Clinical Trials Logo

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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 1, 2022
Est. primary completion date June 1, 2022
Accepts healthy volunteers
Gender All
Age group 9 Months to 18 Years
Eligibility Inclusion Criteria: - Children with motor disabilities Exclusion Criteria: - If children did not use Dynamic Scaffolding System for less than one month

Study Design


Locations

Country Name City State
Turkey Uskudar University Istanbul
Turkey Uskudar University Istanbul
Turkey Karadeniz Technical University Trabzon

Sponsors (2)

Lead Sponsor Collaborator
Karadeniz Technical University Uskudar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
See also
  Status Clinical Trial Phase
Completed NCT06315036 - Effects of Developmental Gymnastics on Preschoolers' Motor Skills N/A
Active, not recruiting NCT05143294 - Conectar Jugando: Board Games in Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT05267730 - Conectar Jugando: Board Games in Rural Elementary Classrooms (6-12 Years Old) to Improve Executive Functions N/A
Completed NCT03680157 - Comparing Rater Reliability of Familiar Practitioners to Blinded Coders
Completed NCT00362076 - The Role of Motion in Infants' Ability to Categorize N/A
Recruiting NCT05525962 - Vulnerability/Resilience Factors Influencing the Developmental Trajectories and Adaptive Methods of Children and Adolescents in Child Welfare System.
Completed NCT03232606 - Physical Activity of Asthmatic Children
Completed NCT05955755 - The Effect of Butterfly Vacuum Blood Collection Set and Standard Vacutanier Needle on the Level of Pain and Fear N/A
Recruiting NCT04443855 - WASH Benefits Child Development Follow up N/A
Not yet recruiting NCT06335524 - Infant-Maternal Partnership and Cognitive Training Study for Preterm Infants N/A
Not yet recruiting NCT05783141 - Prebiotic Effects in Healthy Toddlers N/A
Completed NCT02539251 - Arabic Ages and Stages Questionnaire-III
Completed NCT02800616 - The Healthy Elementary School of the Future N/A
Completed NCT02451059 - Reducing Socioeconomic Disparities in Health at Pediatric Visits N/A
Completed NCT02242539 - Tools to Improve Parental Recognition of Developmental Deficits in Children N/A
Completed NCT03010306 - CASITA Intervention for Children at Risk of Delay in Carabayllo, Peru N/A
Completed NCT01683565 - Preemie Tots: A Pilot Study to Understand the Effects of Prematurity in Toddlerhood Phase 4
Completed NCT00989859 - Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Recruiting NCT00980733 - Efficacy of Micronutrient Fortified Yoghurt in School Children for Health Benefits Phase 3
Terminated NCT04347707 - Building Regulation in Dual Generations N/A