Cerebral PalsyWBVTNCT03779308
Whole Body Vibration for Dystonia Cerebral Palsy
A study testing whole body vibration therapy in people with Cerebral Palsy and Dystonia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Cerebral Palsy, Dystonia
- What is being tested?
- whole body vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whole Body Vibration Therapy on Tone Abnormalities and Functional Abilities in Individuals With Dystonia Cerebral Palsy- a Pilot Study
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.
Read more
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.
Read the 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.
- Conditions
- Cerebral Palsy, Dystonia
- Being tested
- whole body vibration therapy
- Keywords
- whole body vibration therapy, cerebral palsy, dystonia, functional abilities, tone abnormalities
- Medical subject headings
- Cerebral Palsy, Dystonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibration therapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The participants will receive whole body vibration therapy while standing with hand support on a vibration platform. Receives: Device: whole body vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gross Motor Function Measure 66 Item Set (GMFM-66 IS)
assess gross motor function of participants
Measured: 4 weeks
Secondary outcomes (5)
Two-minute walk test (2MWT)
assess submaximal exercise capacity of participants by measuring the self-chosen pace walking distance covered in 2 minutes
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Jan 2019
- Primary completion30 Oct 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after cohort study with sample size less than 20
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tamis W Pin, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779308
- Sponsor's protocol ID
- G-YBPA
- Acronym
- WBVT
- Status last verified
- Feb 2020
- First submitted
- 17 Dec 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Apkon SD. Osteoporosis in children who have disabilities. Phys Med Rehabil Clin N Am. 2002 Nov;13(4):839-55. doi: 10.1016/s1047-9651(02)00026-8.
PubMed 12465563Sheridan KJ. Osteoporosis in adults with cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:38-51. doi: 10.1111/j.1469-8749.2009.03432.x.
PubMed 19740209van den Berg-Emons HJ, Saris WH, de Barbanson DC, Westerterp KR, Huson A, van Baak MA. Daily physical activity of schoolchildren with spastic diplegia and of healthy control subjects. J Pediatr. 1995 Oct;127(4):578-84. doi: 10.1016/s0022-3476(95)70115-x.
PubMed 7562279Mergler S, Evenhuis HM, Boot AM, De Man SA, Bindels-De Heus KG, Huijbers WA, Penning C. Epidemiology of low bone mineral density and fractures in children with severe cerebral palsy: a systematic review. Dev Med Child Neurol. 2009 Oct;51(10):773-8. doi: 10.1111/j.1469-8749.2009.03384.x. Epub 2009 Jul 8.
PubMed 19614941Henderson RC, Gilbert SR, Clement ME, Abbas A, Worley G, Stevenson RD. Altered skeletal maturation in moderate to severe cerebral palsy. Dev Med Child Neurol. 2005 Apr;47(4):229-36. doi: 10.1017/s0012162205000459.
PubMed 15832545Henderson RC, Kairalla JA, Barrington JW, Abbas A, Stevenson RD. Longitudinal changes in bone density in children and adolescents with moderate to severe cerebral palsy. J Pediatr. 2005 Jun;146(6):769-75. doi: 10.1016/j.jpeds.2005.02.024.
PubMed 15973316Rauch F. Vibration therapy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:166-8. doi: 10.1111/j.1469-8749.2009.03418.x.
PubMed 19740225Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.
PubMed 24388109Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.
PubMed 26032205Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
PubMed 18318732Jethwa A, Mink J, Macarthur C, Knights S, Fehlings T, Fehlings D. Development of the Hypertonia Assessment Tool (HAT): a discriminative tool for hypertonia in children. Dev Med Child Neurol. 2010 May;52(5):e83-7. doi: 10.1111/j.1469-8749.2009.03483.x.
PubMed 20540176Pin TW, Choi HL. Reliability, validity, and norms of the 2-min walk test in children with and without neuromuscular disorders aged 6-12. Disabil Rehabil. 2018 Jun;40(11):1266-1272. doi: 10.1080/09638288.2017.1294208. Epub 2017 Mar 3.
PubMed 28637155Barry MJ, VanSwearingen JM, Albright AL. Reliability and responsiveness of the Barry-Albright Dystonia Scale. Dev Med Child Neurol. 1999 Jun;41(6):404-11. doi: 10.1017/s0012162299000870.
PubMed 10400175Fosang AL, Galea MP, McCoy AT, Reddihough DS, Story I. Measures of muscle and joint performance in the lower limb of children with cerebral palsy. Dev Med Child Neurol. 2003 Oct;45(10):664-70. doi: 10.1017/s0012162203001245.
PubMed 14515937Chen KL, Hsieh CL, Sheu CF, Hu FC, Tseng MH. Reliability and validity of a Chinese version of the Pediatric Evaluation of Disability Inventory in children with cerebral palsy. J Rehabil Med. 2009 Mar;41(4):273-8. doi: 10.2340/16501977-0319.
