Clinical trial NCT05727046: Investigation of the Usability of the Dynamic Scaffolding System
Official title: Investigation of the Usability of the Dynamic Scaffolding System An Adaptive Mobility Device in Children With Special Needs and Parental Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Development Disorder
Child Development
Assistive Technology
Keywords: children with disability
assistive device
walker
children
Dynamic Scaffolding System
Parental satisfaction
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: Uskudar University
First posted: 2023-02-14
Enrollment: 100
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children with motor difficulties

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.

Eligibility criteria: Inclusion Criteria:

* Children with motor disabilities

Exclusion Criteria:

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

Primary outcomes:
measure: Everyday Usage Time of Dynamic Scaffolding System (DSS)
timeFrame: After 1 months experience of Dynamic Scaffolding System
Secondary outcomes:
measure: Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
timeFrame: After 1 months experience of Dynamic Scaffolding System
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University
city: Istanbul
country: Turkey
facility: Uskudar University
city: Trabzon
country: Turkey
facility: Karadeniz Technical University
Study officials:
References: