Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project)

NCT ID: NCT06290297

Last Updated: 2024-03-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-30
• Study Completion Date: 2024-06-30

Brief Summary

The development and application of new technologies to support functional assessment and rehabilitation pathways for neurodevelopmental disabilities allow the evaluation and enhancement of cognitive, motor, and speech abilities within a more playful and motivating context. In fact telerehabilitation programs foster access to rehabilitative services and permit the delivery of a wide range of neuropsychological, motor, speech and communication interventions, even for patients unable to frequently attend a clinical institution (distance from the hospital, parental work employment, etc.), by overcoming geographic barriers. In this scenario, new technologies guarantee significant time- and cost-saving, shortening hospitalization and delivering the rehabilitative process at home, in a more ecological context (American Telemedicine Association, 2017) therefore enforcing the generalization of the achieved competences. Another great advantage provided by using innovative technologies in clinical practice to foster therapies tailored to patient's needs concerns both the possibility of collecting comprehensive and accurate quantitative data, thus supporting a better intervention monitoring, and of offering multi domain activities, also integrating peripheral devices (i.e. sensors). Using innovative technologies in clinical practice also give the possibility to propose neuropsychological and motor activities in a playful and motivating context, thus enhancing participation and enjoyment, especially for the pediatric population, while maintaining high levels of efficiency. Such telerehabilitation pathways allow to increase dosage and intensity of the intervention and ensure caregivers' involvement in the rehabilitation process. This multicenter study aims to assess the feasibility of using technological systems, primarily validated in the adult population, in children with congenital and acquired disabilities by administering ad-hoc questionnaires.

Detailed Description

The study aims assessing the feasibility of using technological systems, in a pediatric population with congenital and acquired neurodevelopmental disabilities, for the assessment and rehabilitation of cognitive, motor and speech functions. A group of children aged between 4 and 18 years with neurodevelopmental disabilities of heterogeneous etiopathogenesis is selected. A non-randomized allocation is planned based on the specific children needs, according to their age and functional profile.

Specifically, the study has envisaged several detailed phases. At first, an analysis of the exercises within the library of the technological systems used by participating IRCCS (VRRS - Khymeia, Niurion) is conducted. After a careful evaluation, the selected exercises (based on age and functional profile) are categorized using a rating methodology and expert discussions, in order to identify specific protocols according to the involved cognitive, speech, and/or motor function. Options for the different exercises are discussed and organized to order them hierarchically and plan a progression of activity proposals based on required skill levels. Some implementation of the present exercises are proposed, in order to make the system more suitable for developmental age, thanks to the collaboration between the clinical staff and the producers.

The created protocols are administered as one-shot assessment in a single session to a group of 4-18 years old children with neurodevelopmental disabilities. Usability and acceptability questionnaires, specifically created for this purpose, are administered, to assess the feasibility of using such technological systems, validated for adults, in the pediatric population. According to the functional profile and one-shot session the possibility of undergoing a tele-rehabilitation program is also considered for each child, with variable duration and frequency based on specific children and caregivers emerging needs. Specific inclusion and exclusion criteria are defined:

Inclusion Age between 4-18 years old Non-degenerative, congenital or acquired neurodevelopmental disability A cognitive functioning sufficient for understanding instructions and participating in delivered activities MACS <5 Exclusion Severe associated pathologies Criteria for the accessibility to tele-rehabilitation programs are also established, including a distance from the clinical center to allow periodic in-person evaluation of the training progress, internet access availability, and the willingness of parents and/or legal guardians to engage in and collaborate with an intensive home-based rehabilitation program.

Participants included in a tele-rehabilitation intervention (cognitive, motor, speech, or integrated) are provided with ICT technologies, delivered directly to their homes, including peripheral devices and a user manual for caregivers. Rehabilitation sessions at home are constantly monitored remotely by the rehabilitation staff, either online or through the offline viewing of obtained reports. Intervention has a global duration of 30 sessions at least, with a variable frequency based on specific children and caregivers emerging needs.

Finally, indicators for measuring the feasibility and effectiveness of different tele-rehabilitation programs are selected based on the literature, as well as clinical assessment scales for cognitive, speech and motor skills. Questionnaires for each end-user category have been developed to analyze different aspects of usability and acceptability, including perceived satisfaction, effectiveness, and efficiency on one hand, and experienced ease of use and utility on the other. From a clinical perspective, a shared protocol of pre-post training clinical measures has been developed to evaluate not only specific cognitive, speech and motor aspects but also any impact on participation and quality of life. This protocol is administered to each child at the end of the tele-rehabilitation program.

Conditions

Neurodevelopmental Cognitive, Motor and Speech-language Disabilities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Children with neurodevelopmental disabilities

Children aged 4 to 18 with cognitive, motor and/or speech-language impairments

Group Type: EXPERIMENTAL

Telerehabilitation VRRS

Intervention Type: DEVICE

Telerehabilitation programs delivered at home, aiming to improve cognitive, motor and/or speech-language skills, through VRRS - Khymeia or Niurion devices. Such technologies are equipped with a wide library of activities to be performed also with the use of peripheral sensors. A one-shot assessment is also proposed to children admitted to institutes adhering to the project in order to understand the feasibility of the use of such devices. Ad hoc feasibility questionnaire are administered at the end of the one shot session and after the home training to the main stakeholders (children, families, clinicians)

Interventions

Telerehabilitation VRRS

Telerehabilitation programs delivered at home, aiming to improve cognitive, motor and/or speech-language skills, through VRRS - Khymeia or Niurion devices. Such technologies are equipped with a wide library of activities to be performed also with the use of peripheral sensors. A one-shot assessment is also proposed to children admitted to institutes adhering to the project in order to understand the feasibility of the use of such devices. Ad hoc feasibility questionnaire are administered at the end of the one shot session and after the home training to the main stakeholders (children, families, clinicians)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Children with congenital or acquired brain injuries and/or neurodevelopmental disabilities
• Aged from 4-18 years old
• MACS < 5
• Cognitive functioning allowing an adequate understanding of the 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).
• Distance from the clinical center in order to permit periodic in-person assessments
• Internet access
• Parents or legal guardians able to commit to and cooperate in an intensive home-based rehabilitation program.

Exclusion Criteria

• Severe comorbidities and/or severe cognitive disability

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Don Carlo Gnocchi Onlus

OTHER

Sponsor Role: collaborator

IRCCS Eugenio Medea

OTHER

Sponsor Role: collaborator

Oasi Research Institute-IRCCS

OTHER

Sponsor Role: collaborator

Ospedale Pediatrico Bambin Gesù

OTHER

Sponsor Role: collaborator

IRCCS San Raffaele Roma

OTHER

Sponsor Role: collaborator

IRCCS National Neurological Institute "C. Mondino" Foundation

OTHER

Sponsor Role: collaborator

IRCCS Centro Neurolesi Bonino Pulejo

OTHER

Sponsor Role: collaborator

Istituto Giannina Gaslini

OTHER

Sponsor Role: collaborator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: collaborator

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

OTHER

Sponsor Role: collaborator

IRCCS Ospedale San Raffaele

OTHER

Sponsor Role: collaborator

IRCCS Istituto delle Scienze Neurologiche di Bologna

OTHER

Sponsor Role: collaborator

IRCCS Fondazione Stella Maris

OTHER

Sponsor Role: lead

Responsible Party

Giuseppina Sgandurra

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Fondazione Stella Maris

Pisa, PI, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giuseppina Sgandurra, PhD, MD

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

Progetti di Rete (RIN-IDEA)

Identifier Type: -

Identifier Source: org_study_id