IMPLEMENTATION OF A PILOT TELEREHABILITATION NETWORK IN PEDIATRIC PATIENTS WITH COMPLEX NEURODSABILITIES MedeaNeuroTelerehab-Net (MENTE.NET STUDY)

Neurological Diseases or Conditions Clinical Trial

Official title: IMPLEMENTATION OF A PILOT TELEREHABILITATION NETWORK IN PEDIATRIC PATIENTS WITH COMPLEX NEURODSABILITIES MedeaNeuroTelerehab-Net (MENTE.NET STUDY)

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Nervous System Diseases
• Neurological Diseases or Conditions

• NCT number: NCT06450717
• Study type: Interventional
• Source: IRCCS Eugenio Medea
• Contact: Antonio Trabacca, MD
• Phone: 0831349111
• Email: antonio.trabacca@lanostrafamiglia.it
• Status: Recruiting
• Phase: N/A
• Start date: December 28, 2022
• Completion date: June 9, 2024