Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 12, 2025
Date Accepted: May 5, 2025
Evaluation of Comparative Efficacy of Aqua-therapy Versus Conventional Physiotherapy on Motor Function and Psychosocial Well Being in Children with Acute Lymphoblastic Leukaemia: Protocol for a Randomised Controlled Trial
ABSTRACT
Background:
Access to rehabilitation to support children with Acute lymphoblastic leukaemia (ALL) undergoing chemotherapy is limited. Rehabilitation based on physiotherapy can enhance psychosocial well being and motor performances and aqua therapy has become a viable substitute. But no trials have currently evaluated the effectiveness of aqua therapy in this population.
Objective:
We aimed to evaluate the comparative efficacy of aqua-therapy versus conventional physiotherapy on motor function and psychosocial wellbeing in children with acute lymphoblastic leukaemia.
Methods:
A parallel, single-blinded (participant blinded), randomized control trial with embedded quantitative analysis will be completed. In total, 54 acute lymphoblastic leukaemia undergoing chemotherapy survivors will be recruited from an Acharya Vinoba Bhave Rural Hospital in Sawangi (Meghe), Wardha, Maharashtra, India. The experimental group will attend a 4-week, thrice-weekly, 45-minute aqua therapy session focusing on exercises-based rehabilitation. The comparison group will receive conventional physiotherapy including standardized exercise. Assessments will be completed at weeks 0 (baseline), 4 (post intervention), and 12 (follow-up). The primary outcome will be related to motor function measured using the Time Up and Go Test and the Paediatric Balance Scale at week 4. Secondary measures include psychosocial well being measured by The Hospital Anxiety and Depression Scale (HADS) and Functional abilities measured by The Functional Independence Measure (WeeFIM). Health service data including hospital length of stay, hospital readmissions, and emergency department presentations will be recorded. Semi structured interviews will be completed within an interpretive description framework to explore the patient’s description. The primary outcome will be analysed using linear mixed effects models
Results:
The trial has not yet commenced and will commence in May 2025
Conclusions:
The trial will inform the future implementation of rehabilitation for children with Acute Lymphoblastic Leukaemia by providing important data about efficacy of aqua therapy compared to conventional physiotherapy as well as patient experience. Clinical Trial: ICMR-National Institute of Medical Statistics Clinical Trial Registry- India CTRI/2025/03/083036
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