Extraocular Muscle DisorderyesNCT03627962
Oculomotor Training and Chinese Characters Recognition in Children With Neuromuscular Disease
A study testing gaze-directed oculomotor training in people with Extraocular Muscle Disorder and Neuromuscular Diseases, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Extraocular Muscle Disorder, Neuromuscular Diseases
- What is being tested?
- gaze-directed oculomotor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Nov 2016to 8 Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Being tested
- gaze-directed oculomotor training
- Keywords
- gaze-directed oculomotor training, reading in Chinese
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaze-directed oculomotor trainingOther
Also called Tobii PCEye
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.
- 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
| Study group | Role | What they receive |
|---|---|---|
| gaze-directed oculomotor training | Experimental | device: Tobii PCEye Treatment group went through the oculomotor training with a gaze-pointer interface (Tobii PC Eye) in reading in Chinese. Receives: Other: gaze-directed oculomotor training |
| control | No intervention | No intervention: participants in control read ordinary Chinese textbooks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (2)
saccade accuracy
number of correct saccade sequence (5 AOI) per 16 lines
Measured: 24 weeks
Chinese characters recognition accuracy of grade-leveled readings
percentage of correct answer per 10 multiple choice questions, select 1 out of 10
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Nov 2016
- Primary completion30 Apr 2017
- Study completion8 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraocular Muscle DisorderStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carly Lam, The Hong Kong Polytechnic University
- Investigators
- Carly SY Lam, PhD, Study director, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627962
- Sponsor's protocol ID
- HSEARS20160816001
- Acronym
- yes
- Status last verified
- Aug 2018
- First submitted
- 27 Mar 2018
- Last updated
- 14 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03627962
- Acronym / sponsor ID
- yes / HSEARS20160816001
- Keywords
- gaze-directed oculomotor training, reading in Chinese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Nov 2016 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 8 Aug 2018 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gaze-directed oculomotor training | Experimental | Other: gaze-directed oculomotor trainingdevice: Tobii PCEye Treatment group went through the oculomotor training with a gaze-pointer interface (Tobii PC Eye) in reading in Chinese. |
| control | No intervention | –No intervention: participants in control read ordinary Chinese textbooks. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gaze-directed oculomotor trainingAlso: Tobii PCEyeDevice: 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 | gaze-directed oculomotor training |
Primary outcome
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.
2 secondary outcomes
saccade accuracy
Time frame: 24 weeks
Chinese characters recognition accuracy of grade-leveled readings
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carly SY Lam, PhD study director
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaze-directed oculomotor training in people with Extraocular Muscle Disorder and Neuromuscular Diseases, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adjusted horizontal reading time (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2018.