Cerebral PalsyCP-HYDRO-RETRONCT07907445
Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy
An observational study of Cerebral Palsy, run by Karabuk University at 1 site in Turkey (Türkiye).
Trial summary
This retrospective observational study aims to describe changes in land-based motor function recorded before and after routine hydrotherapy among children with cerebral palsy. Existing clinical records from a special education and rehabilitation center in Safranbolu, Türkiye, covering September 1, 2021 through August… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Routine Hydrotherapy (Aquatic Rehabilitation)
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with cerebral palsy who attended a special education and rehabilitation center in Safranbolu, Türkiye and received routinely prescribed hydrotherapy between September 1, 2021 and August 31, 2026. All consecutively identified records meeting the prespecified eligibility requirements will be reviewed.
Who may be able to join
- Documented diagnosis of cerebral palsy in the clinical record.
- Younger than 18 years of age at the beginning of the indexed hydrotherapy course.
- At least one dated hydrotherapy course recorded during September 1, 2021-August 31, 2026.
- Comparable land-based assessments using the GMFM-66 before and after the indexed hydrotherapy course.
Who cannot join
- Cerebral palsy diagnosis or receipt of hydrotherapy cannot be verified from the record.
- Only one of the two required pre- or post-course measurements is available.
- Pre- and post-course measurements are not comparable or the primary change score cannot be calculated because of incomplete or inconsistent documentation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ozel Safranbolu Ozel Egitim ve Rehabilitasyon Merkezi
Safranbolu, Karabük Province
About this study
Official title: Investigation of Changes in Land-Based Motor Function Following Routine Hydrotherapy in Children With Cerebral Palsy: A Retrospective Medical Record Study
This retrospective observational study aims to describe changes in land-based motor function recorded before and after routine hydrotherapy among children with cerebral palsy. Existing clinical records from a special education and rehabilitation center in Safranbolu, Türkiye, covering September 1, 2021 through August 31, 2026, will be reviewed after the required ethics approval and institutional authorization. The study will include children younger than 18 years at the start of a documented hydrotherapy course who have comparable assessments using the Gross Motor Function Measure-66 (GMFM-66) before and after that course. No new intervention, examination, or participant contact is planned for research purposes. Changes in motor performance and their associations with age, Gross Motor Function Classification System level, baseline motor function, and recorded hydrotherapy dose will be evaluated when data permit. As this is an uncontrolled retrospective study, observed changes will not be interpreted as the causal effect of hydrotherapy alone. Approximately 45 eligible children are expected. Record abstraction is planned to begin on November 1, 2026; completion is estimated for April 30, 2027.
Read the detailed description
This single-center retrospective medical record study will examine routinely collected clinical data for children with cerebral palsy who received hydrotherapy as part of usual rehabilitation services at the special education and rehabilitation center in Safranbolu, Türkiye. The source-record period is September 1, 2021 through August 31, 2026. Only clinical records already created during routine care will be used. No randomization, prospectively assigned intervention, additional treatment, new assessment, or laboratory test will be performed.
All consecutive eligible records within the defined period will be screened. Eligible records must document cerebral palsy, hydrotherapy dates, and at least one comparable land-based motor assessment performed before and after the hydrotherapy course using the same assessment instrument. For each child, the first eligible hydrotherapy course will be used in the principal analysis. A baseline measurement will be the nearest eligible land-based assessment before the first session; follow-up will be the first eligible land-based assessment after the last session. Intervals between assessments and treatment dates will be recorded. When adequate data are available, an additional sensitivity analysis will restrict assessments to within 30 days of the beginning and end of the treatment course.
Abstracted variables will include age at hydrotherapy initiation, sex, cerebral palsy subtype, Gross Motor Function Classification System (GMFCS) level, baseline motor function, comorbidities, orthoses and assistive-device use, hydrotherapy session number, frequency, duration, documented content, and concurrent land-based physiotherapy. Records of botulinum toxin injections, orthopedic surgery, and relevant changes in clinical care will be reviewed when available. The prespecified primary outcome is change in land-based GMFM-66 total score. Comparable pre-course and post-course GMFM-66 scores will be used. Scores from other instruments will not be converted into GMFM-66 scores or combined with them.
