Clinical trial NCT06290297: Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities (Tablet Project)
Official title: Assessment and Telerehabilitation of Cognitive and Motor Skills in Children With Neurodevelopmental Disabilities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: IRCCS Fondazione Stella Maris
Sponsor class: OTHER
Collaborators: name: Fondazione Don Carlo Gnocchi Onlus
name: IRCCS Eugenio Medea
name: Oasi Research Institute-IRCCS
name: Ospedale Pediatrico Bambin Gesù
name: IRCCS San Raffaele Roma
name: IRCCS National Neurological Institute "C. Mondino" Foundation
name: IRCCS Centro Neurolesi Bonino Pulejo
name: Istituto Giannina Gaslini
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
name: IRCCS Ospedale San Raffaele
name: IRCCS Istituto delle Scienze Neurologiche di Bologna
First posted: 2024-03-04
Enrollment: 350
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Scores of One shot feasibility questionnaire (5-point likert scale)
timeFrame: [Time frame: T0 (after the first assessment session with technological system (one shot))]
measure: Tele-rehabilitation feasibility measures: Adherence to the study
timeFrame: [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]
measure: Tele-rehabilitation feasibility measures: Adherence to the training
timeFrame: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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: [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]
measure: Scores of training feasibility questionnaire (5-point likert scale)
timeFrame: [Time Frame: T1 (at the end of the tele-rehabilitation, i.e. 3 months after the start of treatment)]
Secondary outcomes:
measure: Changes in the Sustained attention subtest of Leiter 3
timeFrame: [Time Frame: 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 visual attention subtest (CP) of Italian battery for ADHD (BIA)
timeFrame: [Time Frame: 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 Conners' Parent Rating Scale - Brief version
timeFrame: [Time Frame: 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 Visuo-motor precision subtest of NEPSY II
timeFrame: [Time Frame: 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 Developmental Test Of Visuo-Motor Integration (VMI)
timeFrame: [Time Frame: 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 digit span forwards and backward subtests of BVN both for children aged 5-11 and for children aged 12-18
timeFrame: [Time Frame: 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 Corsi Block Tapping test subtest of BVS-Corsi
timeFrame: [Time Frame: 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 Behaviour Rating inventory of executive function (BRIEF 2/P ) for parents
timeFrame: [Time Frame: 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 route finding subtest of NEPSY II
timeFrame: [Time Frame: 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 arrow subtest of NEPSY II
timeFrame: [Time Frame: 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 Gross Motor Function Measure 88 (GMFM-88)
timeFrame: [Time Frame: 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: [Time Frame: 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: [Time Frame: 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 Melbourne Assessment of Unilateral Upper Limb Function o Melbourne Assessment 2 (MUUL o MA2)
timeFrame: [Time Frame: 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 Abilhand Kids
timeFrame: [Time Frame: 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 Box and Block test (BBT)
timeFrame: [Time Frame: 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 Movement Disorders - Childhood Rating Scale 4-18 revised (MD-CRS 4-18 R)
timeFrame: [Time Frame: 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 6 minutes walk test (6MWT)
timeFrame: [Time Frame: 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 Functional Reach Test (FRT)
timeFrame: [Time Frame: 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 Pediatric Berg Balance Scale (PBS)
timeFrame: [Time Frame: 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 Timed up and go (TUG)
timeFrame: [Time Frame: 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: