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Postural Control During Walking and Standing Among Children With Autism Spectrum Disorder (PCASD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02584972
Recruitment Status : Unknown
Verified November 2015 by Itshak Melzer, Soroka University Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2015
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Itshak Melzer, Soroka University Medical Center

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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: no intervention required

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Postural Control During Walking and Standing Among Children With Autism Spectrum Disorder
Study Start Date : November 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
children with Autism Spectrum Disorder
no intervention required
Other: no intervention required
no intervention required

heathy children
no intervention required
Other: no intervention required
no intervention required




Primary Outcome Measures :
  1. postural stability measures [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. 6 meter Narrow Path Walking Test [ Time Frame: baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
children with autism spectrum disorder
Criteria

Inclusion Criteria:

  • children with autism spectrum disorder
  • 6-12 years old
  • able to walk independently

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584972


Contacts
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Contact: Itshak Melzer, PhD 972-8-6477725 itzikm@bgu.ac.il
Contact: Zamir Shorer, MD ZamirS@clalit.org.il

Locations
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Israel
Ben-guion University of the Negev,
Beer-Sheva, Israel, 84105
Soroka University Medical Center
Beer-Sheva, Israel
Sponsors and Collaborators
Soroka University Medical Center
Investigators
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Principal Investigator: Itshak Melzer, Phd Ben-Gurion University of the Negev

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Responsible Party: Itshak Melzer, Associate professor, Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT02584972    
Other Study ID Numbers: Sor 274-13 CTIL
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: November 3, 2015
Last Verified: November 2015
Keywords provided by Itshak Melzer, Soroka University Medical Center:
Postural control
Gait
Children
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders