Back to resultsAquatic Therapy and Autism Spectrum Disorders (AT&ASD)
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic Physical Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring aquatic therapy, hydrotherapy
Eligibility 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
Sites / Locations
- Turn Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Experimental
Arm Label
Observation
One-on-one Aquatic Therapy
Group Aquatic Therapy
Arm Description
Outcomes
Primary Outcome Measures
Change in PedsQL Score
Survey
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03195244
Brief Title
Aquatic Therapy and Autism Spectrum Disorders
Acronym
AT&ASD
Official Title
Aquatic Therapy and Autism Spectrum Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 12, 2017 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
April 12, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sloan W. Rush, MD
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
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
aquatic therapy, hydrotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Observation
Arm Type
No Intervention
Arm Title
One-on-one Aquatic Therapy
Arm Type
Active Comparator
Arm Title
Group Aquatic Therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Aquatic Physical Therapy
Intervention Description
Swim Whisperer's Aquatic Therapy Sessions
Primary Outcome Measure Information:
Title
Change in PedsQL Score
Description
Survey
Time Frame
Baseline and 10 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Turn Center
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Aquatic Therapy and Autism Spectrum Disorders
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