Clinical trial NCT06450717: Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net (MENTE.NET Study)
Official title: Implementation of a Pilot Telerehabilitation Network in Pediatric Patients With Complex Neurodisabilities MedeaNeuroTelerehab-Net (MENTE.NET Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Diseases or Conditions
Keywords: Neurological condition
Telerehabilitation
Lead sponsor: IRCCS Eugenio Medea
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is a two-year multicenter prospective clinical-experimental 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. At least 10 patients (age 4-18) per pole are expected to be enrolled in this pilot phase.
Primary purpose: DEVICE_FEASIBILITY

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: True or False? (VRRS Task - executive functioning)
timeFrame: baseline (immediately pre-training)
measure: True or False? (VRRS Task - executive functioning)
timeFrame: post-training (approximatively at week 4)
measure: Bells Test
timeFrame: baseline (immediately pre-training)
measure: Bells Test
timeFrame: post-training (approximatively at week 4)
measure: Visual attention (NEPSY II task)
timeFrame: baseline (immediately pre-training)
measure: Visual attention (NEPSY II task)
timeFrame: post-training (approximatively at week 4)
measure: Attention and concentration software (exercise 3)
timeFrame: baseline (immediately pre-training)
measure: Attention and concentration software (exercise 3)
timeFrame: post-training (approximatively at week 4)
measure: Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: baseline (immediately pre-training)
measure: Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: post-training (approximatively at week 3)
measure: Melbourne Assessment of Unilateral Upper Limb Function
timeFrame: follow up (approximatively 1 month post-training)
measure: Scala Besta
timeFrame: baseline (immediately pre-training)
measure: Scala Besta
timeFrame: post-training (approximatively at week 3)
measure: Scala Besta
timeFrame: follow up (approximatively 1 month post-training)
measure: Movement Assessment Battery for Children (M-ABC)-II
timeFrame: baseline (immediately pre-training)
measure: Movement Assessment Battery for Children (M-ABC)-II
timeFrame: post-training (approximatively at week 3)
measure: Movement Assessment Battery for Children (M-ABC)-II
timeFrame: follow up (approximatively 1 month post-training)
measure: System Usability Scale (SUS) for PCI
timeFrame: baseline (immediately pre-training)
measure: System Usability Scale (SUS) for SMA
timeFrame: post-training (approximatively at week 3)
measure: Revised Hammersmith Scale (RHS)
timeFrame: baseline (immediately pre-training)
measure: Revised Hammersmith Scale (RHS)
timeFrame: post-training (approximatively at week 3)
measure: Revised Upper Limb Module (RULM) Scale
timeFrame: baseline (immediately pre-training)
measure: Revised Upper Limb Module (RULM) Scale
timeFrame: post-training (approximatively at week 3)
Secondary outcomes:
measure: Pediatric Quality of Life Inventor (PedsQLTM) for PCI
timeFrame: baseline (immediately pre-training)
measure: Pediatric Quality of Life Inventor (PedsQLTM) for PCI
timeFrame: post-training (approximatively at week 3)
measure: Pediatric Quality of Life Inventor (PedsQLTM) for PCI
timeFrame: follow up (approximatively 1 month post-training)
measure: Pediatric Quality of Life Inventor (PedsQLTM) for SMA
timeFrame: baseline (immediately pre-training)
measure: Pediatric Quality of Life Inventor (PedsQLTM) for SMA
timeFrame: post-training (approximatively at week 3)
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: Alessandra Bardoni
state: Lecco
city: Conegliano
country: Italy
facility: Andrea Martinuzzi
state: Treviso
city: Brindisi
country: Italy
facility: Antonio Trabacca
Study officials:
References: