AutismNCT05192993
Effect of Oculomotor Exercise on Writing Capabilities on Autism
A study testing visual motor integration group, Handwriting intervention programs and visual motor integration program and Handwriting intervention programs in people with Autism, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). Read more about this study
- Who is it for?
- Ages 5 to 8 years
- Conditions the study is for
- Autism
- What is being tested?
- visual motor integration group, Handwriting intervention programs and visual motor integration program and Handwriting intervention programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to Mar 2022
- 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 5 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
- Intelligence quotient (IQ) score 70-100.
- Writing difficulties
Who cannot join
- Middle ear disorders
- Physical or mental conditions that may affect handwriting (e.g., seizures)
- Uncorrected visual or hearing impairments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oculomotor and Gaze Stability Exercise on Writing Capabilities on Autism
Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). In addition to these core deficits, ASD is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. It is therefore not surprising that handwriting difficulties are frequently reported in children with ASD.
Read the detailed description
Handwriting is a functional skill that profoundly affects children's academic and psychosocial development. Difficulties in acquiring and applying these skills subsequently lead to problems such as slow writing and illegible written .Such difficulties may have implications on the child's successful participation in school and play activities, potentially leading to problems in academic performance and lowered self-esteem .Therefore, students with handwriting difficulties are especially prone to frustration, disappointment, and under achievement. The aim of our study is to improve handwriting quality of children with ASD.
- Conditions
- Autism
- Being tested
- visual motor integration group, Handwriting intervention programs, visual motor integration program and Handwriting intervention programs
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
visual motor integration groupOther
Oculomotor exercises as follow:(1) Eye follow with a stationary head 2)Saccadic eye movements 3) Gaze stability 4)Eye/head co-ordination 5)Balancing exercises
Handwriting intervention programsOther
(1)Eye motor coordination (2)position in space(3)coping-figure ground(4)spatial relationship(5)visual closure(6)constancy of shapes(7)far and near coping
visual motor integration program and Handwriting intervention programsOther
Oculomotor exercises as follow:(1) Eye follow with a stationary head 2)Saccadic eye movements 3) Gaze stability 4)Eye/head co-ordination 5)Balancing exercises 6)Eye motor coordination (7)position in space(8)coping-figure ground(9)spatial relationship(10)visual closure(11)constancy of shapes(12)far and near coping
Hand writing intervention as follow (1)Eye motor coordination (2)position in space(3)coping-figure ground(4)spatial relationship(5)visual closure(6)constancy of shapes(7)far and near coping
| Study group | Role | What they receive |
|---|---|---|
| visual motor integration group | Experimental | participants in the experimental group will receive visual motor integration program Receives: Other: visual motor integration group |
| Handwriting intervention group | Active comparator | participants in the experimental group will receive handwriting intervention program. Receives: Other: Handwriting intervention programs |
| visual motor integration and Handwriting intervention group | Active comparator | participants in the group will receive visual motor integration program and handwriting intervention program. Receives: Other: visual motor integration program and Handwriting intervention programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
gaze stability
Rating scale of gaze stability
0= negative Gaze stable smooth well coordinated,percise and fast movement of the head,fluent change of head movement direction
- modreate positive Gaze stable,slightely irregular head movement
- strong positive Gaze repeatedly unstable ,head movement slow and irregular
Measured: 6 weeks
Secondary outcomes (1)
eye head coordination
Rating scale of sequential head and eye movements 0= negative Clear,regular ,smooth, dissociated movements,of head and eyes.
- moderately positive slightely decelerated eye movements.occasional associated eye-head movements ,head unstable.
- strongly positive clearly decelerated , irregular and often associated eye -head movements test not feasible.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start1 Jan 2022
- Primary completionMar 2022 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah Mahmoud Sheha, Misr University for Science and Technology
- Investigators
- Samah M Sheha, PhD, Principal investigator, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192993
- Sponsor's protocol ID
- P.T.REC/012/003283
- Status last verified
- Dec 2021
- First submitted
- 21 Oct 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Accardo AL, Finnegan EG, Kuder SJ, Bomgardner EM. Writing Interventions for Individuals with Autism Spectrum Disorder: A Research Synthesis. J Autism Dev Disord. 2020 Jun;50(6):1988-2006. doi: 10.1007/s10803-019-03955-9.
