Motor and Cognitive Telerehabilitation for Acquired Brain Injury (TELEGCA)

January 27, 2026 updated by: Federico Posteraro, Azienda USL Toscana Nord Ovest
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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 -

Exclusion Criteria:

  • 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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group Presence (GP)
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.
Device: Group Presence
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.
Active Comparator: Group Tele-Rehabilitation
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.
Device: Tele-rehabilitation
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Brief Neuropshychological Examination
Time Frame: Pre-intervetion and immediately after 8 weeks of intervention
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
Pre-intervetion and immediately after 8 weeks of intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
System Usability Scale
Time Frame: Pre-intervetion and immediately after 8 weeks of intervention
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
Pre-intervetion and immediately after 8 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda USL Toscana Nord Ovest

Collaborators

Istituto S.Anna Crotone
IRCCS Bonino Pulejo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

January 19, 2026

First Submitted That Met QC Criteria

January 27, 2026

First Posted (Actual)

February 4, 2026

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUSL Toscana Nord Ovest

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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