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Trial record 18 of 5226 for:    neuromuscular disease

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

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ClinicalTrials.gov Identifier: NCT03627962
Recruitment Status : Completed
First Posted : August 14, 2018
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
Carly Lam, The Hong Kong Polytechnic University

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.

Condition or disease Intervention/treatment Phase
Extraocular Muscle Disorder Neuromuscular Diseases Other: gaze-directed oculomotor training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 1, 2016
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : August 8, 2018

Resource links provided by the National Library of Medicine


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 Name: Tobii PCEye

No Intervention: control
No intervention: participants in control read ordinary Chinese textbooks.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. saccade accuracy [ Time Frame: 24 weeks ]
    number of correct saccade sequence (5 AOI) per 16 lines

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627962


Locations
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Hong Kong
The Hong Kong Polytechnic University
Hong Kong, Hong Kong
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Study Director: Carly SY Lam, PhD The Hong Kong Polytechnic University

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Responsible Party: Carly Lam, Principal investigator, Professor Carly SY Lam, PHD, Associate Dean of Faculty of Health and Social Sciences, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03627962     History of Changes
Other Study ID Numbers: HSEARS20160816001
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: August 14, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carly Lam, The Hong Kong Polytechnic University:
gaze-directed oculomotor training, reading in Chinese
Additional relevant MeSH terms:
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Muscular Diseases
Neuromuscular Diseases
Nervous System Diseases
Musculoskeletal Diseases