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Oculomotor Training and Chinese Characters Recognition in Children With Neuromuscular Disease (yes)

Primary Purpose

Extraocular Muscle Disorder, Neuromuscular Diseases

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
gaze-directed oculomotor training
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extraocular Muscle Disorder focused on measuring gaze-directed oculomotor training, reading in Chinese

Eligibility Criteria

6 Years - 8 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • schoolchildren with neuromuscular disease associated with oculomotor anomalies,
  • study in primary school of normal intelligence;
  • age 6 to 8 years old;
  • with native language in Chinese and Cantonese;
  • because of pure oculomotor training, subjects with aphasia may also be recruited;
  • students with normal to mild visual impairment (best corrected visual acuity is better than 20/60);and
  • both eyes without visual loss as Tobii X3-120 seek binocular vision for calibration and assessment.

Exclusion Criteria:

  • students with mild to moderate intellectual disability;
  • students unable to read Chinese or unable to understand spoken Cantonese;
  • student without oculomotor anomalies who are expected to have accurate fixation and saccades; or student with moderate to severe visual impairment; and
  • students with ADHD, ASD or with behaviour challenging and attention problems, and/or with epileptic seizure elicited by computer flickering light.

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

gaze-directed oculomotor training

control

Arm Description

device: Tobii PCEye Treatment group went through the oculomotor training with a gaze-pointer interface (Tobii PC Eye) in reading in Chinese.

No intervention: participants in control read ordinary Chinese textbooks.

Outcomes

Primary Outcome Measures

adjusted horizontal reading time
number of corrected fixation per total visit duration of 80 Area of interest (AOI). It was tested by the Developmental Eye Movement test, subtest C.

Secondary Outcome Measures

saccade accuracy
number of correct saccade sequence (5 AOI) per 16 lines
Chinese characters recognition accuracy of grade-leveled readings
percentage of correct answer per 10 multiple choice questions, select 1 out of 10

Full Information

First Posted
March 27, 2018
Last Updated
August 8, 2018
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03627962
Brief Title
Oculomotor Training and Chinese Characters Recognition in Children With Neuromuscular Disease
Acronym
yes
Official Title
Using Gaze-directed Oculomotor Training (GDOMT) to Enhance Reading-related Oculomotor Skills and Chinese Characters Recognition CCR) for Children With Neuromuscular Disease (NMD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
April 30, 2017 (Actual)
Study Completion Date
August 8, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the effects of gaze-directed oculomotor training incorporated with web-based curriculum readings in Chinese to enhancing fixation, saccade and Chinese characters recognition in schoolchildren with neuromuscular disease associated with congenital oculomotor anomalies.
Detailed Description
Background: schoolchildren with neuromuscular diseases associated with congenital oculomotor anomalies find problems in reading, even found difficulties in learning their mother-tongue language of Chinese. Objectives: (1) To test the hypothesis of using gaze-directed oculomotor training (GDOMT) incorporated with curriculum-based reading platform might enhance reading-related oculomotor skills and Chinese characters recognition; (2) To validate the outcome parameters of reading-related oculomotor skills by using remote eye tracker. Hypothesis: It has been shown that motor learning theory were effective in motor training for children with neuromuscular diseases. Oculomotor training to re-gain reading skills has been found effective for person with acquired brain injury or children with dyslexia, but there is no study on oculomotor training in children with neuromuscular diseases for reading. In this study, we hypothesize that self-initiated gaze-directed oculomotor training via e-reading platform (activated by horizontal saccade from left to right, then fixation dwell about 500ms to activate read-aloud the words phrases in Cantonese) for children with neuromuscular diseases associated with extra-ocular muscles anomalies, will be improved accuracy in fixation and saccade. Design: Cross-centers prospective Cohort study with quasi-experimental design; subjects of aged 6 to 8, randomly assigned into age-matched treatment group (N=10) or the age-matched control group (N=11). Methods: Participants (aged 6 to 8) with neuromuscular diseases, ocular health normal, normal intelligence, studying in main-stream special schools for children with physically disabilities were recruited. Participants passed the vision screening then randomized to age-paired matched control group (N=11) and treatment group (N=10). After time 1 measure, they attended reading class as usual. Therapists or teaching staff brought participants to library one by one and let the participant to read hardcopy or e-reading as assigned control or treatment group. Those therapists and teaching staff involved in training did not involve in repeated measures. Both groups explored to their curriculum-based reading materials. Participants of treatment group received oculomotor training by means of using a gaze-pointer interface to activate a reading e-platform, while control group used some ordinary hardcopy printout as placebo. Training sessions were provided twice per week for eight consecutive school calendar weeks. Occupational therapists and teachers collaborated in the reading class throughout 8 weeks. Participant in treatment group sat in front of the computer with the access hardware PCEye, gaze-directed oculomotor training was facilitated by decreasing the visual span from 20 to 10 to 5 degrees per words phrase. Teacher presented the web-based reading materials in hardcopies (placebo) to control group. Teacher pointed to the passages and read aloud to individual. Both treatment group and control group have same dosage of reading. Control group performed the Chinese characters recognition test by gesture or verbal responses to the printout of web-based materials, while treatment group used gaze-access to select the answers same as Developmental Eye Movement Sub-test C.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraocular Muscle Disorder, Neuromuscular Diseases
Keywords
gaze-directed oculomotor training, reading in Chinese

