Evaluation of the Comparative Efficacy of Aquatherapy Versus Conventional Physiotherapy on Motor Function and Psychosocial Well-Being in Children With Acute Lymphoblastic Leukemia: Protocol for a Randomized Controlled Trial.
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BACKGROUND: Children with acute lymphoblastic leukemia (ALL) undergoing chemotherapy have limited access to rehabilitation support. While rehabilitation on the basis of physiotherapy has been found to enhance psychosocial well-being and motor performance, a viable substitute for this can be aquatherapy. However, no trials have currently evaluated the effectiveness of aquatherapy in this population. OBJECTIVE: We aim to evaluate the comparative efficacy of aquatherapy versus conventional physiotherapy on the motor function and psychosocial well-being of children with ALL. METHODS: We will conduct a parallel, single-blinded (participant-blinded), randomized controlled trial with embedded quantitative analysis. In total, 54 survivors of ALL undergoing chemotherapy will be recruited from the Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. The experimental group will attend a 4-week, thrice-weekly, 45-minute aquatherapy session focusing on exercise-based rehabilitation. The comparison group will receive conventional physiotherapy including standardized exercises. Assessments will be completed at weeks 0 (baseline), 4 (postintervention), and 12 (follow-up). The primary outcome related to motor function will be measured using the timed up and go test and the Pediatric Balance Scale at week 4. Secondary outcomes will include psychosocial well-being measured with the Hospital Anxiety and Depression Scale and functional abilities measured with the Functional Independence Measure for Children (WeeFIM). Health service data, including length of stay in the hospital, hospital readmissions, and emergency department presentations, will be recorded. Semistructured interviews will be completed within an interpretive description framework to explore participant descriptions. The primary outcome will be analyzed using linear mixed effects models. RESULTS: The trial is scheduled to commence in October 2025. CONCLUSIONS: The trial will inform future implementation of rehabilitation for children with ALL by providing important data regarding the efficacy of aquatherapy compared with conventional physiotherapy as well as patient experience. TRIAL REGISTRATION: Clinical Trials Registry - India CTRI/2025/03/083036; https://tinyurl.com/v446cd6z. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/75877.