PubMed 30838491
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oculomotor and Gaze Stability Exercise on Writing Capabilities on Autism
- ClinicalTrials.gov ID
- NCT05192993
- Acronym / sponsor ID
- P.T.REC/012/003283
- Conditions
- Autism
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 14 Jan 2022 (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.
Autism spectrum disorders (ASD)are neurodevelopmental disorders that are clinically characterized by a triad of features: impairments in social interaction, impairments in communication, and presence of restrictive repetitive and stereotypical behaviors, interests, or activities (DSM-IV). In addition to these core deficits, ASD is associated with a high prevalence of fine motor difficulties and executive function impairments that contribute to acquisition and performance of skilled motor tasks. It is therefore not surprising that handwriting difficulties are frequently reported in children with ASD.
Detailed description
Handwriting is a functional skill that profoundly affects children's academic and psychosocial development. Difficulties in acquiring and applying these skills subsequently lead to problems such as slow writing and illegible written .Such difficulties may have implications on the child's successful participation in school and play activities, potentially leading to problems in academic performance and lowered self-esteem .Therefore, students with handwriting difficulties are especially prone to frustration, disappointment, and under achievement. The aim of our study is to improve handwriting quality of children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| visual motor integration group | Experimental | Other: visual motor integration groupparticipants in the experimental group will receive visual motor integration program |
| Handwriting intervention group | Active comparator | Other: Handwriting intervention programsparticipants in the experimental group will receive handwriting intervention program. |
| visual motor integration and Handwriting intervention group | Active comparator | Other: visual motor integration program and Handwriting intervention programsparticipants in the group will receive visual motor integration program and handwriting intervention program. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
- Intelligence quotient (IQ) score 70-100.
- Writing difficulties
Key exclusion criteria (3 listed)
- Middle ear disorders
- Physical or mental conditions that may affect handwriting (e.g., seizures)
- Uncorrected visual or hearing impairments.
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 |
|---|---|---|
| visual motor integration groupOculomotor exercises as follow:(1) Eye follow with a stationary head 2)Saccadic eye movements 3) Gaze stability 4)Eye/head co-ordination 5)Balancing exercises | Other | visual motor integration group |
| Handwriting intervention programs(1)Eye motor coordination (2)position in space(3)coping-figure ground(4)spatial relationship(5)visual closure(6)constancy of shapes(7)far and near coping | Other | Handwriting intervention group |
| visual motor integration program and Handwriting intervention programsOculomotor exercises as follow:(1) Eye follow with a stationary head 2)Saccadic eye movements 3) Gaze stability 4)Eye/head co-ordination 5)Balancing exercises 6)Eye motor coordination (7)position in space(8)coping-figure ground(9)spatial relationship(10)visual closure(11)constancy of shapes(12)far and near coping Hand writing intervention as follow (1)Eye motor coordination (2)position in space(3)coping-figure ground(4)spatial relationship(5)visual closure(6)constancy of shapes(7)far and near coping | Other | visual motor integration and Handwriting intervention group |
Primary outcome
gaze stability
Time frame: 6 weeks
Rating scale of gaze stability 0= negative Gaze stable smooth well coordinated,percise and fast movement of the head,fluent change of head movement direction 1. modreate positive Gaze stable,slightely irregular head movement 2. strong positive Gaze repeatedly unstable ,head movement slow and irregular
1 secondary outcome
eye head coordination
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Background: PubMed 30838491Accardo AL, Finnegan EG, Kuder SJ, Bomgardner EM. Writing Interventions for Individuals with Autism Spectrum Disorder: A Research Synthesis. J Autism Dev Disord. 2020 Jun;50(6):1988-2006. doi: 10.1007/s10803-019-03955-9.
- Individual participant dataSharing planned: No
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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.
Samah M Sheha, PhD principal investigator
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing visual motor integration group, Handwriting intervention programs and visual motor integration program and Handwriting intervention programs in people with Autism, run by Misr University for Science and Technology at 1 site in Egypt.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. 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 Egypt. 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?
Results are not available in the source record.
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?
gaze stability (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05192993, which also lists 1 linked publication.
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 Jan 2022; AzTrials last refreshed its copy on 6 Nov 2026.