Clinical trial NCT03627962: Oculomotor Training and Chinese Characters Recognition in Children With Neuromuscular Disease
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
Overall status: COMPLETED
Phase: NA
Conditions: Extraocular Muscle Disorder
Neuromuscular Diseases
Keywords: gaze-directed oculomotor training, reading in Chinese
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 21
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: adjusted horizontal reading time
timeFrame: 24 weeks
Secondary outcomes:
measure: saccade accuracy
timeFrame: 24 weeks
measure: Chinese characters recognition accuracy of grade-leveled readings
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Carly SY Lam, PhD
role: STUDY_DIRECTOR
References: