Clinical trial NCT06219447: Tele-rehabilitation in Subjects With Congenital and Acquired Developmental Disabilities
Official title: Innovative Models for Taking on and Tele-rehabilitation of Neuropsychomotor and Language Skills in Children and Adolescents With Congenital and Acquired Developmental Disabilities (TABLET-TOSCANA).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Congenital and Acquired Developmental Disabilities
Keywords: Information and Communication Technologies
Tele-rehabilitation
Neuropsychomotor skills
Language skills
Neurodevelopmental disabilities
Organizational models
Feasibility
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Azienda USL Toscana Nord Ovest
name: Scuola Superiore Sant'Anna di Pisa
First posted: 2024-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It will be a waitlist study
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Tele-rehabilitation feasibility measures: Study adherence
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
measure: Tele-rehabilitation feasibility measures: Adherence to training
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
measure: Tele-rehabilitation feasibility measures: Number of dropouts
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
measure: Tele-rehabilitation feasibility measures: Number of sessions completed in the target time
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
measure: Tele-rehabilitation feasibility measures: Technical problems encountered that prevent the program from running
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
measure: Feasibility questionnaire
timeFrame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)
Secondary outcomes:
measure: Changes in Sustained attention subtest of Leiter 3
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in visual attention CP subtest of Italian Battery for ADHD (BIA)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Conners' Parent Rating Scale - Brief version
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Visuo-motor precision subtest of NEPSY II
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Developmental Test Of Visuo-Motor Integration
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in digit span forwards and backward subtests of BVN
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Corsi Block Tapping test subtest of BVS-Corsi
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Behaviour Rating inventory of executive function (BRIEF 2/P) for parents
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in route finding subtest of NEPSY II
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in arrow subtest of NEPSY II
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in reading and writing tasks of Dyslexia and Developmental Dysortography Evaluation-2 (DDE-2)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in reading and writing tasks of Martini Battery
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in writing tasks of Battery for the assessment of writing and orthographic competence-2 (BVSCO-2)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in reading and text comprehension of MT Battery- Third Version (MT-3)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in lexical comprehension of Peabody Picture Vocabulary Test - Revised (PPVT-R)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Children's Grammatical Comprehension Test (TCGB)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Gross Motor Function Measure 88 (GMFM-88)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in 6 minutes walking test (6MWT)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Pediatric Balance Scale (PBS)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Functional Reach Test (FRT)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Timed Up and Go (TUG)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in the Assisting Hand Assessment (AHA)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Both Hand Assessment (BoHA)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Melbourne Assessment 2 (MA2)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Box and Block Test (BBT)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Movement Disorders - Childhood Rating Scale Revised (MD-CRS R)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Test of Visual Perception and Visuo-motor Integration (TPV)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Abilhand Kids
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Movement Assessment Battery for Children- Second Edition (MABC-2)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
measure: Changes in Praxic and Motor Coordination Skills-2nd Edition (APCM-2)
timeFrame: T0 (before beginning of the treatment); T1 (at the end of the treatment, i.e. 3 months after the start of treatment)
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: IRCCS Fondazione Stella Maris
state: PI
Study officials:
References: