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Aquatic Therapy for Children With Neuromotor Deficits

Primary Purpose

Cerebral Palsy, Hypoxia, Brain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aquatic therapy
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

3 Years - 9 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 3-9 years for the children, 18+ for the parents/guardians. child with neuro-motor diagnosis (CP, hypoxia, etc.) child impairments in upper extremity function child deficits in performance of self care activities Exclusion Criteria: compromised airway uncontrolled seizures

Sites / Locations

  • Erika KempRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention: aquatic occupational therapy (AquOTic-NM)

Arm Description

aquatic occupational therapy 30 minutes, self care training 15 minutes

Outcomes

Primary Outcome Measures

Change in Water Orientation Test Alyn (WOTA)
performance based swim skill assessment
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
parent reported questionnaire regarding child's self care skills
Change in Quality of Upper Extremity Skills Test (QUEST)
performance-based assessment of upper extremity skills

Secondary Outcome Measures

Change in Participation and Environment Measure (PEM-CY)
parent reported questionnaire of participation in home, school and community
Change in Canadian Occupational Performance Measure (COPM)
Parent perception of goals attained

Full Information

First Posted
February 3, 2023
Last Updated
July 12, 2023
Sponsor
Ohio State University
Collaborators
Franklin County Board of Developmental Disabilities
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1. Study Identification

Unique Protocol Identification Number
NCT05753345
Brief Title
Aquatic Therapy for Children With Neuromotor Deficits
Official Title
Aquatic Therapy for Children With Neuromotor Deficits
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 9, 2023 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Franklin County Board of Developmental Disabilities

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention for children ages 3-9 with neuromotor deficits such as cerebral palsy. The intervention takes place in a warm water therapy pool, twice a week for ten weeks and targets swim safety skills, upper extremity function and self care participation and performance.
Detailed Description
The purpose of this study is to explore the feasibility, fidelity and acceptability of an aquatic therapy assessment and intervention. The intervention will target swim safety skills, upper extremity function and self care participation and performance in children with neuromotor conditions such as cerebral palsy. The study includes an intake evaluation session, twenty sessions of aquatic therapy (twice a week for 10 weeks) and a post evaluation session. This takes place in Columbus, Ohio. Each session will be a combination of land-based self care training and water-based upper extremity exercise and swim skill training. The intervention structure will include the following: Self Care Session: Doffing clothing, preparing for swimming Motor learning aquatic activities guided by individualized goals Self Care session: Towel dry, rinse off, dressing Individualized activities will be planned according to the individualized goals written for each child participant.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Hypoxia, Brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention: aquatic occupational therapy (AquOTic-NM)
Arm Type
Experimental
Arm Description
aquatic occupational therapy 30 minutes, self care training 15 minutes
Intervention Type
Behavioral
Intervention Name(s)
Aquatic therapy
Intervention Description
Children receive aquatic occupational therapy twice a week for 10 weeks. 30 minutes of aquatic therapy in a warm water pool to increase upper extremity function and swim skills; 15 minutes of self care training to increase independence with dressing and showering.
Primary Outcome Measure Information:
Title
Change in Water Orientation Test Alyn (WOTA)
Description
performance based swim skill assessment
Time Frame
Baseline, immediately after the intervention
Title
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)
Description
parent reported questionnaire regarding child's self care skills
Time Frame
baseline, immediately after the intervention
Title
Change in Quality of Upper Extremity Skills Test (QUEST)
Description
performance-based assessment of upper extremity skills
Time Frame
baseline, immediately after intervention
Secondary Outcome Measure Information:
Title
Change in Participation and Environment Measure (PEM-CY)
Description
parent reported questionnaire of participation in home, school and community
Time Frame
baseline, immediately after the intervention
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
Parent perception of goals attained
Time Frame
baseline, immediately after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 3-9 years for the children, 18+ for the parents/guardians. child with neuro-motor diagnosis (CP, hypoxia, etc.) child impairments in upper extremity function child deficits in performance of self care activities Exclusion Criteria: compromised airway uncontrolled seizures
Facility Information:
Facility Name
Erika Kemp
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Kemp, PhD
Phone
614-292-8167
Email
erika.kemp@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Deidentified data maybe shared with researchers

Learn more about this trial

Aquatic Therapy for Children With Neuromotor Deficits

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