An observational study in Cerebral Palsy, sponsored by Karabuk University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Karabuk University · Observational
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.
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.
1,898 studies on the registry are indexed under Cerebral Palsy; 439 are open to participants now.
This study's planned enrollment of 45 is below the median of 63 across 469 observational studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Karabuk University is the lead sponsor of 142 studies on the registry; 39 are open to participants now.
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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.
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Exclusion Criteria:
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.
Other: 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.
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.
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
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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