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

August 8, 2018 updated by: Carly Lam, The Hong Kong Polytechnic University

Using Gaze-directed Oculomotor Training (GDOMT) to Enhance Reading-related Oculomotor Skills and Chinese Characters Recognition CCR) for Children With Neuromuscular Disease (NMD)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: gaze-directed oculomotor training
device: Tobii PCEye Treatment group went through the oculomotor training with a gaze-pointer interface (Tobii PC Eye) in reading in Chinese.
Other: gaze-directed oculomotor training

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

Other Names:
  • Tobii PCEye
No Intervention: control
No intervention: participants in control read ordinary Chinese textbooks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
adjusted horizontal reading time
Time Frame: 24 weeks
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.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
saccade accuracy
Time Frame: 24 weeks
number of correct saccade sequence (5 AOI) per 16 lines
24 weeks
Chinese characters recognition accuracy of grade-leveled readings
Time Frame: 24 weeks
percentage of correct answer per 10 multiple choice questions, select 1 out of 10
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Investigators

  • Study Director: Carly SY Lam, PhD, The Hong Kong Polytechnic University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 30, 2017

Study Completion (Actual)

August 8, 2018

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

August 8, 2018

First Posted (Actual)

August 14, 2018

Study Record Updates

Last Update Posted (Actual)

August 14, 2018

Last Update Submitted That Met QC Criteria

August 8, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSEARS20160816001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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