Child Development DisorderNCT05727046
Investigation of the Usability of the Dynamic Scaffolding System
An observational study of Child Development Disorder and Child Development, run by Karadeniz Technical University at 3 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 9 months to 18 years
- Conditions the study is for
- Child Development Disorder, Child Development, Assistive Technology
- How many people
- 100 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 months to 18 years
- All sexes
- Child, Adult
Study population: Children with motor difficulties
Who may be able to join
- Children with motor disabilities
Who cannot join
- If children did not use Dynamic Scaffolding System for less than one month
Trial locations and contacts
3 sites in 1 country.
Turkey (Türkiye)3 sites
Uskudar University
Istanbul, 315662
Uskudar University
Istanbul
Karadeniz Technical University
Trabzon, 5065938882
About this study
Official title: Investigation of the Usability of the Dynamic Scaffolding System An Adaptive Mobility Device in Children With Special Needs and Parental Satisfaction
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.
Read the 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.
- Keywords
- children with disability, assistive device, walker, children, Dynamic Scaffolding System, Parental satisfaction
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After 1 months experience of Dynamic Scaffolding System
Secondary outcomes (1)
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.
Measured: After 1 months experience of Dynamic Scaffolding System
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Turgay Altunalan, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727046
- Sponsor's protocol ID
- KaradenizTechnicalU
- Other IDs
- Beyzanur Dikmen, Melek Vatansever
- Status last verified
- Feb 2023
- First submitted
- 25 Jan 2023
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Usability of the Dynamic Scaffolding System An Adaptive Mobility Device in Children With Special Needs and Parental Satisfaction
- ClinicalTrials.gov ID
- NCT05727046
- Acronym / sponsor ID
- KaradenizTechnicalU
- Keywords
- children with disability, assistive device, walker, children, Dynamic Scaffolding System, Parental satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 months to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with motor difficulties
Key inclusion criteria (1 listed)
- Children with motor disabilities
Key exclusion criteria (1 listed)
- If children did not use Dynamic Scaffolding System for less than one month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Everyday Usage Time of Dynamic Scaffolding System (DSS)
Time frame: After 1 months experience of Dynamic Scaffolding System
Dynamic Scaffolding System is an assistive device for children with special needs. We measure the usage time of DSS by the chronometer.
1 secondary outcome
Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)
Time frame: After 1 months experience of Dynamic Scaffolding System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Development Disorder and Child Development, run by Karadeniz Technical University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Everyday Usage Time of Dynamic Scaffolding System (DSS) (time frame: After 1 months experience of Dynamic Scaffolding System). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.