Within-child change will be calculated as the post-course value minus the pre-course value. Paired t-tests or Wilcoxon signed-rank tests will be used according to the distribution of paired differences, with effect sizes and 95% confidence intervals when estimable. Exploratory analyses will examine associations with age, baseline scores, GMFCS level, recorded hydrotherapy dose, and concurrent rehabilitation, with multivariable models only if sample size and data quality permit. No imputation will be applied for a missing baseline or follow-up primary measurement. Records will be coded, with directly identifying information excluded from the analysis dataset. Reporting will follow STROBE and applicable RECORD recommendations. Due to the retrospective, single-group design, motor changes cannot be attributed solely to hydrotherapy.
The estimated sample is 45 children; all consecutive eligible records in the defined historical period will be screened. Record abstraction will begin on November 1, 2026, with estimated completion by April 30, 2027. This anticipated completion date is a planning estimate and will be updated according to actual progress.
- Conditions
- Cerebral Palsy
- Being tested
- Routine Hydrotherapy (Aquatic Rehabilitation)
- Keywords
- Hydrotherapy, Aquatic Therapy, Gross Motor Function, Motor Skills, Rehabilitation, Retrospective Studies, Physical Therapy Modalities
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Hydrotherapy (Aquatic Rehabilitation)Other
Hydrotherapy previously delivered as part of routine clinical services, not assigned by the researchers. The number of sessions, treatment duration, frequency, and documented session content will be abstracted if available. No standardized research treatment program or new hydrotherapy sessions will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Children With Cerebral Palsy Who Received Routine Hydrotherapy | Children with a recorded diagnosis of cerebral palsy who received hydrotherapy in routine rehabilitation care during the historical record period and have comparable pre- and post-course land-based motor assessments. No control group is included. Receives: Other: Routine Hydrotherapy (Aquatic Rehabilitation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gross Motor Function Measure-66 (GMFM-66) Total Score
Within-child change calculated as the post-hydrotherapy GMFM-66 total score minus the pre-hydrotherapy GMFM-66 total score for the first eligible hydrotherapy course. The GMFM-66 is a 66-item measure of gross motor function in children with cerebral palsy, yielding an interval-level total score from 0 to 100. Higher scores indicate better gross motor function; a positive change indicates improvement. Only comparable routinely recorded land-based GMFM-66 scores will be analyzed.
Measured: Nearest assessment before the first session and first eligible assessment after the last session of the first eligible hydrotherapy course; historical records September 2021-August 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karabuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ece ACAR, Karabuk University
- Investigators
- Ece Acar, PhD, Principal investigator, Karabuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907445
- Sponsor's protocol ID
- KBU-CP-HYDRO-RETRO-2026-01
- Acronym
- CP-HYDRO-RETRO
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sorensen HT, von Elm E, Langan SM; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015 Oct 6;12(10):e1001885. doi: 10.1371/journal.pmed.1001885. eCollection 2015 Oct.
PubMed 26440803Ballington SJ, Naidoo R. The carry-over effect of an aquatic-based intervention in children with cerebral palsy. Afr J Disabil. 2018 Oct 29;7(0):361. doi: 10.4102/ajod.v7i0.361. eCollection 2018.
PubMed 30473998Russell DJ, Avery LM, Rosenbaum PL, Raina PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Phys Ther. 2000 Sep;80(9):873-85.
PubMed 10960935Wood E, Rosenbaum P. The gross motor function classification system for cerebral palsy: a study of reliability and stability over time. Dev Med Child Neurol. 2000 May;42(5):292-6. doi: 10.1017/s0012162200000529.
