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Aquatic Therapy and Autism Spectrum Disorders (AT&ASD)

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ClinicalTrials.gov Identifier: NCT03195244
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Sloan W. Rush, MD, Panhandle Eye Group, LLP

Brief Summary:
To compare the efficacy of one-on-one versus group-based aquatic therapy on the social interactions, behaviors and physical activities of children with autism spectrum disorders (ASDs).

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Aquatic Physical Therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Aquatic Therapy and Autism Spectrum Disorders
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : February 12, 2020
Estimated Study Completion Date : February 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Observation
Active Comparator: One-on-one Aquatic Therapy Other: Aquatic Physical Therapy
Swim Whisperer's Aquatic Therapy Sessions

Experimental: Group Aquatic Therapy Other: Aquatic Physical Therapy
Swim Whisperer's Aquatic Therapy Sessions




Primary Outcome Measures :
  1. Change in PedsQL Score [ Time Frame: Baseline and 10 weeks after intervention ]
    Survey



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility criteria:

  • DSM-V diagnosis of Autism Spectrum Disorder or DSM-IV diagnosis of Asperger's syndrome or high functioning atypical autism or pervasive development disorder - not otherwise specified or else the typical clinical findings and suspicion of an ASD
  • Treatment naïve to prior aquatic therapy

Exclusion criteria:

  • Not willing to undergo an investigational treatment
  • Unable to cooperate well enough to safely participate in aquatic therapy under the protocol guidelines
  • Known allergies to pool chemicals
  • Other significant co-morbidities which may include (but is not limited to): severe cerebral palsy with low motor function, advanced pulmonary disease, home oxygen requirement, spina bifida with low motor function, permanent feeding tubes, poorly controlled seizure disorder, chronic indwelling urinary catheters or any condition causing severe cognitive impairment

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): NCT03195244


Contacts
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Contact: Bruce Moseley 806-353-3596 bruce@turncenter.org

Locations
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United States, Texas
Turn Center Recruiting
Amarillo, Texas, United States, 79106
Contact: Bruce Moseley    806-353-3596    bruce@turncenter.org   
Sponsors and Collaborators
Sloan W. Rush, MD

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Responsible Party: Sloan W. Rush, MD, MD, Panhandle Eye Group, LLP
ClinicalTrials.gov Identifier: NCT03195244     History of Changes
Other Study ID Numbers: AT&ASD
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sloan W. Rush, MD, Panhandle Eye Group, LLP:
aquatic therapy, hydrotherapy
Additional relevant MeSH terms:
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Disease
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders