Parent-delivered Hand-arm Bimanual Intensive Training Including Lower Extremity for young children with bilateral cerebral palsy in Vietnam: protocol for a randomised controlled trial.

Abstract

Cerebral palsy (CP) is a leading cause of long-term disability for children in Vietnam and across the world, affecting both gross and fine motor skills as well as daily independence. Intensive therapy has been shown to significantly improve motor outcomes. Moreover, parental involvement in therapy contributes positively to child development. Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE) is a structured intervention that targets motor function of the upper and lower extremities through intensive, goal-directed practice. This study aims to evaluate the effectiveness of a parent-delivered HABIT-ILE programme in young children with CP in Vietnam, using a randomised controlled trial comparing onsite and online groups of intervention. A total of 48 children aged 2-6 years diagnosed with bilateral CP will be randomly assigned to one of two intervention groups: parent-delivered HABIT-ILE conducted either in a rehabilitation centre or at home. Participants will be paired based on their age and functional levels using the Gross Motor Function Classification System Expanded and Revised and the (mini-)Manual Ability Classification System before randomisation. Each group will receive an identical 50-hour intervention over 2 weeks, delivered by parents under the supervision of HABIT-ILE experts. Primary outcomes include the Gross Motor Function Measure-66 and the Melbourne Assessment 2. Secondary outcomes will consist of Vietnamese versions of the West-African version of the ACTIVLIM-CP questionnaire, Paediatric Evaluation of Disability Inventory, Canadian Occupational Performance Measure and parental quality of life with World Health Organization Quality of Life Brief Version questionnaire. Assessments will occur twice at baseline with 2 weeks in between (T0 and T1), postintervention (T2, 2 weeks after T1) and 3-month follow-up (T3). A 2 (group)×4 (time) repeated-measures analysis of variance will be used to analyse the data ETHICS AND DISSEMINATION: The study has been approved by the Ethics Committee in Biomedical Research at the University of Medicine and Pharmacy at Ho Chi Minh City (Approval No. 726/HĐĐĐ-ĐHYD, issued on 13 June 2024). NCT06593158.