PubMed 19247548
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole Body Vibration Therapy on Tone Abnormalities and Functional Abilities in Individuals With Dystonia Cerebral Palsy- a Pilot Study
- ClinicalTrials.gov ID
- NCT03779308
- Acronym / sponsor ID
- WBVT / G-YBPA
- Conditions
- Cerebral Palsy, Dystonia
- Keywords
- whole body vibration therapy, cerebral palsy, dystonia, functional abilities, tone abnormalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after cohort study with sample size less than 20
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: whole body vibration therapyThe participants will receive whole body vibration therapy while standing with hand support on a vibration platform. |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| whole body vibration therapyThe 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. | Device | Intervention |
Primary outcome
Gross Motor Function Measure 66 Item Set (GMFM-66 IS)
Time frame: 4 weeks
assess gross motor function of participants
5 secondary outcomes
Two-minute walk test (2MWT)
Time frame: 4 weeks
Barry-Albright Dystonia Scale (BADS)
Time frame: 4 weeks
Timed up and go test
Time frame: 4 weeks
Edinburgh Visual Gait Score
Time frame: 4 weeks
Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 12465563Apkon SD. Osteoporosis in children who have disabilities. Phys Med Rehabil Clin N Am. 2002 Nov;13(4):839-55. doi: 10.1016/s1047-9651(02)00026-8.
- Background: PubMed 19740209Sheridan KJ. Osteoporosis in adults with cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:38-51. doi: 10.1111/j.1469-8749.2009.03432.x.
- Background: PubMed 7562279van den Berg-Emons HJ, Saris WH, de Barbanson DC, Westerterp KR, Huson A, van Baak MA. Daily physical activity of schoolchildren with spastic diplegia and of healthy control subjects. J Pediatr. 1995 Oct;127(4):578-84. doi: 10.1016/s0022-3476(95)70115-x.
- Background: PubMed 19614941Mergler S, Evenhuis HM, Boot AM, De Man SA, Bindels-De Heus KG, Huijbers WA, Penning C. Epidemiology of low bone mineral density and fractures in children with severe cerebral palsy: a systematic review. Dev Med Child Neurol. 2009 Oct;51(10):773-8. doi: 10.1111/j.1469-8749.2009.03384.x. Epub 2009 Jul 8.
- Background: PubMed 15832545Henderson RC, Gilbert SR, Clement ME, Abbas A, Worley G, Stevenson RD. Altered skeletal maturation in moderate to severe cerebral palsy. Dev Med Child Neurol. 2005 Apr;47(4):229-36. doi: 10.1017/s0012162205000459.
- Background: PubMed 15973316Henderson RC, Kairalla JA, Barrington JW, Abbas A, Stevenson RD. Longitudinal changes in bone density in children and adolescents with moderate to severe cerebral palsy. J Pediatr. 2005 Jun;146(6):769-75. doi: 10.1016/j.jpeds.2005.02.024.
- Background: PubMed 19740225Rauch F. Vibration therapy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:166-8. doi: 10.1111/j.1469-8749.2009.03418.x.
- Background: PubMed 24388109Matute-Llorente A, Gonzalez-Aguero A, Gomez-Cabello A, Vicente-Rodriguez G, Casajus Mallen JA. Effect of whole-body vibration therapy on health-related physical fitness in children and adolescents with disabilities: a systematic review. J Adolesc Health. 2014 Apr;54(4):385-96. doi: 10.1016/j.jadohealth.2013.11.001. Epub 2014 Jan 1.
- Background: PubMed 26032205Saquetto M, Carvalho V, Silva C, Conceicao C, Gomes-Neto M. The effects of whole body vibration on mobility and balance in children with cerebral palsy: a systematic review with meta-analysis. J Musculoskelet Neuronal Interact. 2015 Jun;15(2):137-44.
- Background: PubMed 18318732Rosenbaum PL, Palisano RJ, Bartlett DJ, Galuppi BE, Russell DJ. Development of the Gross Motor Function Classification System for cerebral palsy. Dev Med Child Neurol. 2008 Apr;50(4):249-53. doi: 10.1111/j.1469-8749.2008.02045.x. Epub 2008 Mar 1.
- Background: PubMed 20540176Jethwa A, Mink J, Macarthur C, Knights S, Fehlings T, Fehlings D. Development of the Hypertonia Assessment Tool (HAT): a discriminative tool for hypertonia in children. Dev Med Child Neurol. 2010 May;52(5):e83-7. doi: 10.1111/j.1469-8749.2009.03483.x.
- Background: PubMed 28637155Pin TW, Choi HL. Reliability, validity, and norms of the 2-min walk test in children with and without neuromuscular disorders aged 6-12. Disabil Rehabil. 2018 Jun;40(11):1266-1272. doi: 10.1080/09638288.2017.1294208. Epub 2017 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tamis W Pin, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing whole body vibration therapy in people with Cerebral Palsy and Dystonia, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gross Motor Function Measure 66 Item Set (GMFM-66 IS) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03779308, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.