Investigation of the Usability of the Dynamic Scaffolding System

NCT05727046 | Completed

• 3 other identifiers: KaradenizTechnicalUBeyzanur DikmenMelek Vatansever
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Child Development Disorder; Child Development; Assistive Technology

Keywords

children with disability; assistive device; walker; children; Dynamic Scaffolding System; Parental satisfaction

Outcome Measures

Primary Outcomes (1)

• Everyday Usage Time of Dynamic Scaffolding System (DSS)

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

  After 1 months experience of Dynamic Scaffolding System

Secondary Outcomes (1)

• Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)

  After 1 months experience of Dynamic Scaffolding System

Study Arms (1)

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.

Eligibility Criteria

• Age: 9 Months - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Children with motor difficulties

You may qualify if:

• Children with motor disabilities

You may not qualify if:

• If children did not use Dynamic Scaffolding System for less than one month

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Uskudar University: collaborator

Study Sites (3)

Uskudar University

Istanbul, 315662, Turkey (Türkiye)

Location

Uskudar University

Istanbul, Turkey (Türkiye)

Location

Karadeniz Technical University

Trabzon, 5065938882, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 14, 2023
• Study Start: January 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 14, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (3)