Autism Spectrum DisorderAT&ASDNCT03195244
Aquatic Therapy and Autism Spectrum Disorders
A study testing Aquatic Physical Therapy in people with Autism Spectrum Disorder, run by Sloan W. Rush, MD at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Aquatic Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 12 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Autism Spectrum Disorder
- Being tested
- Aquatic Physical Therapy
- Keywords
- aquatic therapy, hydrotherapy
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Physical TherapyOther
Swim Whisperer's Aquatic Therapy Sessions
| Study group | Role | What they receive |
|---|---|---|
| Observation | No intervention | Not described |
| One-on-one Aquatic Therapy | Active comparator | Not described Receives: Other: Aquatic Physical Therapy |
| Group Aquatic Therapy | Experimental | Not described Receives: Other: Aquatic Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PedsQL Score
Survey
Measured: Baseline and 10 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start12 Jun 2017
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sloan W. Rush, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sloan W. Rush, MD, Panhandle Eye Group, LLP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195244
- Sponsor's protocol ID
- AT&ASD
- Acronym
- AT&ASD
- Status last verified
- Apr 2022
- First submitted
- 12 Jun 2017
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aquatic Therapy and Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT03195244
- Acronym / sponsor ID
- AT&ASD / AT&ASD
- Conditions
- Autism Spectrum Disorder
- Keywords
- aquatic therapy, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sloan W. Rush, MDUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observation | No intervention | – |
| One-on-one Aquatic Therapy | Active comparator | Other: Aquatic Physical Therapy |
| Group Aquatic Therapy | Experimental | Other: Aquatic Physical Therapy |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic Physical TherapySwim Whisperer's Aquatic Therapy Sessions | Other | Group Aquatic Therapy, One-on-one Aquatic Therapy |
Primary outcome
Change in PedsQL Score
Time frame: Baseline and 10 weeks after intervention
Survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Physical Therapy in people with Autism Spectrum Disorder, run by Sloan W. Rush, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PedsQL Score (time frame: Baseline and 10 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2022.