Motor and Cognitive Telerehabilitation for Acquired Brain Injury
TELEGCA
1 other identifier
interventional
62
0 countries
N/A
Brief Summary
The overall objective of the study is to compare upper limb cognitive and motor rehabilitation programs delivered via tele-rehabilitation and in-person, in order to evaluate their overall impact on the rehabilitation process of subjects with GCA outcomes at the end of the subacute phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2026
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2026
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedFirst Posted
Study publicly available on registry
February 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
February 4, 2026
January 1, 2026
10 months
January 19, 2026
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Brief Neuropshychological Examination
Pre-intervetion and immediately after 8 weeks of intervention
Flug Meyer Upper Extremity Scale
Pre-intervetion and immediately after 8 weeks of intervention
Secondary Outcomes (2)
System Usability Scale
Pre-intervetion and immediately after 8 weeks of intervention
Client Satisfaction Questionnaire-8 Total scores range from 8 to 32, with the higher number indicating greater satisfaction
Pre-intervetion and immediately after 8 weeks of intervention
Study Arms (2)
Group Presence (GP)
EXPERIMENTALPatients in the in-person treatment group (GP) will undergo 50-minute sessions, three times a week, for a total of eight weeks using VRRS virtual reality systems (Khymeia, Padua, Italy), certified Class A medical devices.
Group Tele-Rehabilitation
ACTIVE COMPARATORThe telerehabilitation treatment group (GT) will receive a similar motor and cognitive treatment program at home using the VRRS HomeKit device (Khymeia, Padua, Italy), another certified Class 1 medical device.
Interventions
The telerehabilitation treatment group (GT) will receive a similar motor and cognitive treatment program at home using the VRRS HomeKit device (Khymeia, Padua, Italy), another certified Class 1 medical device.
Patients in the in-person treatment group (GP) will undergo 50-minute sessions, three times a week, for a total of eight weeks using VRRS virtual reality systems (Khymeia, Padua, Italy), certified Class 1 medical devices. The first four weeks of treatment will be conducted with VRRS EVO, while the following four weeks will be conducted with VRRS Physio, with exercises designed to improve various cognitive and motor domains of the upper limb.
Eligibility Criteria
You may qualify if:
- Outcome of Severe Acquired Brain Injury (GAI) of various etiologies;
- Age between 18 and 75 years
- Level of Cognitive Functioning (LCF) at discharge from the hospital ward \>= 6;
- One or more neuropsychological deficits in the areas of attention, memory, language, and executive functions;
- Possible upper limb motor deficit;
- Absence of general clinical complications that could interfere with rehabilitation treatment;
- Cognitive and language functions sufficient to understand the instructions provided and give consent -
You may not qualify if:
- Level of Cognitive Functioning (LCF) at discharge from hospitalization ward \< 6;
- Presence of previous deficits in neuropsychological and motor functions prior to the acute event;
- Vulnerable subjects or those in emergency situations
- Failure to provide informed consent.
- Pregnant or intending to become pregnant during the enrollment period -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Istituto S.Anna Crotonecollaborator
- Azienda USL Toscana Nord Ovestlead
- IRCCS Bonino Pulejocollaborator
Related Publications (3)
Maggio MG, Rizzo A, De Francesco M, Barbera M, Kamran M, De Luca R, Corallo F, Quartarone A, Calabro RS. What About the Differences in Body Representation and Body Image Between Stroke Patients and Healthy Controls? Psychological and Clinical Implications. Brain Behav. 2025 May;15(5):e70155. doi: 10.1002/brb3.70155.
PMID: 40342223BACKGROUNDMaggio MG, Bonanno L, Rizzo A, Barbera M, Benenati A, Impellizzeri F, Corallo F, De Luca R, Quartarone A, Calabro RS. The role of virtual reality-based cognitive training in enhancing motivation and cognitive functions in individuals with chronic stroke. Sci Rep. 2025 Jul 12;15(1):25258. doi: 10.1038/s41598-025-08173-1.
PMID: 40652006BACKGROUNDDe Luca R, Calderone A, Gangemi A, Rifici C, Bonanno M, Maggio MG, Cappadona I, Veneziani I, Ielo A, Corallo F, Quartarone A, Cardile D, Calabro RS. Is Virtual Reality Orientation Therapy Useful to Optimize Cognitive and Behavioral Functioning Following Severe Acquired Brain Injury? An Exploratory Study. Brain Sci. 2024 Apr 23;14(5):410. doi: 10.3390/brainsci14050410.
PMID: 38790389BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of rehabilitation department Versilia Hospital
Study Record Dates
First Submitted
January 19, 2026
First Posted
February 4, 2026
Study Start
February 1, 2026
Primary Completion (Estimated)
November 30, 2026
Study Completion (Estimated)
November 30, 2026
Last Updated
February 4, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share