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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05192993
Other study ID # P.T.REC/012/003283
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 1, 2022
Est. completion date March 2022

Study information

Verified date December 2021
Source Misr University for Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date March 2022
Est. primary completion date March 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 8 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
visual motor integration group
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 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
visual motor integration program and Handwriting intervention programs
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

Locations

Country Name City State
Egypt Misr university for science and technology Cairo

Sponsors (1)

Lead Sponsor Collaborator
Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other saccadic eye movement 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.
6 weeks
Primary 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
6 weeks
Secondary 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.
6 weeks
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