Investigation of the Usability of the Dynamic Scaffolding System

Completed

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

• Registration Number: NCT05727046
• Lead Sponsor: Karadeniz Technical University

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.

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01
• Study First Submitted: 2023-01-25
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Children with motor disabilities

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Uskudar University; 🇹🇷 Istanbul, Turkey

Karadeniz Technical University; 🇹🇷 Trabzon, Turkey