Cerebral Palsy (CP)TOAP-CPNCT07347184
The Effect of TOAP in Children With CP
A study testing Task-Oriented Aquatherapy Program and Conventional Rehabilitation Exercise in people with Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Task-Oriented Aquatherapy Program and Conventional Rehabilitation Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 6 Jun 2022to 23 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children with CP classified as GMFCS levels 1-3 and MACS levels 1-3.
- Children and caregivers who voluntarily agreed to participate
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Task-Oriented Aquatherapy Program, Conventional Rehabilitation Exercise
- Keywords
- aquatic therapy, occupational therapy, motivation, pool therapy, water exercise therapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Oriented Aquatherapy ProgramBehavioural
Also called Study Group Intervention
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.
Conventional Rehabilitation ExerciseOther
Also called Control Group Intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Receives tailored occupation-based task-oriented aquatherapy program Receives: Behavioral: Task-Oriented Aquatherapy Program |
| Control Group | Active comparator | Receives conventional rehabilitation exercise program Receives: Other: Conventional Rehabilitation Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
Secondary outcomes (1)
Motivation
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.
Measured: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start6 Jun 2022
- Primary completion23 May 2023
- Study completion23 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Two groups receive different interventions for 16 weeks, then switch interventions for another 16 weeks; each child serves as their own control.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aybike Baykan, Hacettepe University
- Investigators
- Sedef Şahin, Assoc. Prof., Study director, Hacettepe UniversityAybike Baykan, PT, MSc, Principal investigator, Etimesgut Belediyesi Engelsiz Yaşam Özel Eğitim ve Rehabilitasyon Merkezi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347184
- Sponsor's protocol ID
- AYBIKE-TOAP-CP-CROSSOVER-23
- Acronym
- TOAP-CP
- Status last verified
- Jan 2026
- First submitted
- 8 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
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 at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Task-Oriented Aquatherapy Program (TOAP) on Occupational Performance and Participation in Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT07347184
- Acronym / sponsor ID
- TOAP-CP / AYBIKE-TOAP-CP-CROSSOVER-23
- Conditions
- Cerebral Palsy (CP)
- Keywords
- aquatic therapy, occupational therapy, motivation, pool therapy, water exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups receive different interventions for 16 weeks, then switch interventions for another 16 weeks; each child serves as their own control.
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Behavioral: Task-Oriented Aquatherapy ProgramReceives tailored occupation-based task-oriented aquatherapy program |
| Control Group | Active comparator | Other: Conventional Rehabilitation ExerciseReceives conventional rehabilitation exercise program |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Children with CP classified as GMFCS levels 1-3 and MACS levels 1-3.
- Children and caregivers who voluntarily agreed to participate
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Task-Oriented Aquatherapy ProgramAlso: Study Group InterventionA 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. | Behavioural | Study Group |
| Conventional Rehabilitation ExerciseAlso: Control Group InterventionParticipants 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 | Control Group |
Primary outcome
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.
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.
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
1 secondary outcome
Motivation
Time frame: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Results publicationBaykan 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.
- Hacettepe University Occupational Therapy Department Thesis CollectionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sedef Şahin, Assoc. Prof. study director
Hacettepe University
Aybike Baykan, PT, MSc principal investigator
Etimesgut Belediyesi Engelsiz Yaşam Özel Eğitim ve Rehabilitasyon Merkezi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Task-Oriented Aquatherapy Program and Conventional Rehabilitation Exercise in people with Cerebral Palsy (CP), run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occupational Performance (time frame: Baseline, up to 16 weeks (end of the first period), up to 32 weeks (end of the second period).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07347184, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.