NCT04696133

Brief Summary

Clinically, infants with Autism spectrum often display gross motor delays in supine, prone, and sitting skills in their first year of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 15, 2020

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
Last Updated

March 8, 2024

Status Verified

March 1, 2024

Enrollment Period

2.2 years

First QC Date

January 3, 2021

Last Update Submit

March 7, 2024

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum DisorderQuality of lifesensory integrationfine motor skills

Outcome Measures

Primary Outcomes (1)

  • Gilliam autism rating scale

    higher the autism index, indicate the probability the individual has autism

    3 months

Secondary Outcomes (1)

  • Bruininks-Oseretsky Test Of Motor Proficiency

    3 months

Study Arms (2)

conventional training

EXPERIMENTAL

children received fine motor exercises

Other: fine motor skills

sensory integration training

EXPERIMENTAL

Children received designed sensory integration program

Other: sensory integration

Interventions

fine motor skillsOTHER

stretching and strengthening exercises in addition to exercises to enhance fine motor skills

conventional training
sensory integrationOTHER

* Tactile stimulation * Proprioceptive stimulation

sensory integration training

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age ranges from 8 to 12 years.
  • Mild to moderate autistic features

You may not qualify if:

  • Significant visual or auditory defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

faculty of physical therapy, Cairo university

Giza, Egypt

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Emam H El-Negamy, professor

    Cairo University

    STUDY CHAIR

  • kamilia saad

    Cairo University

    STUDY DIRECTOR

  • dalia galal

    Cairo university, Egypt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Amira Abd-elmonem, assist Prof. Physiacl therapy for pediatric department, faculty of physical therapy , Cairo university

Study Record Dates

First Submitted

January 3, 2021

First Posted

January 6, 2021

Study Start

March 15, 2020

Primary Completion

May 15, 2022

Study Completion

August 15, 2023

Last Updated

March 8, 2024

Record last verified: 2024-03

Locations

EG(1)