- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06484946
Pediatric Aquatic Occupational Therapy for Children With Sensory Processing Challenges
July 1, 2024 updated by: Kristen Pataki
Children with sensory processing challenges participated in an 8-week play-based aquatic program addressing goals on behavior, sensory, and participation.
It is expected that after the 8-week group, the child's goals will improve demonstrating an effective intervention to address sensory difficulties.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
This study examined the effectiveness of an aquatic OT program for children with sensory processing difficulties to develop water readiness skills and improve sensory, behavior, and engagement goals.
Six groups of children with deficits in various sensory systems participated in an 8-week aquatic group led by an occupational therapist and occupational therapy students.
Each week consisted of a 45-minute aquatic group with a 5 min warmup on land, 30 mins of aquatic activities addressing the sensory system of the week, and 10 mins addressing a social activity with peers.
Goals were developed and assessed via the Goal Attainment Scale (GAS).
Parents of the participants were given the Sensory Processing Measure (SPM-2) before beginning.
As a result of participating in the aquatic OT intervention, percentage of goals achieved will be analyzed.
It is expected that this program proves to be beneficial and therefore aquatic OT shows potential for improving sensory processing skills, behavior, and social participation with peers.
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Seven Hills, Ohio, United States, 44131
- Seven Hills Recreation Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Participants must be ages 4-9 years old
- have an identified sensory processing problem as related on the SPM assessment
- able to maintain head, neck, and trunk control
- able to follow 1-2 step directions
Exclusion Criteria:
- Participants younger than 4 years old and older than 9 years old
- requires lift to get in the water
- difficulty with following 1-step directions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Aquatic occupational therapy
Each child participated and experienced occupational therapy in the water.
|
Each week, the children participated in a 45-minute aquatic occupational therapy group that consisted of warmup on land, 30 mins of sensory activities in the water, and 10 mins of social activity in the water
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Goal Attainment Scaling (GAS)
Time Frame: Scores were tracked weekly for 8 weeks of each program.
|
Goals were written on behavior, engagement/participation, and sensory on a scale from -2 (worse outcome) to +2 (better outcome).
Each week scores on each goal were documented.
|
Scores were tracked weekly for 8 weeks of each program.
|
|
Parent Surveys
Time Frame: Parents were given a post-survey at the 8th week.
|
Survey with quantitative and qualitative questions about their child's experience and differences seen in the aquatic group
|
Parents were given a post-survey at the 8th week.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sensory Processing Measure (SPM: Preschool version: SPM-P, newer edition: SPM-2) Assessment Scores
Time Frame: Parents completed SPM on their child before the 8-week group began.
|
Assessment given to parents to fill out before their child could start the aquatic group.
Gives information on different sensory systems.
Categories are: vision, hearing, touch, taste and smell, body awareness, balance and motion, sensory total, planning and ideas, and social participation.
Interpretive range is: Typical, Moderate difficulties, and Severe difficulties.
|
Parents completed SPM on their child before the 8-week group began.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Kristen M Pataki, OTD, Cleveland State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2019
Primary Completion (Actual)
April 9, 2024
Study Completion (Actual)
April 9, 2024
Study Registration Dates
First Submitted
June 26, 2024
First Submitted That Met QC Criteria
July 1, 2024
First Posted (Actual)
July 3, 2024
Study Record Updates
Last Update Posted (Actual)
July 3, 2024
Last Update Submitted That Met QC Criteria
July 1, 2024
Last Verified
July 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cleveland SU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Not sure if other researchers will want access to this data.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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