Effect of Oculomotor Exercise on Writing Capabilities on Autism
Primary Purpose
Autism
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
visual motor integration group
Handwriting intervention programs
visual motor integration program and Handwriting intervention programs
Sponsored by
About this trial
This is an interventional treatment trial for Autism
Eligibility Criteria
Inclusion Criteria:
- Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
- Intelligence quotient (IQ) score 70-100.
- Writing difficulties
Exclusion Criteria:
- Middle ear disorders
- Physical or mental conditions that may affect handwriting (e.g., seizures)
- Uncorrected visual or hearing impairments.
Sites / Locations
- Misr university for science and technology
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
visual motor integration group
Handwriting intervention group
visual motor integration and Handwriting intervention group
Arm Description
participants in the experimental group will receive visual motor integration program
participants in the experimental group will receive handwriting intervention program.
participants in the group will receive visual motor integration program and handwriting intervention program.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05192993
First Posted
October 21, 2021
Last Updated
December 31, 2021
Sponsor
Misr University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05192993
Brief Title
Effect of Oculomotor Exercise on Writing Capabilities on Autism
Official Title
Effect of Oculomotor and Gaze Stability Exercise on Writing Capabilities on Autism
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
March 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Misr University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
visual motor integration group
Arm Type
Experimental
Arm Description
participants in the experimental group will receive visual motor integration program
Arm Title
Handwriting intervention group
Arm Type
Active Comparator
Arm Description
participants in the experimental group will receive handwriting intervention program.
Arm Title
visual motor integration and Handwriting intervention group
Arm Type
Active Comparator
Arm Description
participants in the group will receive visual motor integration program and handwriting intervention program.
Intervention Type
Other
Intervention Name(s)
visual motor integration group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Handwriting intervention programs
Intervention Description
(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
Intervention Type
Other
Intervention Name(s)
visual motor integration program and Handwriting intervention programs
Intervention Description
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
Primary Outcome Measure Information:
Title
gaze stability
Description
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
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
eye head coordination
Description
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.
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
saccadic eye movement
Description
0= negative Smooth, percise, fast eye movements,fast change of gaze direction,head remain stable
moderately positive slightely irregular eye movements.Short stops before changing gaze direction.Head slightly unstable
strongly positive Eye movements clearly slower or irregular.Prolonged maintenance of gaze direction before changing direction.Obvious head movement.Test cannot be performed.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
Intelligence quotient (IQ) score 70-100.
Writing difficulties
Exclusion Criteria:
Middle ear disorders
Physical or mental conditions that may affect handwriting (e.g., seizures)
Uncorrected visual or hearing impairments.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samah M Sheha, PhD
Organizational Affiliation
Misr University for Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Misr university for science and technology
City
Cairo
ZIP/Postal Code
P.O. Box:77
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30838491
Citation
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.
Results Reference
background
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Effect of Oculomotor Exercise on Writing Capabilities on Autism
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