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CompletedNCT03195244AT&ASDUpdated Apr 21, 2022

Aquatic Therapy and Autism Spectrum Disorders

An interventional study of Aquatic Physical Therapy in Autism Spectrum Disorder, sponsored by Sloan W. Rush, MD. Completed at 1 site in United States. Open to participants aged 3 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-04-21.

Sponsored by Sloan W. Rush, MD · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
3 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Autism Spectrum Disorder

Keywords

  • aquatic therapy, hydrotherapy
03

In context

Autism Spectrum Disorder

1,724 studies on the registry are indexed under Autism Spectrum Disorder; 500 are open to participants now.

This study's enrollment of 50 is close to the median of 52 across 1,368 interventional studies indexed under Autism Spectrum Disorder.

Browse Autism Spectrum Disorder studies →

Lead sponsor

Sloan W. Rush, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Eligibility criteria:

  • 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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
50 participants (actual)

Study arms

  • No intervention
    Observation
  • Active comparator
    One-on-one Aquatic Therapy

    Other: Aquatic Physical Therapy

  • Experimental
    Group Aquatic Therapy

    Other: Aquatic Physical Therapy

Interventions

  • OtherAquatic Physical Therapy

    Swim Whisperer's Aquatic Therapy Sessions

06

What researchers measure

Primary outcomes

  1. Change in PedsQL Score

    Survey

    Time frame: Baseline and 10 weeks after intervention

07

Study locations

1 site
  • Turn Center
    Amarillo, Texas 79106, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Apr 2022, 58 months.

Of 800 non-industry interventional studies with no phase under Autism Spectrum Disorder, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's 58 months is above that.

Counting every sponsor, half of 823 studies reached it within 25 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 12, 2017
First posted
Jun 22, 2017
StartActual
Jun 12, 2017
Primary completionActual
Apr 12, 2022
CompletionActual
Apr 12, 2022
Last update
Apr 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03195244
Lead sponsor
Sloan W. Rush, MD
Responsible party
Sloan W. Rush, MD (MD, Panhandle Eye Group, LLP) — Sponsor-investigator
First posted
Jun 22, 2017
Start date
Jun 12, 2017
Primary completion
Apr 12, 2022
Completion
Apr 12, 2022
Last update
Apr 21, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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