Acquired Brain InjuryTELEGCANCT07386314
Motor and Cognitive Telerehabilitation for Acquired Brain Injury
A study testing Tele-rehabilitation and Group Presence in people with Acquired Brain Injury, run by Azienda USL Toscana Nord Ovest.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Tele-rehabilitation and Group Presence
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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 -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
The study is a controlled clinical trial aimed at evaluating the efficacy and feasibility of cognitive and motor rehabilitation programs delivered in person or via tele-rehabilitation. Sixty-two subjects, aged 18 to 75, of both sexes, will be consecutively enrolled at the three participating centers. The sample size was calculated assuming a change of 15 points (standard deviation 20) on the Brief Neuropsychological Examination (BNE), with alpha = 0.05, beta = 0.2, and a power of 80%. A 10% margin was added to the resulting number (28 subjects per group) for potential dropouts. The ENB was chosen as the primary measure because, validated in the Italian population, it allows for a comprehensive, multidomain assessment that is sensitive to changes in the main cognitive domains (attention, memory, language, executive and praxic functions), also allowing for the evaluation of treatment efficacy over time, with short administration times and good tolerability in patients with GCA outcomes. Recent multicenter studies have confirmed its reliability and clinical relevance in this population. Subjects will be assigned to two treatment groups using block randomization, stratified by age, gender, and baseline functional level. This procedure was adopted to reduce potential bias and ensure greater comparability between groups. However, a geographical restriction will be maintained: patients unable to physically access the facility will be included in the tele-rehabilitation group (TG), but will follow the same stratification and randomization procedure, ensuring methodological consistency and allowing for dedicated sensitivity analyses.
The in-person treatment group (GP) will complete 50-minute sessions, three times a week for eight weeks, at the rehabilitation center. The tele-rehabilitation treatment group (TG) will complete a similar program at home, with the same frequency and duration, via dedicated platforms.
Sixty-two subjects (18-75 years old, both genders) will be consecutively enrolled at the three participating centers upon discharge from hospital rehabilitation. Patients will be assigned equally to the two groups (in-person treatment and tele-rehabilitation) using block randomization stratified by age, gender, and functional level.
- Conditions
- Acquired Brain Injury
- Being tested
- Tele-rehabilitation, Group Presence
- Keywords
- Brain Injury, tele-rehabilitation, motor, cognitive
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-rehabilitationDevice
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.
Group PresenceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group Presence (GP) | Experimental | 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 A medical devices. Receives: Device: Group Presence |
| Group Tele-Rehabilitation | Active comparator | 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. Receives: Device: Tele-rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Neuropshychological Examination
Measured: Pre-intervetion and immediately after 8 weeks of intervention
Flug Meyer Upper Extremity Scale
Measured: Pre-intervetion and immediately after 8 weeks of intervention
Secondary outcomes (2)
System Usability Scale
Measured: 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
Measured: Pre-intervetion and immediately after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Toscana Nord Ovest
- Sponsor type
- University, hospital or other
- Collaborators
- IRCCS Bonino Pulejo, Istituto S.Anna Crotone
- Responsible party
- Principal investigator, Federico Posteraro, Azienda USL Toscana Nord Ovest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386314
- Sponsor's protocol ID
- AUSL Toscana Nord Ovest
- Acronym
- TELEGCA
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40342223Maggio 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.
PubMed 40652006De 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.
PubMed 38790389
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motor and Cognitive Telerehabilitation for Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT07386314
- Acronym / sponsor ID
- TELEGCA / AUSL Toscana Nord Ovest
- Conditions
- Acquired Brain Injury
- Keywords
- Brain Injury, tele-rehabilitation, motor, cognitive
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Azienda USL Toscana Nord OvestUniversity, hospital or other
- Collaborators
- IRCCS Bonino Pulejo, Istituto S.Anna Crotone
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is a controlled clinical trial aimed at evaluating the efficacy and feasibility of cognitive and motor rehabilitation programs delivered in person or via tele-rehabilitation. Sixty-two subjects, aged 18 to 75, of both sexes, will be consecutively enrolled at the three participating centers. The sample size was calculated assuming a change of 15 points (standard deviation 20) on the Brief Neuropsychological Examination (BNE), with alpha = 0.05, beta = 0.2, and a power of 80%. A 10% margin was added to the resulting number (28 subjects per group) for potential dropouts. The ENB was chosen as the primary measure because, validated in the Italian population, it allows for a comprehensive, multidomain assessment that is sensitive to changes in the main cognitive domains (attention, memory, language, executive and praxic functions), also allowing for the evaluation of treatment efficacy over time, with short administration times and good tolerability in patients with GCA outcomes. Recent multicenter studies have confirmed its reliability and clinical relevance in this population. Subjects will be assigned to two treatment groups using block randomization, stratified by age, gender, and baseline functional level. This procedure was adopted to reduce potential bias and ensure greater comparability between groups. However, a geographical restriction will be maintained: patients unable to physically access the facility will be included in the tele-rehabilitation group (TG), but will follow the same stratification and randomization procedure, ensuring methodological consistency and allowing for dedicated sensitivity analyses.
The in-person treatment group (GP) will complete 50-minute sessions, three times a week for eight weeks, at the rehabilitation center. The tele-rehabilitation treatment group (TG) will complete a similar program at home, with the same frequency and duration, via dedicated platforms.
Sixty-two subjects (18-75 years old, both genders) will be consecutively enrolled at the three participating centers upon discharge from hospital rehabilitation. Patients will be assigned equally to the two groups (in-person treatment and tele-rehabilitation) using block randomization stratified by age, gender, and functional level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Presence (GP) | Experimental | Device: Group PresencePatients 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 comparator | Device: Tele-rehabilitationThe 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (5 listed)
- 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 -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-rehabilitationThe 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. | Device | Group Tele-Rehabilitation |
| Group PresencePatients 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. | Device | Group Presence (GP) |
Primary outcome
Brief Neuropshychological Examination
Time frame: Pre-intervetion and immediately after 8 weeks of intervention
Flug Meyer Upper Extremity Scale
Time frame: Pre-intervetion and immediately after 8 weeks of intervention
2 secondary outcomes
System Usability Scale
Time frame: 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
Time frame: Pre-intervetion and immediately after 8 weeks of intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Background: PubMed 40342223Maggio 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.
- Background: PubMed 40652006Maggio 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.
- Background: PubMed 38790389De 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Acquired Brain Injury
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
RecruitingPhase 2
Study on Thiamine Supplementation to REduce braiN Injury Associated With Chronic Alcohol Use in Outpatients With Alcohol Use Disorder
Alcohol Use Disorder
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-rehabilitation and Group Presence in people with Acquired Brain Injury, run by Azienda USL Toscana Nord Ovest.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Federico Posteraro (+3905746057061, federico.posteraro@uslnordovest.toscana.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brief Neuropshychological Examination (time frame: Pre-intervetion and immediately after 8 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07386314, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.