Motor and Cognitive Telerehabilitation for Acquired Brain Injury (TELEGCA)

Azienda USL Toscana Nord Ovest

Status: Not yet enrolling

Conditions: Acquired Brain Injury

Treatments: Device: Tele-rehabilitation; Device: Group Presence

Study type: Interventional

Funder types: Other

Identifiers

NCT07386314

AUSL Toscana Nord Ovest

Details and patient eligibility

About

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.

Full 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.

Enrollment: 62 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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62 participants in 2 patient groups

Group Presence (GP)

Experimental group

Description:

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.

Treatment:

Device: Group Presence

Group Tele-Rehabilitation

Active Comparator group

Description:

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.

Treatment:

Device: Tele-rehabilitation