The Effect of TOAP in Children With CP

NCT07347184 | Completed

• 1 other identifier: AYBIKE-TOAP-CP-CROSSOVER-23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates the effects of a task-oriented aquatherapy program (TOAP) on occupational performance, participation, and motivation in children with cerebral palsy. The program was designed based on each child's individually prioritized occupations identified through the Canadian Occupational Performance Measure (COPM). Twelve children participated in a crossover design. Each child received both the TOAP intervention and conventional rehabilitation exercises in two separate 16-week periods. Interventions were delivered twice per week for 40 minutes per session. Outcomes included occupational performance (COPM), participation (PODCI), and motivation (PMOT). The study aims to provide evidence on whether personalized, meaningful, task-oriented aquatic exercises can improve functional performance and participation in children with cerebral palsy, and to offer structured TOAP protocols for clinicians.

Conditions

Cerebral Palsy (CP)

Keywords

aquatic therapy; occupational therapy; motivation; pool therapy; water exercise therapy

Outcome Measures

Primary Outcomes (3)

• Occupational Performance

  Canadian Occupational Performance Measure (COPM), a client-centered outcome measure that assessing performance (COPM-Performance) in the child's top five occupations. Minimum value:1 Maximum value: 10 Higher score indicates greater performance.

  Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).

• Occupational Satisfaction with Performance

  Canadian Occupational Performance Measure (COPM), a client-centered outcome measure that assessing occupational satisfaction with performance (COPM-Satisfaction) in the child's top five occupations. Minimum value:1 Maximum value: 10 Higher score indicates greater performance.

  baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).

• Participation

  Pediatric Outcomes Data Collection Instrument (PODCI) consists of six subscales. A Global Functioning Score (PODCI-GF) is calculated by summarizing the results of all six subscales. In the present study, participation and overall functional status were evaluated primarily using the PODCI-GF, as it provides a comprehensive representation of the child's overall functional participate. Minimum Value:0 Maximum Value:100 Higher score indicates better overall functioning

  Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).

Secondary Outcomes (1)

• Motivation

  Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).

Study Arms (2)

Study Group

EXPERIMENTAL

Receives tailored occupation-based task-oriented aquatherapy program

Behavioral: Task-Oriented Aquatherapy Program

Control Group

ACTIVE COMPARATOR

Receives conventional rehabilitation exercise program

Other: Conventional Rehabilitation Exercise

Interventions

Task-Oriented Aquatherapy Program BEHAVIORAL

A 16-week program where each child engages in activities tailored to their five most important occupations, identified via COPM. Sessions are 40 minutes, twice weekly, focused on improving occupational performance, participation, and motivation. The program is structured, individualized, and designed to enhance engagement and functional outcomes in children with CP.

Also known as: Study Group Intervention

Study Group

Conventional Rehabilitation Exercise OTHER

Participants received standard rehabilitation exercises including activities to improve gross and fine motor skills, balance, coordination, muscle strength, joint range of motion, and cardiovascular capacity.

Also known as: Control Group Intervention

Control Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with CP classified as GMFCS levels 1-3 and MACS levels 1-3.
• Children and caregivers who voluntarily agreed to participate

You may not qualify if:

• Severe intellectual disability
• MAS levels 3-4
• Surgery or botulinum toxin injection within the past 6 months
• Significant hearing or vision impairment interfering with assessment
• Medical conditions preventing exercise (e.g., cardiovascular failure)
• Conditions preventing aquatic exercise (e.g., infection, open wound, incontinence)

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Altındağ, 06050, Turkey (Türkiye)

Location

Related Publications (1)

• Baykan A., Serebral Palsi Tanılı Çocuklarda Görev Odaklı Su İçi Egzersizin Okupasyonel Performans ve Katılım Üzerine Etkisi, Hacettepe Üniversitesi Sağlık Bilimleri Enstitüsü Ergoterapi Programı Yüksek Lisans Tezi, Ankara, 2023.

  RESULT

Related Links

• Hacettepe University Occupational Therapy Department Thesis Collection

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sedef Şahin, Assoc. Prof.

  Hacettepe University

  STUDY DIRECTOR

• Aybike Baykan, PT, MSc

  Etimesgut Belediyesi Engelsiz Yaşam Özel Eğitim ve Rehabilitasyon Merkezi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome evaluators (COPM, PODCI, PMOT) were blinded to group assignments to reduce assessment bias.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator / Graduate Researcher

Model Details: Two groups receive different interventions for 16 weeks, then switch interventions for another 16 weeks; each child serves as their own control.

Study Record Dates

• First Submitted: December 8, 2025
• First Posted: January 16, 2026
• Study Start: June 6, 2022
• Primary Completion: May 23, 2023
• Study Completion: May 23, 2023
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: IPD and supporting information will be available beginning 6 months after publication of the study results and will remain accessible for 5 years thereafter.
• Access Criteria: Data will be accessible to qualified researchers who submit a methodologically sound proposal. Requests must be reviewed and approved by the principal investigator. Data will be shared via secure transfer under a data use agreement ensuring confidentiality and ethical use.

Locations

TU (1)