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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05753345
Other study ID # 2022H0340
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 9, 2023
Est. completion date November 30, 2024

Study information

Verified date April 2024
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 36
Est. completion date November 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 3 Years to 9 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Erika Kemp Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Franklin County Board of Developmental Disabilities

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Water Orientation Test Alyn (WOTA) performance based swim skill assessment Baseline, immediately after the intervention
Primary 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
Primary Change in Quality of Upper Extremity Skills Test (QUEST) performance-based assessment of upper extremity skills baseline, immediately after intervention
Secondary Change in Participation and Environment Measure (PEM-CY) parent reported questionnaire of participation in home, school and community baseline, immediately after the intervention
Secondary Change in Canadian Occupational Performance Measure (COPM) Parent perception of goals attained baseline, immediately after the intervention
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