NCT02584972

Brief Summary

Lately, many researchers have found that Children with autism spectrum disorder (ASD) are most likely to have gross motor deficiencies such as lack of coordination in gait and balance. Much has been researched on etiology and motor learning, but only very few researches have examined and analyzed quantitatively gait and balance in ASD. The aim of this research is to analyze quantitatively balance, gait and balance during perturbation in children with ASD and to compare with typically developed children (TD). A group of 20 children diagnosed with ASD and a control group of 20 TD children will be recruited and tested in the laboratory with well-established measures of gait and balance function. They will be instructed to stand as still as possible on a force plate with different task conditions : (1) standing with the eyes open (EO) - standing upright viewing an "X" displayed on a screen 3 meters in front of them; (2) eyes closed (EC) - same as (1) with the eyes closed and covered by blindfolds (i.e. no visual information). (3) Same as 1 standing on foam (i.e., conflicting proprioceptive information). Gait will be measured using the narrow base walk test, modified for clinical use. Participants will be asked to walk within a narrow path 6 meters long . The statistical analysis will include Independent T-tests to compare the ASD and controls with respect to different characteristics. General Linear Model (GLM) will be used by applying a separate model where the dependent variables will be the average values of the postural stability or gait stability parameters (continuous) and the independent variables were categorical by the group and task condition.

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 all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

1.9 years

First QC Date

October 18, 2015

Last Update Submit

July 29, 2021

Conditions

Keywords

Postural controlGaitChildrenAutism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • postural stability measures

    baseline

Secondary Outcomes (1)

  • 6 meter Narrow Path Walking Test

    baseline

Study Arms (2)

children with Autism Spectrum Disorder

no intervention required

Other: no intervention required

heathy children

no intervention required

Other: no intervention required

Interventions

no intervention required

children with Autism Spectrum Disorderheathy children

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children with autism spectrum disorder

You may qualify if:

  • children with autism spectrum disorder
  • years old
  • able to walk independently

You may not qualify if:

  • ASD children who were diagnosed with neurological, orthopedic, or psychiatric diagnoses according to DSM-IV criteria that can affect motor control and postural stability;
  • cerebral palsy; - neuropathic diseases;
  • limb fracture;
  • head trauma during the previous year;
  • who had an IQ score below the normal range (\<70), as assessed by the Wechsler Intelligence Scale for Children - Revised (Wisc-R) administered by a child psychologist.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ben-guion University of the Negev,

Beersheba, 84105, Israel

Location

Soroka University Medical Center

Beersheba, Israel

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Itshak Melzer, Phd

    Ben-Gurion University of the Negev

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 18, 2015

First Posted

October 23, 2015

Study Start

November 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 30, 2021

Record last verified: 2021-07

Locations