Health TrialsbyHealthPanel

Motor and Cognitive Telerehabilitation for Acquired Brain Injury

ConditionAcquired Brain Injury
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAzienda USL Toscana Nord Ovest

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tele-rehabilitation

    Device

    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 Presence

    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.

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: Group Presence (GP)Experimental treatment 1 intervention
Group B: Group Tele-RehabilitationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Brief Neuropshychological Examination

Time frame
Pre-intervetion and immediately after 8 weeks of intervention
2

Flug Meyer Upper Extremity Scale

Time frame
Pre-intervetion and immediately after 8 weeks of intervention

Secondary outcomes

1

System Usability Scale

Time frame
Pre-intervetion and immediately after 8 weeks of intervention
2

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Azienda USL Toscana Nord Ovest

Lead sponsor

IRCCS Bonino Pulejo

Collaborator

Istituto S.Anna Crotone

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: