Tele-rehabilitation in Subjects With Congenital and Acquired Developmental Disabilities

NCT06219447 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-01-23

No results posted yet for this study

Summary

The COVID-19 emergency has led to the complete closure of all rehabilitation services, both public and/or private, across Italy, including the region of Tuscany. Among the various consequences of the COVID-19 pandemic, a significant negative indirect impact on children with neurodevelopmental disabilities and their families was observed. Specifically within Tuscany, a substantial decline occurred in rehabilitative interventions, including physiotherapy, language therapy, and neuropsychological therapy. Despite these challenges, some healthcare facilities responded by initiating tele-rehabilitation treatments, even if on a limited scale, following the recommendations of scientific societies within the field. In this framework, TABLET-TOSCANA project has been developed, with the overall aim of developing innovative organizational models to ensure the continuity of care for treatment and tele-rehabilitation of neuro-psychomotor and language functions in children with congenital and acquired developmental disabilities. The present proposal aims to evaluate the feasibility of this approach and the economic sustainability of employing the implemented technologies to promote tele-rehabilitation as possible territorial care taking. Additionally, the study aims to conduct a preliminary efficacy evaluation by analyzing pre-post treatment changes identified in outcome measures, providing valuable insights into the potential benefits of this tele-rehabilitation proposal.

Conditions

  • Congenital and Acquired Developmental Disabilities

Interventions

DEVICE

VRRS Home Tablet or Medico Amico Kids APP

Tele-rehabilitation (TR) permits intensive and personalized intervention monitored by clinicians in an ecological friendly, home setting. The VRRS Home Kit, comprising a tablet and peripheral devices, permits TR of cognitive, speech and motor functions. These peripherals such as sensors and balances allow motor rehabilitation across different body districts involved (upper and lower limbs, trunk). Touch screen activities, enables neuropsychological and speech therapy sessions. Medico Amico APP, offers a wide library of cognitive, language and motor exercises, stratified by difficulty levels, targeting specific functions. An avatar guides real-time movements, offering visual references. Adjustable parameters include duration, repetitions, difficulty, speed, movement amplitude. Both technologies facilitate TR sessions via a dedicated platform, that can occur in real-time, involving interaction with patients, or independently with continuous monitoring by clinical staff.

Sponsors & Collaborators

  • Azienda USL Toscana Nord Ovest

    collaborator OTHER
  • Scuola Superiore Sant'Anna di Pisa

    collaborator OTHER
  • Giovanni Cioni

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2024-02-12
Completion
2024-06-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06219447 on ClinicalTrials.gov