- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347184
The Effect of TOAP in Children With CP (TOAP-CP)
The Effect of Task-Oriented Aquatherapy Program (TOAP) on Occupational Performance and Participation in Children With Cerebral Palsy
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study employed an interventional crossover desing to evaluate the effects of a task-oriented aquatherapy program (TOAP) on occupational performance, participate and motivation in children with cerebral palsy. The intervention was grounded in occupational therapy principles and structured according to the Person-Environment-Occupation (PEO) model with an emphasis on meaningful, child-selected occupations performed in an aquatic environment.
Individualized intervention goals were determined prior to the intervention using occupations prioritized by each participant through the Canadian Occupational Performance Measure (COPM). Based on these prioritized occupations, a structured TOAP was developed for each child. The program incorporated task-oriented aquatic activities designed to support functional movement, postural control, balance and engagement while emphasizing active participation and motivation during therapy sessions.
The study consisted of two consecutive 16-week intervention periods. During the first period, one group received the TOAP intervention while the comparison group received conventional rehabilitation exercises commonly used in pediatric neurorehabilitation. Following completion of the first period, the groups crossed over and received the alternate intervention in the second period. This crossover, structure allowed each participant to serve as their own control, thereby reducing inter-individual variability.
All intervention sessions were conducted twice weekly, with each sessions lasting 40 minutes. Interventions were delivered by trained clinicians in an aquatic therapy setting. Outcome assessments were conducted at baseline and at the end of the each intervention period to evaluate changes associated with each treatment condition.
The study protocol was desinged to examine whether a personalized, task-oriented aquatic intervention grounded in meaningful occupations could enhance occupational performance, participation and motivation in children with cerebral palsy and to inform the development of structured aquatic intervention approaches applicable to clinical practice.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Altındağ
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Ankara, Altındağ, Turkey (Türkiye), 06050
- Hacettepe University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children with CP classified as GMFCS levels 1-3 and MACS levels 1-3.
- Children and caregivers who voluntarily agreed to participate
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Receives tailored occupation-based task-oriented aquatherapy program
|
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.
Other Names:
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Active Comparator: Control Group
Receives conventional rehabilitation exercise program
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Occupational Performance
Time Frame: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
|
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
Time Frame: baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
|
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
Time Frame: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Motivation
Time Frame: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
|
Pediatric Motivation Scale (PMOT) consists of 19 items grouped into six subscales assessing different dimensions of motivation. A Total Motivation Score (PMOT-T) is obtained by summing the scores of all six subscales. In the present study, motivation to participate in rehabilitation programs was evaluated primarly using the PMOT-T, as it provides a comprehensive representation of the child's overall motivation toward rehabilitation. Minimum value:19 Maximum value: 114 Higher score indicates greater motivation. |
Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Sedef Şahin, Assoc. Prof., Hacettepe University
- Principal Investigator: Aybike Baykan, PT, MSc, Etimesgut Belediyesi Engelsiz Yaşam Özel Eğitim ve Rehabilitasyon Merkezi
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYBIKE-TOAP-CP-CROSSOVER-23
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified data for each participant, including:
COPM scores (performance and satisfaction) PODCI scores (participation) PMOT scores (motivation) Demographic information (age, sex, GMFCS and MACS levels)
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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