PubMed 10855648
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Changes in Land-Based Motor Function Following Routine Hydrotherapy in Children With Cerebral Palsy: A Retrospective Medical Record Study
- ClinicalTrials.gov ID
- NCT07907445
- Acronym / sponsor ID
- CP-HYDRO-RETRO / KBU-CP-HYDRO-RETRO-2026-01
- Conditions
- Cerebral Palsy
- Keywords
- Hydrotherapy, Aquatic Therapy, Gross Motor Function, Motor Skills, Rehabilitation, Retrospective Studies, Physical Therapy Modalities
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Karabuk UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 30 Oct 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 retrospective observational study aims to describe changes in land-based motor function recorded before and after routine hydrotherapy among children with cerebral palsy. Existing clinical records from a special education and rehabilitation center in Safranbolu, Türkiye, covering September 1, 2021 through August 31, 2026, will be reviewed after the required ethics approval and institutional authorization. The study will include children younger than 18 years at the start of a documented hydrotherapy course who have comparable assessments using the Gross Motor Function Measure-66 (GMFM-66) before and after that course. No new intervention, examination, or participant contact is planned for research purposes. Changes in motor performance and their associations with age, Gross Motor Function Classification System level, baseline motor function, and recorded hydrotherapy dose will be evaluated when data permit. As this is an uncontrolled retrospective study, observed changes will not be interpreted as the causal effect of hydrotherapy alone. Approximately 45 eligible children are expected. Record abstraction is planned to begin on November 1, 2026; completion is estimated for April 30, 2027.
Detailed description
This single-center retrospective medical record study will examine routinely collected clinical data for children with cerebral palsy who received hydrotherapy as part of usual rehabilitation services at the special education and rehabilitation center in Safranbolu, Türkiye. The source-record period is September 1, 2021 through August 31, 2026. Only clinical records already created during routine care will be used. No randomization, prospectively assigned intervention, additional treatment, new assessment, or laboratory test will be performed.
All consecutive eligible records within the defined period will be screened. Eligible records must document cerebral palsy, hydrotherapy dates, and at least one comparable land-based motor assessment performed before and after the hydrotherapy course using the same assessment instrument. For each child, the first eligible hydrotherapy course will be used in the principal analysis. A baseline measurement will be the nearest eligible land-based assessment before the first session; follow-up will be the first eligible land-based assessment after the last session. Intervals between assessments and treatment dates will be recorded. When adequate data are available, an additional sensitivity analysis will restrict assessments to within 30 days of the beginning and end of the treatment course.
Abstracted variables will include age at hydrotherapy initiation, sex, cerebral palsy subtype, Gross Motor Function Classification System (GMFCS) level, baseline motor function, comorbidities, orthoses and assistive-device use, hydrotherapy session number, frequency, duration, documented content, and concurrent land-based physiotherapy. Records of botulinum toxin injections, orthopedic surgery, and relevant changes in clinical care will be reviewed when available. The prespecified primary outcome is change in land-based GMFM-66 total score. Comparable pre-course and post-course GMFM-66 scores will be used. Scores from other instruments will not be converted into GMFM-66 scores or combined with them.
Within-child change will be calculated as the post-course value minus the pre-course value. Paired t-tests or Wilcoxon signed-rank tests will be used according to the distribution of paired differences, with effect sizes and 95% confidence intervals when estimable. Exploratory analyses will examine associations with age, baseline scores, GMFCS level, recorded hydrotherapy dose, and concurrent rehabilitation, with multivariable models only if sample size and data quality permit. No imputation will be applied for a missing baseline or follow-up primary measurement. Records will be coded, with directly identifying information excluded from the analysis dataset. Reporting will follow STROBE and applicable RECORD recommendations. Due to the retrospective, single-group design, motor changes cannot be attributed solely to hydrotherapy.
The estimated sample is 45 children; all consecutive eligible records in the defined historical period will be screened. Record abstraction will begin on November 1, 2026, with estimated completion by April 30, 2027. This anticipated completion date is a planning estimate and will be updated according to actual progress.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children With Cerebral Palsy Who Received Routine Hydrotherapy | – | Other: Routine Hydrotherapy (Aquatic Rehabilitation)Children with a recorded diagnosis of cerebral palsy who received hydrotherapy in routine rehabilitation care during the historical record period and have comparable pre- and post-course land-based motor assessments. No control group is included. |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with cerebral palsy who attended a special education and rehabilitation center in Safranbolu, Türkiye and received routinely prescribed hydrotherapy between September 1, 2021 and August 31, 2026. All consecutively identified records meeting the prespecified eligibility requirements will be reviewed.
