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Whole Body Vibration for Dystonia Cerebral Palsy (WBVT)

Primary Purpose

Cerebral Palsy, Dystonia

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
whole body vibration therapy
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring whole body vibration therapy, cerebral palsy, dystonia, functional abilities, tone abnormalities

Eligibility Criteria

6 Years - 45 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 6 to 17 years or 18 to 40 years
  • With a diagnosis of CP or similar phenotype of childhood onset disability
  • Presence of dystonia in their tone abnormalities
  • Able to stand for 3 minutes independently or with own hand support on rails
  • Able to follow simple instructions
  • Able to undertake clinical examination; and
  • With informed consent by the participant's parent/ guardian or participants if able

Exclusion Criteria:

  • 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 or themselves if able.
  • Females during pregnancy
  • Metal implants in their spine and/or lower limbs

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

The participants will receive whole body vibration therapy while standing with hand support on a vibration platform.

Outcomes

Primary Outcome Measures

Gross Motor Function Measure 66 Item Set (GMFM-66 IS)
assess gross motor function of participants

Secondary Outcome Measures

Two-minute walk test (2MWT)
assess submaximal exercise capacity of participants by measuring the self-chosen pace walking distance covered in 2 minutes
Barry-Albright Dystonia Scale (BADS)
assess the severity of dystonia in a scale of 0 (no dystonia) to 4 (severe dystonia more than 50% of the time and/or prevent normal daily function). The grading will be done according to the published guidelines.Total score will be used as reported results for all the participants.
Timed up and go test
assess balance and functional mobility. The duration of the participant to complete the test task in terms of seconds will be used.
Edinburgh Visual Gait Score
assess any changes in the walking pattern in terms of 17 gait parameters in a scale of 0 (normal) to 2 (marked deviation from normal) according to the published guidelines. Total score will be used as reported results for all the participants.
Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
assess functional capacities in the domains of daily activities, mobility and social/cognitive function. The raw scores of each domain will be used for analyses.

Full Information

First Posted
December 17, 2018
Last Updated
February 13, 2020
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT03779308
Brief Title
Whole Body Vibration for Dystonia Cerebral Palsy
Acronym
WBVT
Official Title
Effect of Whole Body Vibration Therapy on Tone Abnormalities and Functional Abilities in Individuals With Dystonia Cerebral Palsy- a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Health bones allow us to move and walk freely without pain. Physical activities have been shown to relate to healthy bone growth. Children with physical disabilities are not able to do the same amount of exercises as their healthy peers. They are vulnerable to poor bone health, bone pain, and at high risk of osteopenia or even broken bones. This problem will extend to their adulthood. Recently, whole body vibration therapy (WBVT) has been proven to improve bone health and muscle function in healthy adults and post-menopausal women. Promising results have been shown on gross motor skills, balance and muscle strength for children and young adults with mild cerebral palsy (CP). Most of the vibration protocols require the participants perform some simple exercises on the vibration platform. Very limited studies have been done on children and young adults with moderate CP and almost none solely on individuals with dystonia CP. We do not know if the effect of the WBVT on individuals with dystonia CP would be the same as those with spastic CP and on those with moderate CP as those with mild CP. We also do not know if static standing on the vibration platform would have similar effects on tone abnormalities, balance and gross motor skills as doing simple exercises on the vibration platform because children and young adults with dystonia CP may not be able to freely do simple exercises on the vibration platform without extra support. The present pilot study is to systematically investigate the effects of WBVT on tone abnormalities, balance and functional abilities in children and young adults with dystonia CP.
Detailed Description
Muscle contractions during normal movements and regular exercises are believed to build strong bones or good bone health. Children with cerebral palsy (CP), especially those with moderate severity, 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 children with moderate to severe CP. This problem extends to their adulthood, causing osteopenia or osteoporosis. Whole body vibration therapy (WBVT) has been recently proven to improve bone health and muscle function in healthy adults, post-menopausal women and individuals with mild to moderate severity of CP. 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 moderate severity of CP, who have limited control in their body movements 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. Most of the studies, which yielded positive results, required the study participants to perform simple exercises on the vibration platform as the intervention. Very limited studies have been conducted on children and young adults with moderate severity of CP and almost no study solely on individuals with dystonia CP. Other than this lack of knowledge on this sub-group of CP, there are other knowledge gaps of this potential intervention to improve bone health for individuals with CP. Firstly, we do not know if the effect of WBVT on this population group would be similar or more effective than those with mild CP in terms of their tone abnormalities, gross motor function and balance, because the moderate group is greatly compromised in their mobility and extent of regular exercises when compared with those with mild CP. Secondly, preliminary results of the WBVT are promising in children and young adults with moderate severity of spastic CP. However, we do not know if these promising effects will be similar to those with dystonia or spastic dystonia CP because the vast differences in their tone and movement patterns. This pilot study aims to fill in these knowledge gaps and examine the effect of WBVT on children and young adults with moderate severity of dystonia CP in terms of muscle tone, balance and functional motor abilities. Methods A convenience sample of 5 children and adolescents aged between 6 to 17 years and 5 young adults aged between 18 to 45 years with dystonia or spastic dystonia CP will be recruited. As this is a pilot study, we recruit mild to moderate severity of CP, i.e. Gross Motor Function Classification System (GMFCS) levels I to IV. In general, individuals of levels I and II ambulate unaided and are able to perform more advanced motor skills such as running and jumping with limitations. Individuals of 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. Individuals with level V are non-ambulatory or totally rely on wheeled mobility aids in all environment settings. The presence of dystonia in the recruited participants will be firstly confirmed using the Hypertonia Assessment Tool (HAT). It is a reliable and valid clinical tool to confirm the presence of dystonia in individuals with CP. Only those confirmed with dystonia or spastic dystonia CP will be included in this study. Assessments will be performed at baseline and at completion of the intervention to examine the functional abilities of the study participants. The study participants will receive the WBVT when standing still on a vibration platform independently or with own hand support on the platform rail. The vibration protocol is modified from the study by Gusso et al (2016) and has also been tested in a pilot study by PI on a group of children, adolescents and young adults with spastic CP. The WBVT training is of 20 Hertz, a peak-to-peak amplitude of 2 mm and peak acceleration of 15.79m/s or 1.61g. The sessions will be 18 minutes in length, 4 days per week for 4 weeks. The vibration frequency, duration and amplitude will be progressively increased over 2 weeks to the desired parameters. The study results will be presented as means and standard deviations. Due to the small sample size, non-parametric Wilcoxon Signed Ranks test will be used to compare the results before and after the WBVT. The statistical significance level is set at p< 0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Dystonia
Keywords
whole body vibration therapy, cerebral palsy, dystonia, functional abilities, tone abnormalities

