Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05302167 - Molehill Mountain Feasibility Study. N/A
Completed NCT04167839 - Effects of Sensory Diets on Children's Sensory Processing Skills, Psychosocial Skills, and Classroom Engagement N/A
Terminated NCT04049981 - Investigation of Mechanisms of Action in Superpower Glass Phase 1/Phase 2
Active, not recruiting NCT06080087 - Implementation Toolkit to Enhance EBP Among Marginalized Families N/A
Recruiting NCT04107064 - Achieving Steady Work Among Adults With Autism Through Specialized Employment Program N/A
Completed NCT03206996 - Exposure Therapy for Auditory Sensitivity in Autism N/A
Completed NCT01914393 - Pediatric Open-Label Extension Study Phase 3
Completed NCT05588570 - Coaching Children With Anxiety and Autism Through Telehealth N/A
Enrolling by invitation NCT06058104 - Evaluating Efficacy of a Digital Game Therapeutic for Children With Autism N/A
Withdrawn NCT02414451 - Trial of Propranolol in Adults and Adolescents With ASD and Predictors of Response N/A
Completed NCT03002363 - The Effects of Video Modeling of Audiological Testing on Pediatric Patient Compliance Phase 1
Completed NCT02911194 - a2 Milk for Autism and Attention-deficit Hyperactivity Disorder (ADHD) N/A
Completed NCT02847182 - Cord Blood Infusion for Children With Autism Spectrum Disorder Phase 2
Completed NCT02708290 - Mental Imagery Therapy for Autism (MITA) - an Early Intervention Computerized Language Training Program for Children With ASD
Completed NCT02720900 - Prebiotic Intervention for Autism Spectrum Disorders N/A
Completed NCT02536365 - Sensory Integration Therapy in Autism: Mechanisms and Effectiveness N/A
Completed NCT02508922 - Trial of Vitamin D3 Supplementation in Paediatric Autism N/A
Recruiting NCT02255565 - Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study Phase 4
Recruiting NCT01836562 - A Clinical Trial to Study the Safety and Efficacy of Bone Marrow Derived Autologous Cells for the Treatment of Autism Phase 1/Phase 2
Completed NCT02154828 - Clinical Evaluation of Integrative Practices Units Infant and Child Care for Unit Children With Typical or Atypical Autism (AUTISM)