Clinical trial NCT03375736: Whole Body Vibration for Children and Young Adults With Moderate Severity of Cerebral Palsy
Official title: Effect of Whole Body Vibration Therapy on Functional Abilities in Children and Young Adults With Moderate Severity of Cerebral Palsy- a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: whole body vibration
cerebral palsy
functional abilities
children
adults
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Manchester Metropolitan University
First posted: 2017-12-18
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study participants would receive 4 weeks of whole body vibration therapy, 4 sessions per week for 18 minutes per session.
Primary purpose: TREATMENT

Brief summary: 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. 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. 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, it is unknown if the effect of WBVT would be for this population group when compared with 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, it is unknown 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.

Detailed description: 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, it is unknown 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. It is also unknown 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.

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 changes in the 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 and remain the same for the rest of the 2 weeks.

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.

Eligibility criteria: Inclusion Criteria:

* with a diagnosis of cerebral palsy with Gross Motor Function Classification System, GMFCS level III or IV
* able to stand on a vibration platform independently or by holding rails on their own
* able to follow simple instructions

Exclusion Criteria:

* 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.
* behavioral problems that prevent them to follow simple instructions
* females who are pregnant
* any metal implant

Primary outcomes:
measure: Changes in Gross Motor Function Measure (GMFM-66) item set
timeFrame: at 0 and 4 weeks
Secondary outcomes:
measure: Changes in 2-minute walk test (2MWT)
timeFrame: at 0 and 4 weeks
measure: Changes in Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
timeFrame: at 0 and 4 weeks
measure: Changes in Timed up and go test
timeFrame: at 0 and 4 weeks
measure: Parental/ participant questionnaire
timeFrame: at 4 weeks
measure: Visual analogue scale
timeFrame: after each intervention session up to 4 weeks
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Tamis W Pin, PhD
role: PRINCIPAL_INVESTIGATOR
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