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
About this trial
This is an interventional screening trial for Autism Spectrum Disorder
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.
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
NCT ID
NCT05644366
First Posted
February 28, 2018
Last Updated
December 8, 2022
Sponsor
Texas Woman's University
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:
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17467940
Citation
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Postural Control Instability in Children With Mild Autism
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