NCT06484946

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2019

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5.1 years

First QC Date

June 26, 2024

Last Update Submit

July 1, 2024

Conditions

Keywords

aquatic therapychildrensensory processing challengesaquaticswaterlearn to swimaquatic occupational therapyoccupational therapysensory processing

Outcome Measures

Primary Outcomes (2)

  • Goal Attainment Scaling (GAS)

    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

    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 Outcomes (1)

  • Sensory Processing Measure (SPM: Preschool version: SPM-P, newer edition: SPM-2) Assessment Scores

    Parents completed SPM on their child before the 8-week group began.

Study Arms (1)

Aquatic occupational therapy

EXPERIMENTAL

Each child participated and experienced occupational therapy in the water.

Other: aquatic occupational therapy

Interventions

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

Also known as: occupational therapy, aquatic therapy, social participation
Aquatic occupational therapy

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seven Hills Recreation Center

Seven Hills, Ohio, 44131, United States

Location

MeSH Terms

Conditions

Autism Spectrum DisorderAttention Deficit Disorder with Hyperactivity

Interventions

Occupational TherapyAquatic Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersAttention Deficit and Disruptive Behavior Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHydrotherapyPhysical Therapy Modalities

Study Officials

  • Kristen M Pataki, OTD

    Cleveland State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Every participant participated in the aquatic group so the participant, care provider, and investigator were all aware of the intervention provided--therapy in the water.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Every participant receives the intervention. Each child participates in the 8-week aquatic group.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

June 26, 2024

First Posted

July 3, 2024

Study Start

February 19, 2019

Primary Completion

April 9, 2024

Study Completion

April 9, 2024

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations