BMJ open · 2026
Effects of whole-body vibration therapy on motor function, muscle tone, balance, walking endurance and quality of life in children with cerebral palsy: study protocol for a randomised controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Wang Yajie, Wang Tao, Jin Beiyi, Chen Yuxi, Li Hongpeng, Chai Siaw Chui, Zanudin Asfarina
Аннотация
INTRODUCTION: Cerebral palsy (CP) is a neurodevelopmental disorder characterised by permanent motor impairments that substantially affect functional performance and quality of life. Whole-body vibration therapy (WBVT) has shown potential benefits for improving motor outcomes in children with CP; however, current evidence remains limited by small sample sizes and heterogeneous intervention protocols. This study aims to evaluate the effects of WBVT as an adjunct to conventional rehabilitation in children with CP.
METHODS AND ANALYSIS: A single-centre, two-arm randomised controlled trial will be conducted with 40 children aged 6-17 years with CP, including children with spastic hemiplegia, spastic diplegia and ataxic CP classified as Gross Motor Function Classification System levels I-III. Participants will be randomised (1:1) to receive either WBVT plus conventional rehabilitation or conventional rehabilitation alone for 12 weeks. The primary outcome is the Gross Motor Function Measure 88 total score. Secondary outcomes include the Modified Ashworth Scale, the Pediatric Balance Scale, the Timed Up and Go, the 6-minute walk test, the 10-metre walk test and the Pediatric Quality of Life Inventory, measured at baseline, week 6 and week 12. Data will be analysed using repeated-measures analysis of variance.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Review Committee of Lanzhou Disabled Persons Care, Employment and Rehabilitation Center (LZTK-2025-0711-01) and the Universiti Kebangsaan Malaysia Research Ethics Committee (JEP-2025-625). Written informed consent will be obtained from parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2500112839.
METHODS AND ANALYSIS: A single-centre, two-arm randomised controlled trial will be conducted with 40 children aged 6-17 years with CP, including children with spastic hemiplegia, spastic diplegia and ataxic CP classified as Gross Motor Function Classification System levels I-III. Participants will be randomised (1:1) to receive either WBVT plus conventional rehabilitation or conventional rehabilitation alone for 12 weeks. The primary outcome is the Gross Motor Function Measure 88 total score. Secondary outcomes include the Modified Ashworth Scale, the Pediatric Balance Scale, the Timed Up and Go, the 6-minute walk test, the 10-metre walk test and the Pediatric Quality of Life Inventory, measured at baseline, week 6 and week 12. Data will be analysed using repeated-measures analysis of variance.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Ethics Review Committee of Lanzhou Disabled Persons Care, Employment and Rehabilitation Center (LZTK-2025-0711-01) and the Universiti Kebangsaan Malaysia Research Ethics Committee (JEP-2025-625). Written informed consent will be obtained from parents or legal guardians prior to participation. Study findings will be disseminated through peer-reviewed publications and scientific conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2500112839.