Key inclusion criteria (4 listed)
- Documented diagnosis of cerebral palsy in the clinical record.
- Younger than 18 years of age at the beginning of the indexed hydrotherapy course.
- At least one dated hydrotherapy course recorded during September 1, 2021-August 31, 2026.
- Comparable land-based assessments using the GMFM-66 before and after the indexed hydrotherapy course.
Key exclusion criteria (3 listed)
- Cerebral palsy diagnosis or receipt of hydrotherapy cannot be verified from the record.
- Only one of the two required pre- or post-course measurements is available.
- Pre- and post-course measurements are not comparable or the primary change score cannot be calculated because of incomplete or inconsistent documentation.
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 |
|---|---|---|
| Routine Hydrotherapy (Aquatic Rehabilitation)Hydrotherapy previously delivered as part of routine clinical services, not assigned by the researchers. The number of sessions, treatment duration, frequency, and documented session content will be abstracted if available. No standardized research treatment program or new hydrotherapy sessions will be administered. | Other | Children With Cerebral Palsy Who Received Routine Hydrotherapy |
Primary outcome
Change in Gross Motor Function Measure-66 (GMFM-66) Total Score
Time frame: Nearest assessment before the first session and first eligible assessment after the last session of the first eligible hydrotherapy course; historical records September 2021-August 2026
Within-child change calculated as the post-hydrotherapy GMFM-66 total score minus the pre-hydrotherapy GMFM-66 total score for the first eligible hydrotherapy course. The GMFM-66 is a 66-item measure of gross motor function in children with cerebral palsy, yielding an interval-level total score from 0 to 100. Higher scores indicate better gross motor function; a positive change indicates improvement. Only comparable routinely recorded land-based GMFM-66 scores will be analyzed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Background: PubMed 26440803Benchimol EI, Smeeth L, Guttmann A, Harron K, Moher D, Petersen I, Sorensen HT, von Elm E, Langan SM; RECORD Working Committee. The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement. PLoS Med. 2015 Oct 6;12(10):e1001885. doi: 10.1371/journal.pmed.1001885. eCollection 2015 Oct.
- Background: PubMed 30473998Ballington SJ, Naidoo R. The carry-over effect of an aquatic-based intervention in children with cerebral palsy. Afr J Disabil. 2018 Oct 29;7(0):361. doi: 10.4102/ajod.v7i0.361. eCollection 2018.
- Background: PubMed 10960935Russell DJ, Avery LM, Rosenbaum PL, Raina PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Phys Ther. 2000 Sep;80(9):873-85.
- Background: PubMed 10855648Wood E, Rosenbaum P. The gross motor function classification system for cerebral palsy: a study of reliability and stability over time. Dev Med Child Neurol. 2000 May;42(5):292-6. doi: 10.1017/s0012162200000529.
Related trials for Cerebral Palsy
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Not yet recruiting
EFFECT OF ROBOTIC GLOVES TRAINING ON UPPER LIMB COORDINATION, SELECTIVE MOTOR CONTROL AND ACTIVITIES OF DAILY LIVING IN CHILDREN WITH HEMIPARETIC CEREBRAL PALSY.
Hemiplegic Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
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.
Ece Acar, PhD principal investigator
Karabuk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy, run by Karabuk 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 30 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ece Acar, PhD (+90 545 792 5035, eceacar@karabuk.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gross Motor Function Measure-66 (GMFM-66) Total Score (time frame: Nearest assessment before the first session and first eligible assessment after the last session of the first eligible hydrotherapy course; historical records September 2021-August 2026). 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 NCT07907445, which also lists 4 linked publications.
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 30 Oct 2026.