rehabilitation Versus Outpatient Multidisciplinary Rehabilitation in Individuals With Traumatic Brain Injury: A Pilot Controlled Trial

Overview

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.

Detailed description

Traumatic brain injury (TBI) is one of the leading causes of disability among young adults and is associated with a substantial economic burden on healthcare systems, as well as on patients and their families.

TBI may result in cognitive impairments, including deficits in attention, memory, and executive functions, as well as behavioral disturbances such as apathy, anxiety, and depression. In a smaller proportion of cases, motor dysfunctions, including gait and balance impairments, may also occur. These deficits negatively affect patients' independence and social participation and may also reduce caregivers' quality of life.

Conventional rehabilitation for individuals with TBI typically relies on multidisciplinary interventions, including cognitive training, physiotherapy, and occupational therapy. Although these approaches may improve specific functional domains, evidence supporting their effectiveness in enhancing overall independence and social participation remains limited. Therefore, there is a need to develop more targeted and personalized neurorehabilitation programs based on clinical, instrumental, and biological biomarkers, while ensuring continuity of care through integrated hospital-to-home rehabilitation pathways.

In the post-discharge setting, combined cognitive-motor rehabilitation has gained increasing attention due to the close interaction between motor and cognitive functions in everyday activities. In particular, telerehabilitation delivered through virtual reality-based exergames has shown promising results in improving mobility, cognitive performance, and functional independence in individuals with TBI. Compared with traditional face-to-face rehabilitation, which typically requires one-to-one therapist supervision, telerehabilitation enables patients to perform training at home through synchronous, asynchronous, or hybrid modalities, providing a more flexible and efficient model of care while reducing travel requirements and waiting times for rehabilitation services.

In light of the above, this pilot controlled, non-randomized, single-blind (assessor-blinded) clinical trial aims to investigate the effectiveness of home-based cognitive-motor telerehabilitation as a post-discharge continuity-of-care intervention compared with standard outpatient rehabilitation in individuals with traumatic brain injury (TBI) following discharge from intensive inpatient neurorehabilitation. We hypothesize that participants receiving the experimental intervention will demonstrate greater or at least comparable improvements in functional independence, cognitive performance, mobility, and quality of life than those receiving conventional outpatient rehabilitation, while also reducing caregiver burden.

Interventions

• Other HOME-EXER telerehabilitation protocol
  Participants will follow the HOME-EXER telerehabilitation protocol
• Other OUT-REHAB rehabilitation protocol
  Participants will follow the OUT-REHAB rehabilitation protocol

Primary outcome measures

• Disability Rating Scale (DRS) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0)]

Secondary outcome measures (12)

• Montreal Cognitive Assessment (MoCA) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: 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) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Berg Balance Scale (BBS) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Six-Minute Walk Test (6MWT) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Timed Up and Go (TUG) Test [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• EuroQol 5-Dimensions 5-Levels Health Questionnaire (EQ-5D-5L) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Quality Of Life After Brain Injury (QOLIBRI) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Community Integration Questionnaire (CIQ) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]
• Caregiver Burden Inventory (CBI) [Time frame: T0 (hospital discharge, pre-intervention), T1 (post-intervention, 7 weeks after T0), and T2 (follow-up, 6 months after T0).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Italy · 2 centers

• Istituto Auxologico Italiano IRCCS — Milan
• IRCCS Fondazione Don Carlo Gnocchi ETS — Milan

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT07733336 · TRUSTME · RF-2024-12379258 · RF-2024-12379258

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