Cerebral PalsyNCT03375736
Whole Body Vibration for Children and Young Adults With Moderate Severity of Cerebral Palsy
A study testing whole body vibration in people with Cerebral Palsy, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 45 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- whole body vibration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Feb 2018to 28 Sep 2018
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cerebral Palsy
- Being tested
- whole body vibration
- Keywords
- whole body vibration, cerebral palsy, functional abilities, children, adults
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
whole body vibrationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 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. Receives: Device: whole body vibration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Gross Motor Function Measure (GMFM-66) item set
to assess changes in the gross motor function of study participants
Measured: at 0 and 4 weeks
Secondary outcomes (5)
Changes in 2-minute walk test (2MWT)
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
Measured: at 0 and 4 weeks
Changes in Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
to assess changes in the functional capacities in the domains of daily activities, mobility and social/cognitive function
Measured: at 0 and 4 weeks
Changes in Timed up and go test
to assess changes in the balance and functional mobility of the study participants by measuring the time used to perform this test
Measured: at 0 and 4 weeks
Parental/ participant questionnaire
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
Measured: at 4 weeks
Visual analogue scale
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
Measured: after each intervention session up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start20 Feb 2018
- Primary completion28 Sep 2018
- Study completion28 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)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
- The study participants would receive 4 weeks of whole body vibration therapy, 4 sessions per week for 18 minutes per session.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Manchester Metropolitan University
- Responsible party
- Sponsor
- Investigators
- Tamis W Pin, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375736
- Sponsor's protocol ID
- YBW9
- Status last verified
- Nov 2017
- First submitted
- 5 Dec 2017
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Anonymous individual and group data would be submitted for publication.
Publications
Sheridan 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 19740209Rauch 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 26032205Houlihan CM, Stevenson RD. Bone density in cerebral palsy. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):493-508. doi: 10.1016/j.pmr.2009.04.004.
PubMed 19643349van 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 7562279Rosenbaum 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 18318732Mergler 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 19614941Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24.
PubMed 25461434Kilebrant S, Braathen G, Emilsson R, Glansen U, Soderpalm AC, Zetterlund B, Westerberg B, Magnusson P, Swolin-Eide D. Whole-body vibration therapy in children with severe motor disabilities. J Rehabil Med. 2015 Mar;47(3):223-8. doi: 10.2340/16501977-1921.
PubMed 25613047Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.
PubMed 23477461Ahlborg L, Andersson C, Julin P. Whole-body vibration training compared with resistance training: effect on spasticity, muscle strength and motor performance in adults with cerebral palsy. J Rehabil Med. 2006 Sep;38(5):302-8. doi: 10.1080/16501970600680262.
PubMed 16931460Dickin DC, Faust KA, Wang H, Frame J. The acute effects of whole-body vibration on gait parameters in adults with cerebral palsy. J Musculoskelet Neuronal Interact. 2013 Mar;13(1):19-26.
PubMed 23445911Gusso S, Munns CF, Colle P, Derraik JG, Biggs JB, Cutfield WS, Hofman PL. Effects of whole-body vibration training on physical function, bone and muscle mass in adolescents and young adults with cerebral palsy. Sci Rep. 2016 Mar 3;6:22518. doi: 10.1038/srep22518.
PubMed 26936535Russell DJ, Avery LM, Walter SD, Hanna SE, Bartlett DJ, Rosenbaum PL, Palisano RJ, Gorter JW. Development and validation of item sets to improve efficiency of administration of the 66-item Gross Motor Function Measure in children with cerebral palsy. Dev Med Child Neurol. 2010 Feb;52(2):e48-54. doi: 10.1111/j.1469-8749.2009.03481.x. Epub 2009 Oct 7.
PubMed 19811516
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03375736
- Acronym / sponsor ID
- YBW9
- Conditions
- Cerebral Palsy
- Keywords
- whole body vibration, cerebral palsy, functional abilities, children, adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Manchester Metropolitan University
- Study start
- 20 Feb 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 28 Sep 2018 (actual)
- First posted
- 18 Dec 2017 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study participants would receive 4 weeks of whole body vibration therapy, 4 sessions per week for 18 minutes per session.
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Device: whole body vibrationWhole 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. |
Who may qualify
- Ages
- 6 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 vibrationThe 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. | Device | Intervention arm |
Primary outcome
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
5 secondary outcomes
Changes in 2-minute walk test (2MWT)
Time frame: at 0 and 4 weeks
Changes in Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)
Time frame: at 0 and 4 weeks
Changes in Timed up and go test
Time frame: at 0 and 4 weeks
Parental/ participant questionnaire
Time frame: at 4 weeks
Visual analogue scale
Time frame: after each intervention session up to 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 Oct 2018.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 19643349Houlihan CM, Stevenson RD. Bone density in cerebral palsy. Phys Med Rehabil Clin N Am. 2009 Aug;20(3):493-508. doi: 10.1016/j.pmr.2009.04.004.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 25461434Cheng HY, Ju YY, Chen CL, Chuang LL, Cheng CH. Effects of whole body vibration on spasticity and lower extremity function in children with cerebral palsy. Hum Mov Sci. 2015 Feb;39:65-72. doi: 10.1016/j.humov.2014.11.003. Epub 2014 Nov 24.
- Results publication: PubMed 25613047Kilebrant S, Braathen G, Emilsson R, