NCT05072418

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 26, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

1.6 years

First QC Date

September 28, 2021

Last Update Submit

September 12, 2024

Conditions

Keywords

child with dyslexia, postural swayvisual perception

Outcome Measures

Primary Outcomes (1)

  • Postural sway analysis

    Root mean squared sway amplitude and sample entropy along the AP and ML axes

    through study completion, an average of 1 year

Secondary Outcomes (1)

  • Stabilogram diffusion analysis of central of pressure

    through study completion, an average of 1 year

Study Arms (2)

Children with dyslexia

Behavioral: Eye-opened and Eye-closed

Non-dyslexic children

Behavioral: Eye-opened and Eye-closed

Interventions

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.

Children with dyslexiaNon-dyslexic children

Eligibility Criteria

Age8 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Normal IQ(\>85, WISC-III)
  • Children with dyslexia assessed by standard tools, performed by psychological-teachers of special education

You may not qualify if:

  • Attention deficit hyperactivity disorder(ADHD)
  • Neurological or psychiatric abnormalities
  • Developmental coordination disorder(DCD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Chen Kong University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Developmental Disabilities

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 11, 2021

Study Start

December 26, 2020

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

September 19, 2024

Record last verified: 2024-09

Locations