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Postural Control Instability in Children With Mild Autism

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Postural Control Balance Assessment
Sponsored by
Texas Woman's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: children from 7-12 years of age, male or female mild ASD diagnosis (as determined by a medical doctor) capable of ambulating independently. Exclusion Criteria: children with additional neurological problems children with visual problems children unable to tolerate walking or standing barefoot children who have fallen three or more times in the last three months children with vestibular problems.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Balance Assessment Children with Autism

    Arm Description

    Postural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.

    Outcomes

    Primary Outcome Measures

    Postural Stability
    Postural stability was operationally defined by the center of pressure displacement measured by the MatScan® pressure mat. These sensors detect the displacement as the body sways anterior, posterior or laterally (right or left).

    Secondary Outcome Measures

    Full Information

    First Posted
    February 28, 2018
    Last Updated
    December 8, 2022
    Sponsor
    Texas Woman's University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05644366
    Brief Title
    Postural Control Instability in Children With Mild Autism
    Official Title
    Proprioception and Vestibular Alterations Affect Postural Control in Children With Mild Autism: A Pilot Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    August 14, 2014 (Actual)
    Primary Completion Date
    August 14, 2015 (Actual)
    Study Completion Date
    September 14, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Texas Woman's University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Objective: Individuals diagnosed with Autism Spectrum Disorder (ASD) exhibit some type of motor control impairment, for instance, motor apraxia and history of gross motor delay that could lead to increased risk of fall. This pilot research was designed to assess and characterize static postural stability and create a starting point to better understand and describe postural control in children with mild autism. Method: We measured static postural control with center of pressure (COP) displacement in 10 children with mild autism during eight sensory conditions that challenge and cancel the visual, proprioceptive and vestibular systems.
    Detailed Description
    Materials and methods Institutional Review Board (IRB) approval at the University of Puerto Rico, Medical Science Campus has obtained prior the recruitment of the participants. Parents of children diagnosed with mild ASD who were interested in the study called the number on the recruitment flyer. The PI spoke with the parent to assess whether their child qualified for the study based on the following inclusion and exclusion criteria. Balance Assessment Protocol The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions. The first four conditions were executed over a stable surface and consisted of the following: (1) eyes open (EO) -evaluates visual, vestibular and proprioceptive systems, (2) eyes closed (EC) -eliminates visual input, evaluates vestibular and proprioceptive system, (3) eyes open while moving head up and down (at 60 beats per minute) (EO HUD) -evaluates visual and proprioceptive system and alters vestibular input, (4) eyes closed while moving the head up and down (EC HUD) -evaluates the effect of removing visual information, and the vestibular input being altered. The subjects then performed the same four tasks, this time standing on an unstable platform (high quality closed cell foam 19 inches long x 15 inches width x 2.25 inches)with the purpose of altering the proprioceptive input and increasing dependence on the visual and vestibular systems.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    The balance assessment procedure included the following; each subject was instructed to stand on both feet for 15 seconds on the pressure MatScan under eight different conditions.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Balance Assessment Children with Autism
    Arm Type
    Experimental
    Arm Description
    Postural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.
    Intervention Type
    Other
    Intervention Name(s)
    Postural Control Balance Assessment
    Intervention Description
    Postural Stability Testing Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks.
    Primary Outcome Measure Information:
    Title
    Postural Stability
    Description
    Postural stability was operationally defined by the center of pressure displacement measured by the MatScan® pressure mat. These sensors detect the displacement as the body sways anterior, posterior or laterally (right or left).
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: children from 7-12 years of age, male or female mild ASD diagnosis (as determined by a medical doctor) capable of ambulating independently. Exclusion Criteria: children with additional neurological problems children with visual problems children unable to tolerate walking or standing barefoot children who have fallen three or more times in the last three months children with vestibular problems.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Martin G. Rosario, PT, PhD
    Organizational Affiliation
    Texas Woman's University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17467940
    Citation
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    Citation
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    Citation
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    Citation
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    Citation
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    Citation
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    Postural Control Instability in Children With Mild Autism

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