Tele-rehabilitation in Subjects With Congenital and Acquired Developmental Disabilities

NCT ID: NCT06219447

Last Updated: 2024-01-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-12
• Study Completion Date: 2024-06-12

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.

Detailed Description

Tele-rehabilitation is designed as a timely, intensive, and personalized intervention aimed to provide access to rehabilitation services monitoring by the clinical staff. This intervention enables activities to be carried out in an ecological and home-based environment, following the key components of evidence-based neuropsychological and motor rehabilitation. Different studies, including those conducted in Italy, have demonstrated promising results through the application of Information and Communication Technologies (ICTs) in rehabilitation, even in the developmental age. Tele-rehabilitation, therefore, could be particularly suitable to support the treatment of children with neurodevelopmental disorders and their families, in order to enable continuity of care by extending rehabilitation programs into home settings, fostering family involvement, continuous monitoring by the clinical team. This was even more relevant during the critical period of the COVID-19 emergency, as the use of ICT proved indispensable for the uninterrupted care of patients and their families and, consequently, mitigate the adverse consequences of care disruptions on the short-, medium-, and long-term neuropsychological outcomes, stress levels, and overall quality of life for the entire family.

The overarching aim of the TABLET-TOSCANA project is to develop innovative organizational models that foster the continuity of care and tele-rehabilitation for neuro-psychomotor and language functions in children with congenital and acquired developmental disabilities. Throughout the project, two technologies currently employed in the cognitive, motor, and speech rehabilitation of adult patients will be adapted for the pediatric population: (i) the VRRS Home Tablet and (ii) the Medico Amico Kids APP. Later, these technologies will be tested in the pediatric and young adult populations through a waitlist-type randomized pilot study evaluating usability, acceptability and economic sustainability by the principal stakeholders (patients, their caregivers and all members of the multidisciplinary clinical team, such as child neuropsychiatrists, physiatrists, neuropsychologists, developmental neuropsychomotricity therapists, physical therapists, speech therapists). This project unfolds into three main phases.

(i) The initial phase involves the implementation of the Medico Amico Kids APP and the VRRS Home Tablet in order to adapt them to the pediatric population's specific needs. Specifically, both technologies will facilitate professionals in monitoring, conducting teleconsultations, and delivering treatment programs through online or offline tele-rehabilitation sessions. The clinical team, in relation to their expertise, will meticulously analyze the library of motor, cognitive and language exercises currently available in both systems in order to implement it in collaboration with Khymeia bioengineers to enhance usability for the pediatric population.

(ii) The middle phase will focus on technology validation: 100 subjects (80 children and 20 young adults) will be recruited in a pilot study. It will be a waitlist study to ensure that all enrolled patients will be eligible for the experimental treatment. Subjects will be selected and stratified according to diagnosis (congenital or acquired developmental disorder group), functional gross-motor level (GMFCS I-II/GMFCS III-IV), age (6-10/11-15/16-20/21-30), type of organizational model, and technology (APP vs. Home Tablet). After the evaluation, participants will be randomly assigned to either the experimental group (EG) (providing a 3-month tele-rehabilitation) or the waitlist group (WG) (continuing traditional rehabilitation care for the same duration). All children will be evaluated before and after 3 months of intervention with standardized clinical tests. At the end of tele-rehabilitation of EG, ad-hoc questionnaires, aligned with standardized tools and investigation criteria from a literature review, will be administered to assess feasibility and sustainability across various areas, including usability and acceptability, defined by ISO/DIS 9241-11 standard and the Technology Acceptance Model, respectively.

(iii) During the final phase both feasibility and the preliminary efficacy data will be processed. In particular, feasibility data will comprise not only the ad-hoc designed questionnaire but also parameters such as: study and rehabilitation adherence, number of drop out, number of sessions completed within the period of treatment defined, encountered technical problems hindering tele-rehabilitation execution, and acceptance evaluations. Regarding the efficacy data, given the heterogeneity of the clinical population in terms of both chronological age and functional profile, a wide set of tests with normative data covering an extended age range has been selected for the assessment of cognitive, neuropsychological, motor, and language abilities. This approach will allow for the selection of the tests most suited to each patient's functional profile. Furthermore, treatment effectiveness will be examined using the Goal Attainment Scale (GAS), a rehabilitation outcome measure, which is scored based on individual goals hypothesized and achieved throughout the intervention. Finally, the merging of these datasets will contribute to the formulation of innovative organizational models, incorporating tele-assistance and tele-rehabilitation pathways.

Conditions

Congenital and Acquired Developmental Disabilities

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

VRRS Home Tablet or Medico Amico Kids APP

Intervention Type: 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.

Waitlist group

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role: collaborator

Scuola Superiore Sant'Anna di Pisa

OTHER

Sponsor Role: collaborator

Giovanni Cioni

OTHER

Sponsor Role: lead

Responsible Party

Giovanni Cioni

MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

IRCCS Fondazione Stella Maris

Pisa, PI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppina Sgandurra, MD, PhD

Role: CONTACT

g.sgandurra@fsm.unipi.it

050 886233/224 ext. +39

Facility Contacts

Giuseppina Sgandurra, MD, PhD

Role: primary

g.sgandurra@fsm.unipi.it

050 886233/224 ext. +39

Other Identifiers

TABLET-TOSCANA

Identifier Type: -

Identifier Source: org_study_id