NCT03613051

Brief Summary

this study is to explore the degree of impairement in movement skills in children with autistic spectrum disorders

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

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

July 19, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

April 1, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

February 26, 2019

Status Verified

July 1, 2018

Enrollment Period

8 months

First QC Date

July 19, 2018

Last Update Submit

February 24, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • assessment of motor skills in autism spectrum disorders through Movement Assessmet Battery for Children test ( M-ABC) , using checklists' method .

    early detection of motor impairement in child with autism and possbillity of prevention .

    baseline

Study Arms (3)

age band one

age band one ( from 3 to 6 years ) we test manual dexterity by posting coins with prefered hand and non prefered hand test balance by jumping on mats

Behavioral: Movement Assessment Battery for children

age band two

age band two ( from 7 to 10 years ) test manual dexterity by threading lace

Behavioral: Movement Assessment Battery for children

age band three

age band three ( from 11 to 18 years ) test manual dexterity by turning pegs test balance by zigzag hopping

Behavioral: Movement Assessment Battery for children

Interventions

this test measures manual dexterity , balance , aiming and catching

age band oneage band threeage band two

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children from age of 3 years to 18 years with autism not having other brain disease

You may qualify if:

  • all children with autism from the age of 3 years to 18 years

You may not qualify if:

  • children less than 3 years , children with neurodegenerative disorders or cerebral palsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Craig F, Lorenzo A, Lucarelli E, Russo L, Fanizza I, Trabacca A. Motor competency and social communication skills in preschool children with autism spectrum disorder. Autism Res. 2018 Jun;11(6):893-902. doi: 10.1002/aur.1939. Epub 2018 Mar 1.

    PMID: 29493892BACKGROUND
  • Purpura G, Fulceri F, Puglisi V, Masoni P, Contaldo A. Motor coordination impairment in children with autism spectrum disorder: a pilot study using Movement Assessment Battery for Children-2 Checklist. Minerva Pediatr. 2020 Feb;72(1):22-29. doi: 10.23736/S0026-4946.16.04633-8. Epub 2016 Oct 12.

    PMID: 27733748BACKGROUND

MeSH Terms

Conditions

Movement Disorders

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System Diseases

Central Study Contacts

dina tharwat, resident

CONTACT

eman fathalla gad, lecturer

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 2, 2018

Study Start

April 1, 2019

Primary Completion

December 1, 2019

Study Completion

April 1, 2020

Last Updated

February 26, 2019

Record last verified: 2018-07