CClinicalTrials.gg
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

Who can participate

Ages eligible
3 Years to 17 Years
Sexes eligible
All
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
04

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

05

What researchers measure

Primary outcomes

  1. Change in PedsQL Score

    Survey

    Time frame: Baseline and 10 weeks after intervention

06

Study locations

1 site
  • Turn Center
    Amarillo, Texas 79106, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion