Investigation of the Usability of the Dynamic Scaffolding System

Sponsor
Karadeniz Technical University (Other)
Overall Status
Completed
CT.gov ID
NCT05727046
Collaborator
Uskudar University (Other)
100
3
11
33.3
3

Study Details

Study Description

Brief Summary

The aim of the present study was to compare the duration of use of the Dynamic Scaffolding System (DSS) in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. One hundred children with special needs aged between 9 and 108 months who had used the DSS device for at least 6 months and their parents were included in the study. The duration of daily use of the DSS device by the children, any adverse events during use, and parental satisfaction were assessed using the Quebec 2.0 Assistive Technology User Satisfaction Assessment Questionnaire.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Children with special needs with mobility difficulties use various assistive devices to benefit from the beneficial effects of standing upright and moving. These devices have beneficial effects on improving children's motor skills and increasing their social interaction and participation. In addition, during the use of assistive devices, there are some limitations related to size, weight, usability, mobility, and adaptability to children. Considering these limitations, the Dynamic Scaffolding System (DSS) device was developed. The DSS device aims to position children with moderate to severe mobility impairment vertically (standing and sitting) and to step with support. The aim of the current study was to compare the duration of use of the Dynamic Scaffolding System (DSS) device in children with different levels of motor impairment, to report adverse events during use, and to examine parental satisfaction. One hundred children with special needs (60% cerebral palsy, 40% other diagnoses: genetic, metabolic, neuromuscular diseases) aged between 9 and 108 months (mean 44.94±17.59) and their parents (94% mother, 6% father) who had used the DSS device for at least 6 months were included in the study. Data were collected from the participants via telephone interview. Demographic data such as age, gender, diagnosis, and level of motor impairment were recorded. Children's daily use of the DSS device, any adverse events during use, and parental satisfaction were assessed using the Quebec 2.0 Assistive Technology User Satisfaction Assessment Questionnaire.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Investigation of the Usability of the Dynamic Scaffolding System An Adaptive Mobility Device in Children With Special Needs and Parental Satisfaction
    Actual Study Start Date :
    Jan 1, 2022
    Actual Primary Completion Date :
    Jun 1, 2022
    Actual Study Completion Date :
    Dec 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Children with cerebral palsy and Children with other diagnoses

    Of the children with special needs included in the study, 60% were parents of children with cerebral palsy. 40% of the children with special needs included in the study had Hydrocephalus, Arthrogryposis, Multiplex Congenita, Down Syndrome, Microcephaly, Alpha-thalassemia mental retardation syndrome (ATRX), Spinal Muscular Atrophy (SMA) Type 1, Spinal Muscular Atrophy (SMA) Type 2, L2 hydroxy glutaric aciduria, Prader Willi syndrome, Periventricular leukomalacia grade 1, Hypotonia, Angelman syndrome, Genetic chromosomal abnormality, Dandy-walker syndrome, Western syndrome, Infantile epileptic encephalopathy, Stroke-like migraine attacks after radiation therapy (SMART syndrome), Trigonocephaly, Motor developmental delay, Lissencephaly, Spina bifida, Leigh syndrome and Epilepsy.

    Outcome Measures

    Primary Outcome Measures

    1. Everyday Usage Time of Dynamic Scaffolding System (DSS) [After 1 months experience of Dynamic Scaffolding System]

      Dynamic Scaffolding System is an assistive device for children with special needs. We measure the usage time of DSS by the chronometer.

    Secondary Outcome Measures

    1. Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) [After 1 months experience of Dynamic Scaffolding System]

      The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0) is a 12-item outcome measure that assesses user satisfaction with two components such as Devices and Services. Psychometric properties have been tested with respect to test-retest stability. The participants give answers on a 5-point Likert Scale. The high point means better results.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    9 Months to 18 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Children with motor disabilities
    Exclusion Criteria:
    • If children did not use Dynamic Scaffolding System for less than one month

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uskudar University Istanbul Turkey 315662
    2 Uskudar University Istanbul Turkey
    3 Karadeniz Technical University Trabzon Turkey 5065938882

    Sponsors and Collaborators

    • Karadeniz Technical University
    • Uskudar University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turgay Altunalan, Principal Investigator, Karadeniz Technical University
    ClinicalTrials.gov Identifier:
    NCT05727046
    Other Study ID Numbers:
    • KaradenizTechnicalU
    • Beyzanur Dikmen
    • Melek Vatansever
    First Posted:
    Feb 14, 2023
    Last Update Posted:
    Feb 14, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Turgay Altunalan, Principal Investigator, Karadeniz Technical University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 14, 2023