Investigation of the Usability of the Dynamic Scaffolding System

Investigation of the Usability of the Dynamic Scaffolding System An Adaptive Mobility Device in Children With Special Needs and Parental Satisfaction

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.

Study Overview

• Status: Completed
• Conditions: Child Development; Assistive Technology; Child Development Disorder

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 315662
    • Üsküdar University
  • Istanbul, Turkey
    • Üsküdar University
  • Trabzon, Turkey, 5065938882
    • Karadeniz Technical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 months to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Children with motor difficulties

Description

Inclusion Criteria:

• Children with motor disabilities

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)	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.	After 1 months experience of Dynamic Scaffolding System

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Collaborators: Uskudar University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2022
• Primary Completion (ACTUAL): June 1, 2022
• Study Completion (ACTUAL): December 1, 2022

Study Registration Dates

• First Submitted: January 25, 2023
• First Submitted That Met QC Criteria: February 3, 2023
• First Posted (ESTIMATE): February 14, 2023

Study Record Updates

• Last Update Posted (ESTIMATE): February 14, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: children; Parental satisfaction; assistive device; children with disability; walker; Dynamic Scaffolding System
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Developmental Disabilities
• Other Study ID Numbers: KaradenizTechnicalU; Beyzanur Dikmen (OTHER: Uskudar University); Melek Vatansever (OTHER: Uskudar University)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No