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
gaze-directed oculomotor training
Arm Type
Experimental
Arm Description
device: Tobii PCEye Treatment group went through the oculomotor training with a gaze-pointer interface (Tobii PC Eye) in reading in Chinese.
Arm Title
control
Arm Type
No Intervention
Arm Description
No intervention: participants in control read ordinary Chinese textbooks.
Intervention Type
Other
Intervention Name(s)
gaze-directed oculomotor training
Other Intervention Name(s)
Tobii PCEye
Intervention Description
Device: Tobii PCEye Protocol: Visual span was calculated by the distance between human-computer and dpi of fonts. Pointer speed was programmed 120pixels (5 degrees)/1sec for image drift of reading. Dosage: 1) gaze-access required 20 to 10 degrees per fixation to activate text-to-speech (TTS) read-aloud function; about 30 repetitions of saccade and fixation. 2) gaze-directed OMT limited to 10-5 degrees. Chinese characters recognition in multiple choice format, about 60 repetitions. Target behavior - gaze-directed access by Tobii PCEye: reading from left to right (=horizontal mouse mover); read-aloud function by gaze dwell > 500ms. To enhance purposeful and repetitive eye movement. Frequency: 2 session/wk x 8 wks Duration: 30 min/session
Primary Outcome Measure Information:
Title
adjusted horizontal reading time
Description
number of corrected fixation per total visit duration of 80 Area of interest (AOI). It was tested by the Developmental Eye Movement test, subtest C.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
saccade accuracy
Description
number of correct saccade sequence (5 AOI) per 16 lines
Time Frame
24 weeks
Title
Chinese characters recognition accuracy of grade-leveled readings
Description
percentage of correct answer per 10 multiple choice questions, select 1 out of 10
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: schoolchildren with neuromuscular disease associated with oculomotor anomalies, study in primary school of normal intelligence; age 6 to 8 years old; with native language in Chinese and Cantonese; because of pure oculomotor training, subjects with aphasia may also be recruited; students with normal to mild visual impairment (best corrected visual acuity is better than 20/60);and both eyes without visual loss as Tobii X3-120 seek binocular vision for calibration and assessment. Exclusion Criteria: students with mild to moderate intellectual disability; students unable to read Chinese or unable to understand spoken Cantonese; student without oculomotor anomalies who are expected to have accurate fixation and saccades; or student with moderate to severe visual impairment; and students with ADHD, ASD or with behaviour challenging and attention problems, and/or with epileptic seizure elicited by computer flickering light.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carly SY Lam, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Study Director
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

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Oculomotor Training and Chinese Characters Recognition in Children With Neuromuscular Disease

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