Tele-rehabilitation in Subjects With Congenital and Acquired Developmental Disabilities

NCT06219447 | Unknown

• 1 other identifier: TABLET-TOSCANA
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Information and Communication Technologies; Tele-rehabilitation; Neuropsychomotor skills; Language skills; Neurodevelopmental disabilities; Organizational models; Feasibility

Outcome Measures

Primary Outcomes (6)

• Tele-rehabilitation feasibility measures: Study adherence

  Rate of acceptance of the participation in the study calculated as the number of eligible participants that agree to join the project.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

• Tele-rehabilitation feasibility measures: Adherence to training

  Total number of training sessions completed on the total number of sessions scheduled by the clinicians, expressed as a ratio.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

• Tele-rehabilitation feasibility measures: Number of dropouts

  Number of participants that will not complete the all study procedures.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

• Tele-rehabilitation feasibility measures: Number of sessions completed in the target time

  Total number of training session completed in the timeframe setted by clinicians.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

• Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running

  Number of issues and malfunctioning experimented by clinicians and families during the training sessions.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

• Feasibility questionnaire

  In order to investigate the feasibility of the system used and the compliance of children, their families and the clinicians, will be carried out an ad hoc questionnaire at the end of the training, during the post-intevention assessment. The answer questionnaire is built with a 5-point likert scale; higher scores means a greater feasibility for the stakeholder who filled the questionnaire.

  T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)

Secondary Outcomes (30)

• Changes in Sustained attention subtest of Leiter 3

  T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)

• Changes in visual attention CP subtest of Italian Battery for ADHD (BIA)

  T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)

• Changes in Conners' Parent Rating Scale - Brief version

  T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)

• Changes in Visuo-motor precision subtest of NEPSY II

  T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)

• Changes in Developmental Test Of Visuo-Motor Integration

  T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)

Study Arms (2)

Experimental group

EXPERIMENTAL

Children will be immediately trained through the TABLET TOSCANA technologies (VRRS Home Tablet or Medico Amico Kids APP) for a cycle of 3 months.

Device: VRRS Home Tablet or Medico Amico Kids APP

Waitlist group

NO INTERVENTION

Children will continue standard care for 3 months and after that they will be guaranteed to be enrolled for the next 3-month cycle through the TABLET TOSCANA technologies (VRRS Home Tablet or Medico Amico Kids APP).

Interventions

VRRS Home Tablet or Medico Amico Kids APP DEVICE

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.

Experimental group

Eligibility Criteria

• Age: 6 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Congenital or acquired developmental disabilities;
• Ages from 6 to 30 years old at the time of recruitment;
• Cognitive functioning that allows sufficient understanding of proposed activities and cooperation in exercises, investigated by appropriate rating scales (WPPSI-III or WPPSI-IV or WISC-IV or WAIS-IV or LEITER-R or LEITER-3 or RAVEN Matrices).
• Sufficient distance from the clinical center to allow periodic in-person assessment of progress
• Possibility to have internet access at home
• Caregivers able to be committed to and cooperate in an intensive rehabilitation home-based program.
• Manual Ability Classification System (MACS) level \< V

You may not qualify if:

• Severe comorbidities and/or severe cognitive disability
• MACS level V

Sponsors & Collaborators

• Giovanni Cioni: lead
• Azienda USL Toscana Nord Ovest: collaborator
• Scuola Superiore Sant'Anna di Pisa: collaborator

Study Sites (1)

IRCCS Fondazione Stella Maris

Pisa, PI, 56128, Italy

RECRUITING

Central Study Contacts

Giuseppina Sgandurra, MD, PhD

CONTACT

050 886233/224; g.sgandurra@fsm.unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD

Model Details: It will be a waitlist study

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 23, 2024
• Study Start: February 12, 2021
• Primary Completion: February 12, 2024
• Study Completion: June 12, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)