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

NCT06290297 | Recruiting

• 1 other identifier: Progetti di Rete (RIN-IDEA)
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurodevelopmental Cognitive, Motor and Speech-language Disabilities

Keywords

Neurodevelopmental disabilities; cognitive functions; motor skills; telerehabilitation; technologies; speech functions; ICTs; innovation; congenital and acquired disabilities

Outcome Measures

Primary Outcomes (7)

• Scores of One shot feasibility questionnaire (5-point likert scale)

  An ad hoc feasibility questionnaire has been developed, according to the scientific literature, in order to investigate the acceptability and usability of the motor, cognitive, speech-communication assessment with the use of new technologies taken into account in the study. The questionnaire has been administered to the main stakeholders (clinicians, children) at the end of the one shot session assessment, delivering cognitive, motor or speech-communication activities, in order to investigate the usability and acceptability of the system with the child. Higher scores means a greater feasibility for the stakeholder who filled the questionnaire. Score ranges in the clinican form 16 to 80, while for the children form 18-90.

  [Time frame: T0 (after the first assessment session with technological system (one shot))]

• Tele-rehabilitation feasibility measures: Adherence to the study

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

  [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]

• Tele-rehabilitation feasibility measures: Adherence to the training

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

  [Time Frame: 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.

  [Time Frame: 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.

  [Time Frame: 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.

  [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]

• Scores of training feasibility questionnaire (5-point likert scale)

  An ad hoc feasibility questionnaire has been developed, according to the scientific literature, in order to investigate the acceptability and usability of the tele-rehabilitation training delivered through the technologies used in the study. The questionnaire has been administered to the main stakeholders (clinicians, caregivers, children) at the end of the training, in order to investigate required effort, adaptability of the training at home, exercises customization, system suidabiliy. Higher scores means a greater feasibility for the stakeholder who filled the questionnaire. Score ranges in the clinican form 20 to 100, while for the children and caregivers forms 24-120.

  [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]

Secondary Outcomes (21)

• Changes in the Sustained attention subtest of Leiter 3

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

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

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

• Changes in the Conners' Parent Rating Scale - Brief version

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

• Changes in the Visuo-motor precision subtest of NEPSY II

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

• Changes in the Developmental Test Of Visuo-Motor Integration (VMI)

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

Study Arms (1)

Children with neurodevelopmental disabilities

EXPERIMENTAL

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

Device: Telerehabilitation VRRS

Interventions

Telerehabilitation VRRS 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)

Children with neurodevelopmental disabilities

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Severe comorbidities and/or severe cognitive disability

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• IRCCS Eugenio Medea: collaborator
• Oasi Research Institute-IRCCS: collaborator
• Ospedale Pediatrico Bambin Gesù: collaborator
• IRCCS San Raffaele Roma: collaborator
• IRCCS National Neurological Institute "C. Mondino" Foundation: collaborator
• IRCCS Centro Neurolesi Bonino Pulejo: collaborator
• Istituto Giannina Gaslini: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta: collaborator
• IRCCS Ospedale San Raffaele: collaborator
• IRCCS Istituto delle Scienze Neurologiche di Bologna: collaborator

Study Sites (1)

IRCCS Fondazione Stella Maris

Pisa, PI, 56128, Italy

RECRUITING

Central Study Contacts

Giuseppina Sgandurra, PhD, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 16, 2024
• First Posted: March 4, 2024
• Study Start: September 30, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)