Whole Body Vibration for Children and Young Adults With Moderate Severity of Cerebral Palsy

October 16, 2018 updated by: The Hong Kong Polytechnic University

Effect of Whole Body Vibration Therapy on Functional Abilities in Children and Young Adults With Moderate Severity of Cerebral Palsy- a Pilot Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hung Hom, Hong Kong
        • The Hong Kong Polytechnic University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Intervention arm
Whole body vibration will be provided by an equipment, GalileoTM Med L Plus (Novotech Medical GmbH). The study participant will stand still on the vibration platform with both knees slightly flexed.
Device: whole body vibration
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Gross Motor Function Measure (GMFM-66) item set
Time Frame: at 0 and 4 weeks
to assess changes in the gross motor function of study participants
at 0 and 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in 2-minute walk test (2MWT)
Time Frame: at 0 and 4 weeks
to assess changes in submaximal exercise capacity of the study participants by measuring the distance covered in 2 minutes using a distance-measuring trundle wheel
at 0 and 4 weeks
Changes in Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
Time Frame: at 0 and 4 weeks
to assess changes in the functional capacities in the domains of daily activities, mobility and social/cognitive function
at 0 and 4 weeks
Changes in Timed up and go test
Time Frame: at 0 and 4 weeks
to assess changes in the balance and functional mobility of the study participants by measuring the time used to perform this test
at 0 and 4 weeks
Parental/ participant questionnaire
Time Frame: at 4 weeks
to record satisfaction (0 means not satisfied and 10 as extreme satisfied) and any comments on the intervention regime as reported by the study participants and/or by their carers' proxy
at 4 weeks
Visual analogue scale
Time Frame: after each intervention session up to 4 weeks
to assess discomfort (0 means no discomfort and 10 as extreme discomfort), if any, associated with the intervention as reported by the study participants and/or by their carers' proxy
after each intervention session up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hong Kong Polytechnic University

Collaborators

Manchester Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 20, 2018

Primary Completion (ACTUAL)

September 28, 2018

Study Completion (ACTUAL)

September 28, 2018

Study Registration Dates

First Submitted

December 5, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 17, 2018

Last Update Submitted That Met QC Criteria

October 16, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YBW9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Anonymous individual and group data would be submitted for publication.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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