NCT05192993

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 14, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

January 14, 2022

Status Verified

December 1, 2021

Enrollment Period

2 months

First QC Date

October 21, 2021

Last Update Submit

December 31, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 1. modreate positive Gaze stable,slightely irregular head movement 2. strong positive Gaze repeatedly unstable ,head movement slow and irregular

    6 weeks

Secondary Outcomes (1)

  • eye head coordination

    6 weeks

Other Outcomes (1)

  • saccadic eye movement

    6 weeks

Study Arms (3)

visual motor integration group

EXPERIMENTAL

participants in the experimental group will receive visual motor integration program

Other: visual motor integration group

Handwriting intervention group

ACTIVE COMPARATOR

participants in the experimental group will receive handwriting intervention program.

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.

Other: visual motor integration program and Handwriting intervention programs

Interventions

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

visual motor integration group

(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

Handwriting intervention 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 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

visual motor integration and Handwriting intervention group

Eligibility Criteria

Age5 Years - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Mild autism (score 55-71) on Gilliam Autism Rating Scale (GARS-3).
  • Intelligence quotient (IQ) score 70-100.
  • Writing difficulties

You may not qualify if:

  • Middle ear disorders
  • Physical or mental conditions that may affect handwriting (e.g., seizures)
  • Uncorrected visual or hearing impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Misr university for science and technology

Cairo, P.O. Box:77, Egypt

Location

Related 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.

    PMID: 30838491BACKGROUND

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Samah M Sheha, PhD

    Misr University for Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 21, 2021

First Posted

January 14, 2022

Study Start

January 1, 2022

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

January 14, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations