Clinical Trials Directory

Trials / Completed

CompletedNCT05727046

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Karadeniz Technical University · Academic / Other
Sex
All
Age
9 Months – 18 Years
Healthy volunteers

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.

Conditions

Timeline

Start date
2022-01-01
Primary completion
2022-06-01
Completion
2022-12-01
First posted
2023-02-14
Last updated
2023-02-14

Locations

3 sites across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT05727046. Inclusion in this directory is not an endorsement.