- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07707700
Validating a Neurocognitive Remediation Model for Visual-Attentional Pathway in Chinese Developmental Dyslexia
Testing the Visual-Attentional Pathway in Chinese Developmental Dyslexia: A Randomized Controlled Trial to Validate a Neurocognitive Cascade Model of Remediation
Developmental dyslexia is a common and serious specific learning disability affecting up to one in eight children in Hong Kong, with profound consequences for academic success and personal well-being. For children learning to read the visually complex Chinese script, the challenge is particularly intense. A key research challenge is a long-standing "chicken-and-egg" debate: are weaknesses in the brain's fast-processing visual system (Magnocellular-Dorsal deficits) a cause of reading difficulties, or merely a consequence of limited reading practice? This uncertainty has constrained theoretical progress, creating a major barrier to developing effective, evidence-based support for struggling readers beyond traditional linguistic-based methods.
This project is designed to resolve this debate by directly testing if training a core visual-attentional skill can causally improve reading. The approach is built on investigator's strong pilot data, which established a novel "Neurocognitive Cascade Model": a framework suggesting that the integrity of foundational visual processing impacts reading through a sequential chain reaction flowing from visual attention to working memory.
To test the model, investigators will employ a rigorous, assessor-blind randomized controlled trial with 100 Cantonese-speaking children with developmental dyslexia. Participants will be randomly assigned to either an intervention group that plays action video games, scientifically proven to enhance visual attention, or an active control group that plays a different type of non-action, engaging game. This design allows investigators to isolate the specific impact of the visual-attentional training. The investigators will track changes at four time points-before, during, immediately after the intervention, and at a 6-month follow-up-using a multi-level assessment battery, including objective neural signals of visual processing, cognitive skills, and real-world reading performance measured with advanced eye-tracking technology.
This research will deliver new knowledge that is both scientifically and socially impactful. It will provide the first causal evidence for a visual-attentional pathway to reading remediation in Chinese developmental dyslexia, fundamentally shifting theoretical understanding of the disorder from a single, phonological deficit to a more comprehensive, multi-component model. The findings will have a significant translational impact, paving the way for innovative, non-reading-based interventions and new early screening tools. Ultimately, this project will offer a new, evidence-based approach to help children overcome the specific neurocognitive bottlenecks that hinder their ability to learn to read, with the potential to improve educational outcomes for a large and underserved population.
연구 개요
상태
정황
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Tsz Wing Leung, PhD
- 전화번호: +852 27664268
- 이메일: jeffrey.TW.leung@polyu.edu.hk
연구 장소
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Hong Kong, 홍콩
- 모병
- Optometry Research Clinic
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연락하다:
- Tsz Wing Leung, PhD
- 전화번호: +852 27664268
- 이메일: jeffrey.TW.leung@polyu.edu.hk
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Formal diagnosis of dyslexia by an educational or clinical psychologist using the Hong Kong Test of Specific Learning Difficulties in Reading and Writing (HKT-SpLD),39 with a literacy composite score at or below the 10th percentile.
- Non-verbal IQ score ≥ 85 on Raven's Standard Progressive Matrices.
- Normal or corrected-to-normal vision (both eyes logMAR 0.1 or better).
Exclusion Criteria:
History of neurological or psychiatric disorders (e.g., epilepsy, psychosis).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Action Video Game (AVG) Intervention Group
Participants will undergo 12 hours of training with a commercially available AVG (Rabbids: Party of Legends).
The game consists of numerous fast-paced mini-games in which players track multiple objects, respond to unpredictable events, and filter out distractions, thereby placing high demands on visual-spatial attention and attentional control.
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Participants will undergo 12 hours of training with a commercially available AVG (Rabbids: Party of Legends).
This game is a direct successor to the Rayman Raving Rabbids game used in AVG intervention studies and shares its core mechanics.
The game consists of numerous fast-paced mini-games in which players track multiple objects, respond to unpredictable events, and filter out distractions, thereby placing high demands on visual-spatial attention and attentional control.
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가짜 비교기: Active Control (Non-Action Video Game) Group
Using a commercially available city-building and management simulation game (e.g., SimCity), which is engaging and cognitively demanding (requiring planning and resource management).
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Participants will undergo 12 hours of training with SimCity.
To control for non-specific effects (e.g., gaming time, engagement, motivation), this group will play a non-action video game of matched duration and format.
The investigators will use a commercially available city-building and management simulation game (e.g., SimCity), which is engaging and cognitively demanding (requiring planning and resource management).
However, it critically lacks the fast, unpredictable, and attention-intensive elements of action games, ensuring that any observed group differences can be attributed specifically to the visual-attentional training provided by the AVG.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Visual Attention Span
기간: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Cued Number Identification Task: This task assesses the rapid deployment of visual attention.
A string of five numbers (Geneva font, size 24, 98% contrast) is presented for 200 ms, followed by a 50-ms visual cue 1 cm beneath the target number.
Numbers are spaced to subtend a 3.8° visual angle and minimise lateral masking.
The child's task is to verbally report the cued number.
The primary metric is the number of correctly reported targets out of 20 trials.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Verbal Backward Digit Span
기간: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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An experimenter reads a sequence of numbers aloud (e.g., '8-2-5') and the child must mentally reverse the sequence and repeat it back ('5-2-8').
The sequence length progressively increases, placing increasing demands on both the storage and manipulation components of working memory.
The score is the number of correctly recalled sequences.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Coherent Motion Detection
기간: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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This task measures motion processing sensitivity using a random-dot kinematogram.
Stimuli consist of 250 white dots (0.2° diameter; 50 cd/m²) moving at 0.24°/sec within a 5° circular aperture against a dark background (0.02 cd/m²).
During each 400-ms trial, a percentage of 'signal' dots move coherently left or right.
The task is to indicate the direct of the 'signal' dots.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Steady-State Visual Evoked Potentials (ssVEP)
기간: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Participants will view vertically oriented, sinusoidal gratings at 90% contrast.
To target the magnocellular pathway, we will use low spatial frequency (SF) gratings of 0.6 cycles/degree, with high-SF gratings of 6.0 cycles/degree as a control.
Both stimuli will phase-reverse at 7.5 Hz, generating a dominant 15 Hz ssVEP response.
Although fully isolating the parvo- and magnocellular pathways is difficult, this combination of low spatial and high temporal frequency aims to produce a stronger activation of the magnocellular visual pathway.
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Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Silent Reading and Eye Movement
기간: Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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Task: Participants will silently read 20 sentences constructed from age-appropriate, high-frequency Chinese characters (font: 'Free HK Kai', recommended by the Education Bureau). Each 18-character sentence spans two lines, with characters subtending a 2° visual angle. To ensure comprehension, a multiple-choice question will follow each sentence. Acquisition: Participants will be seated 50 cm from the screen with a forehead rest for stability. Eye movements will be recorded using a Tobii Pro Fusion eye-tracker (250 Hz sampling rate) following a successful nine-point calibration. Global Reading Metrics: Reading speed (characters per minute) and comprehension accuracy (%). Eye-Movement Metrics: Mean fixation duration, mean saccade length, and number of regressions |
Baseline measurement on day 1, Mid-Intervention on day 1, within 30 minutes post-Intervention on day 1, and Follow-Up on day 180
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .