Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05727046 |
| Other study ID # |
KaradenizTechnicalU |
| Secondary ID |
Beyzanur DikmenM |
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
December 1, 2022 |
Study information
| Verified date |
February 2023 |
| Source |
Karadeniz Technical University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
