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Not Yet Recruiting NCT07907445

Changes in Land-Based Motor Function After Routine Hydrotherapy in Children With Cerebral Palsy

Conditions: Cerebral Palsy

Sex: All
Ages: 0 Years – 17 Years
Healthy volunteers: No
Enrollment: 45
Sponsor: Karabuk University

Location: Ozel Safranbolu Ozel Egitim ve Rehabilitasyon Merkezi Safranbolu Karabük Province

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 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07907445). StuddyBuddy aggregates publicly available trial information.