Investigation of the Usability of the Dynamic Scaffolding System

NCT ID: NCT05727046

Last Updated: 2023-02-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-12-01

Brief Summary

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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

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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

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Child Development Disorder Child Development Assistive Technology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Children with cerebral palsy and Children with other diagnoses

Of the children with special needs included in the study, 60% were parents of children with cerebral palsy.

40% of the children with special needs included in the study had Hydrocephalus, Arthrogryposis, Multiplex Congenita, Down Syndrome, Microcephaly, Alpha-thalassemia mental retardation syndrome (ATRX), Spinal Muscular Atrophy (SMA) Type 1, Spinal Muscular Atrophy (SMA) Type 2, L2 hydroxy glutaric aciduria, Prader Willi syndrome, Periventricular leukomalacia grade 1, Hypotonia, Angelman syndrome, Genetic chromosomal abnormality, Dandy-walker syndrome, Western syndrome, Infantile epileptic encephalopathy, Stroke-like migraine attacks after radiation therapy (SMART syndrome), Trigonocephaly, Motor developmental delay, Lissencephaly, Spina bifida, Leigh syndrome and Epilepsy.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Children with motor disabilities

Exclusion Criteria

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

9 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uskudar University

OTHER

Sponsor Role collaborator

Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Turgay Altunalan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Uskudar University

Istanbul, , Turkey (Türkiye)

Site Status

Uskudar University

Istanbul, , Turkey (Türkiye)

Site Status

Karadeniz Technical University

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Beyzanur Dikmen

Identifier Type: OTHER

Identifier Source: secondary_id

Melek Vatansever

Identifier Type: OTHER

Identifier Source: secondary_id

KaradenizTechnicalU

Identifier Type: -

Identifier Source: org_study_id

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