Effect of Whole Body Vibration Therapy on Functional Abilities in Children and Young Adults With Moderate Severity of Cerebral Palsy- a Pilot Study
Phase: NA
Conditions: Cerebral Palsy
Sponsor: The Hong Kong Polytechnic University

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Effect of whole body vibration therapy on functional abilities in children and young adults with 
moderate severity of cerebral palsy- a pilot study  
 
The following pages include: 
1. Intervention protocol of the whole body vibration therapy to the study participants; and  
2. Statistical methods to analyze the results 
3. Ethics approval  
 
NCT number- NCT03375736 
Document was written on 22 November 2017. 
 
 

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Study proposal 
Project Title :  
 
 
Effect of whole body vibration therapy on functional abilities in children and 
young adults with moderate severity of cerebral palsy- a pilot study. 
Principal Investigators:  
 
Dr Tamis W Pin, Dr Penelope Butler, Ms Sheila Purves 
Project Objectives : 
Osteopenia is common in children with cerebral palsy (CP) due to poor bone growth and muscle disuse 
and the problem extends to their adulthood. These children and young adults with CP, especially those 
with moderate physical disabilities, are unable to perform the required amount of exercise to improve 
their bone health as their typically developing counterparts. It has been demonstrated that strong bones or 
good bone health are related to muscle contractions during normal movements and regular exercises. As a 
result, non-traumatic fractures and bone pain are common in individuals with moderate severity of CP. 
Whole body vibration therapy (WBVT) has been recently proven to improve bone health and muscle 
function in healthy adults and post-menopausal women. It has been postulated that the vibration can 
stimulate the muscle spindles and elicit consistent muscle contractions. This would be a great advantage 
to the individuals with physical disabilities, who have limited movements and control in their body and 
prevent them to perform regular exercises as the normal individuals. Among the research of the WBVT 
for children with CP, promising results have been shown on gross motor function, balance and muscle 
strength for children with mild disability. Among these published studies, the vibration protocols required 
the study participants to perform simple exercises on the vibration platform. Very limited studies have 
been conducted on children and young adults with moderate CP. At present, we do not know if the effect 
of WBVT on this population group would be similar to those with mild CP in terms of their gross motor 
function and balance, because the moderate group is greatly compromised in their mobility and extent of 
regular exercises when compared with the normal population and those with mild CP. In addition, we do 
not know if static standing on the vibration platform would have similar effects on the gross motor 
function as doing simple exercises on the vibration platform.  
 
This pilot study aims to examine the effect of WBVT on children and young adults with moderate 
severity of CP. A convenience sample of 5 pre-puberty children aged between 6 to 14 years and 5 young 
adults aged between 18 to 40 years with moderate CP, i.e. Gross Motor Function Classification System, 
GMFCS level III or IV, will be recruited to systematically investigate the effects of WBVT on their 
functional abilities. Individuals with GMFCS level III mobilise with hand-held mobility devices such as 
crutches or walking frames. Individuals of levels IV have very limited functional mobility and are mostly 
limited to an indoor environment.  
 
Inclusion criteria: 
1. Aged 6 to 14 years or 18 to 40 years 
2. Have a diagnosis of cerebral palsy with GMFCS levels III or IV 
3. Be able to stand for 3 minutes independently or with own hand support on rails 
4. Be able to follow simple instructions 
5. Be able to undertake clinical examination; and 
6. Informed consent by the participant’s parent/ guardian 
Exclusion criteria: 
1. There is a history of fracture within 8 weeks of enrolment of the present study and acute 
thrombosis, muscle or tendon inflammation, renal stones, discopathy or arthritis as reported by 
their parent/ guardian. 
2. Women during pregnancy 
3. Metal implants in their spine or lower limbs 
 
The children and young adults will receive the WBVT when standing still on a vibration platform of 20 
Hertz and a peak-to-peak amplitude of 2 mm: sessions will be 18 minutes in length, 4 days per week for 4 
weeks. Assessments will be performed at baseline and at completion of the intervention to examine the 

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functional abilities of these children and young adults. The vibration frequency, duration and amplitude 
will be progressively increased over 2 weeks to the maximum of 3 minutes of 20 Hz with a peak-to-peak 
amplitude of 2mm. The intervention regime is as follows: 
 
Day 
Vibration 1 
Rest 1 Vibration 2 
Rest 2 
Vibration 3 
Rest 3 
1st 
1 min; 12Hz, 1mm 
3 min 
1 min; 12Hz, 1mm 
3 min 
1 min; 15Hz, 1mm 
3 min 
2nd 
1 min; 15Hz, 1mm 
3 min 
1 min; 15Hz, 1mm 
3 min 
2 min; 15Hz, 1mm 
3 min 
3th 
2 min; 15Hz, 1mm 
3 min 
3 min; 15Hz, 1mm 
3 min 
3 min; 15Hz, 1mm 
3 min 
4th  
2 min; 18Hz, 1mm 
3 min 
2 min; 18Hz, 1mm 
3 min 
2 min; 18Hz, 1mm 
3 min 
5th 
3 min; 20Hz, 1mm 
3 min 
3 min; 20Hz, 1mm 
3 min 
3 min; 20Hz, 1mm 
3 min 
6th 
3 min; 20Hz, 1mm 
3 min 
3 min; 20Hz, 2mm 
3 min 
3 min; 20Hz, 2mm 
3 min 
>7th 
3 min; 20Hz, 2mm 
3 min 
3 min; 20Hz, 2mm 
3 min 
3 min; 20Hz, 2mm 
3 min 
 
The outcome measures comprise: 
1. Gross Motor Function Measure (GMFM-66) item set to assess the gross motor function of study 
participants. Raw scores will be reported. 
2. 2-minute walk test (2MWT) to assess submaximal exercise capacity of the study participants by 
measuring the distance covered in 2 minutes using a distance-measuring trundle wheel. 
3. A validated Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI) to assess 
functional capacities in the domains of daily activities, mobility and social/cognitive function. 
4. Timed up and go test to assess balance and functional mobility of the study participants  
5. Parental/ participant questionnaire to record satisfaction or comments on the intervention regime by 
children/ young adults/ parents of the intervention group.  
6. Visual analogue scale of 0 to 10, in which 0 means no discomfort and 10 as extreme discomfort to 
assess discomfort, if any, associated with the intervention as reported by the study participants and/or by 
their carers’ proxy 
 
Analysis of data/ statistics: 
Results will be presented as means, standard deviations and standard errors of measurement. Due to the 
present small sample size, non-parametric analyses would be conducted. Wilcoxon Sign test will be used 
to compare the outcome measures before and after the intervention for outcome measures #1 to #4 
mentioned above. The feedback from the participants and/or their parents would be summarized, if any. 
 
Significance of present proposal: 
If the WBVT is found to be effective in improving BMD and functional abilities at the conclusion of the 
present study, the participants in the control group would be offered the same intervention regime as the 
intervention group upon study completion.The outcomes of this pilot study will show if this intervention 
is beneficial for children and young adults with moderate CP with respect to their functional abilities, and 
if there may be any related practical issues of this intervention to this population group. The outcomes 
also provide preliminary evidence to clinicians if this intervention is effective to improve functional 
abilities of children and young adults with moderate severity of CP and provide preliminary data to 
calculate sample sizes for future studies.