Child Development DisorderNCT05072418
Postural Control Among Children with and Without Dyslexia
An observational study of Child Development Disorder, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language. Read more about this study
- Who is it for?
- Ages 8 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- Child Development Disorder
- What is being tested?
- Eye-opened and Eye-closed
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 26 Dec 2020to 31 Jul 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 8 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants will be 80 Chinese-speaking children between 8 and 12 years of age recruited from elementary schools in Taiwan. Half of the participants will be formally identified as dyslexia by specialists in the field of special education (Table 1), based on formal psycho-educational assessments (Chinese Character Recognition Test (Huang, 2001), Chinese reading diagnostic evaluation, and Wechsler Intelligence Scale for Children 4th Edition-Chinese version.
Who may be able to join
- 1.Normal IQ(>85, WISC-III)
- 2.Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education
Who cannot join
- 1.Attention deficit hyperactivity disorder(ADHD)
- 2.Neurological or psychiatric abnormalities
- 3.Developmental coordination disorder(DCD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Visual Information on Postural Control Among Children with and Without Dyslexia
As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language.
- Conditions
- Child Development Disorder
- Being tested
- Eye-opened and Eye-closed
- Keywords
- child with dyslexia, postural sway, visual perception
- Medical subject headings
- Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye-opened and Eye-closedBehavioural
The participants were instructed to perform six 60-second trials (2 conditions × 3 trials) of maintaining an upright stance on a force plate (Kistler Type 9260A, Switzerland) under the eyes open (EO) and eyes closed (EC) conditions. The order of EO and EC was alternated for each participant, and half of the subjects began with the EO (or EC) condition. For both conditions, the participants stood with their feet 1 cm apart on a force plate and their arms relaxed comfortably at their sides.
| Study group | Role | What they receive |
|---|---|---|
| Children with dyslexia | Not described Receives: Behavioral: Eye-opened and Eye-closed | |
| Non-dyslexic children | Not described Receives: Behavioral: Eye-opened and Eye-closed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postural sway analysis
Root mean squared sway amplitude and sample entropy along the AP and ML axes
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Stabilogram diffusion analysis of central of pressure
Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2021
- Study start26 Dec 2020
- Primary completion31 Jul 2022
- Study completion31 Jul 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072418
- Sponsor's protocol ID
- A-BR-109-041
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Visual Information on Postural Control Among Children with and Without Dyslexia
- ClinicalTrials.gov ID
- NCT05072418
- Acronym / sponsor ID
- A-BR-109-041
- Conditions
- Child Development Disorder
- Keywords
- child with dyslexia, postural sway, visual perception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 26 Dec 2020 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 11 Oct 2021 (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.
As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on the static balance between dyslexic and non-dyslexic children using the Chinese language.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with dyslexia | – | Behavioral: Eye-opened and Eye-closed |
| Non-dyslexic children | – | Behavioral: Eye-opened and Eye-closed |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants will be 80 Chinese-speaking children between 8 and 12 years of age recruited from elementary schools in Taiwan. Half of the participants will be formally identified as dyslexia by specialists in the field of special education (Table 1), based on formal psycho-educational assessments (Chinese Character Recognition Test (Huang, 2001), Chinese reading diagnostic evaluation, and Wechsler Intelligence Scale for Children 4th Edition-Chinese version.
Key inclusion criteria (2 listed)
- 1.Normal IQ(>85, WISC-III)
- 2.Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education
Key exclusion criteria (3 listed)
- 1.Attention deficit hyperactivity disorder(ADHD)
- 2.Neurological or psychiatric abnormalities
- 3.Developmental coordination disorder(DCD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eye-opened and Eye-closedThe participants were instructed to perform six 60-second trials (2 conditions × 3 trials) of maintaining an upright stance on a force plate (Kistler Type 9260A, Switzerland) under the eyes open (EO) and eyes closed (EC) conditions. The order of EO and EC was alternated for each participant, and half of the subjects began with the EO (or EC) condition. For both conditions, the participants stood with their feet 1 cm apart on a force plate and their arms relaxed comfortably at their sides. | Behavioural | Children with dyslexia, Non-dyslexic children |
Primary outcome
Postural sway analysis
Time frame: through study completion, an average of 1 year
Root mean squared sway amplitude and sample entropy along the AP and ML axes
1 secondary outcome
Stabilogram diffusion analysis of central of pressure
Time frame: through study completion, an average of 1 year
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 19 Sep 2024.
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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.
1 site 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, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 2 inclusion and 3 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Postural sway analysis (time frame: through study completion, an average of 1 year). 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 19 Sep 2024.