Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net (MENTE.NET Study)

IRCCS Eugenio Medea

Status: Completed

Conditions: Neurological Diseases or Conditions

Treatments: Device: Khymeia VRRS

Study type: Interventional

Funder types: Other

Identifiers

NCT06450717

850

Details and patient eligibility

About

This pilot study aims at networking the experience gained in neurorehabilitation of developmental neurodisabilities from the 3 poles of IRCCS Medea (Brindisi, Bosisio Parini, and Conegliano) to assess the feasibility of performing home-based telerehabilitation on cognitive and motor aspects through the Khymeia Virtual Reality Rehabilitation System (VRRS) platform.

Full description

Few studies report the efficacy of telerehabilitation treatments in developmental age. The results suggest that it could be a promising tool for neurorehabilitation.The present pilot study aims at networking the experience gained in neurorehabilitation of developmental neurodisabilities from the 3 poles of IRCCS Medea (Brindisi, Bosisio Parini, and Conegliano) to evaluate the feasibility of performing home-based TR on cognitive and motor aspects through the Khymeia VRRS platform. VRRS represents an innovative system for immersive and non-immersive virtual reality rehabilitation and telerehabilitation.

In view of recent developments in Information and Communication Technologies (ICT) and their applicability to the neurological evaluation and rehabilitation context, VRRS instrumentation may represent a suitable methodology to assess the feasibility of a rehabilitation and telerehabilitation protocol for patients with complex neurodisabilities in pediatric age.

The present pilot project involves the use of the VRRS technology platform and the use of exercises performed in a 3D virtual and non-3D virtual environment. Implementation in the virtual environment of the exercises allows the therapist to set up, graduate, and modulate the selected exercises in the platform. The playful aspects and continuous performance monitoring and evaluation are then a key aspect in the rehabilitation process, as they keep the patient's motivation high. Through Home Tablets delivered to the patient, the platform makes possible home telerehabilitation through the proposal of cognitive and motor activities in 2 modes, Online (in the presence of the therapist) and Offline.

In order to test the feasibility of cognitive-motor rehabilitation intervention protocols carried out through VRRS, 30 patients (10 per research center) will be recruited and treated by using the VRRS library exercises. The VRRS exercises will be chosen according to the specific rehabilitation needs of each participant.

The study is designed as a two-year multicenter prospective clinical-experimental pilot study. The project involves the initial small-scale application of a telerehabilitation study protocol to test whether the methodology is appropriate, establish its feasibility, and derive useful information for sample size calculation for subsequent randomized trials. For prospective data collection, patients will be consecutively enrolled at participating centers.

If the VRRS is confirmed to be a suitable tool for conducting cognitive and motor TR in this clinical population as well, the present study may set the stage for future efficacy studies.

Other objectives of the study are:

• to identify within the network telerehabilitation programs aimed at improving cognitive and motor functions in developmental-age individuals with neurodisabilities, identifying common modes of intervention;
• to collect a longitudinal data set through the use of specific assessment batteries on motor, cognitive and functional adaptation functions, including from the perspective of ICF, secondary complications, autonomy, participation and quality of life. As a pilot study, conduct initial analyses of the effectiveness of interventions in order to create useful data for sample size calculation for subsequent randomized trials;
• to provide health policy makers with better scientific evidence on telerehabilitation in order to plan interventions aimed at better utilization and enhancement of these methods;
• to highlight good practices related to telerehabilitation by proposing a series of evaluations and recommendations aimed at fostering further improvement in the quality of rehabilitation.

Enrollment: 30 patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• congenital or acquired, cognitive or motor neurodisability;
• cooperation and abiity to understand the offered activities;
• where necessary, parents or legal guardians able to commit to and cooperate in a home-based telerehabilitation program.

Exclusion criteria

• Developmental disorders;
• Psychiatric disorders.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

VRRS group

Experimental group

Description:

Participants will receive telerehabilitation treatment based delivered by Khymeia VRRS technology platform. The VRRS device, in the home version, is used in tele-rehabilitation mode. There are two modes of operation in tele-rehabilitation: on line mode: the therapist is able to take control of the system remotely and interact with the patient in real time through the integrated two-way video conferencing system with pan and zoom camera with which the VRRS is equipped; off-line mode: the therapist can prepare a list of exercises to be performed by the patient at home, assisted by the "smart virtual assistant" who guides the patient in the execution of the rehabilitation program. The home device automatically records all activities performed by the patient independently. The therapist can connect to the home device at any time to review the tests performed or modify the exercise list or make appropriate changes to the specific patient's rehabilitation program.

Treatment:

Device: Khymeia VRRS