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Before and after cohort study with sample size less than 20
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
The participants will receive whole body vibration therapy while standing with hand support on a vibration platform.
Intervention Type
Device
Intervention Name(s)
whole body vibration therapy
Intervention Description
The study participants will receive the WBVT when standing still on a vibration platform independently or with own hand support on the platform rail. The vibration protocol is modified from the study by Gusso et al (2016). The WBVT training is of 20 Hertz, a peak-to-peak amplitude of 2 mm and peak acceleration of 15.79m/s or 1.61g. The sessions will be 18 minutes in length, 4 days per week for 4 weeks. The vibration frequency, duration and amplitude will be progressively increased over 2 weeks to the desired parameters.
Primary Outcome Measure Information:
Title
Gross Motor Function Measure 66 Item Set (GMFM-66 IS)
Description
assess gross motor function of participants
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Two-minute walk test (2MWT)
Description
assess submaximal exercise capacity of participants by measuring the self-chosen pace walking distance covered in 2 minutes
Time Frame
4 weeks
Title
Barry-Albright Dystonia Scale (BADS)
Description
assess the severity of dystonia in a scale of 0 (no dystonia) to 4 (severe dystonia more than 50% of the time and/or prevent normal daily function). The grading will be done according to the published guidelines.Total score will be used as reported results for all the participants.
Time Frame
4 weeks
Title
Timed up and go test
Description
assess balance and functional mobility. The duration of the participant to complete the test task in terms of seconds will be used.
Time Frame
4 weeks
Title
Edinburgh Visual Gait Score
Description
assess any changes in the walking pattern in terms of 17 gait parameters in a scale of 0 (normal) to 2 (marked deviation from normal) according to the published guidelines. Total score will be used as reported results for all the participants.
Time Frame
4 weeks
Title
Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
Description
assess functional capacities in the domains of daily activities, mobility and social/cognitive function. The raw scores of each domain will be used for analyses.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 6 to 17 years or 18 to 40 years With a diagnosis of CP or similar phenotype of childhood onset disability Presence of dystonia in their tone abnormalities Able to stand for 3 minutes independently or with own hand support on rails Able to follow simple instructions Able to undertake clinical examination; and With informed consent by the participant's parent/ guardian or participants if able Exclusion Criteria: 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 or themselves if able. Females during pregnancy Metal implants in their spine and/or lower limbs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tamis W Pin, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hung Hom
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No
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Whole Body Vibration for Dystonia Cerebral Palsy

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