Aquatic Therapy for Children With Neuromotor Deficits

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Hypoxia, Brain
• Intervention / Treatment: Behavioral: Aquatic therapy

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:

1. Self Care Session: Doffing clothing, preparing for swimming
2. Motor learning aquatic activities guided by individualized goals
3. Self Care session: Towel dry, rinse off, dressing

Individualized activities will be planned according to the individualized goals written for each child participant.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Erika Kemp
      • Contact: Erika Kemp, PhD; Phone Number: 614-292-8167; Email: erika.kemp@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 9 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention: aquatic occupational therapy (AquOTic-NM); aquatic occupational therapy 30 minutes, self care training 15 minutes	Behavioral: Aquatic therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Water Orientation Test Alyn (WOTA)	performance based swim skill assessment	Baseline, immediately after the intervention
Change in Pediatric Evaluation of Disability Index, Computer Adaptive Text (PEDI-CAT)	parent reported questionnaire regarding child's self care skills	baseline, immediately after the intervention
Change in Quality of Upper Extremity Skills Test (QUEST)	performance-based assessment of upper extremity skills	baseline, immediately after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Participation and Environment Measure (PEM-CY)	parent reported questionnaire of participation in home, school and community	baseline, immediately after the intervention
Change in Canadian Occupational Performance Measure (COPM)	Parent perception of goals attained	baseline, immediately after the intervention

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Franklin County Board of Developmental Disabilities

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: February 3, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 26, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Signs and Symptoms, Respiratory; Cerebral Palsy; Hypoxia; Hypoxia, Brain
• Other Study ID Numbers: 2022H0340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Deidentified data maybe shared with researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No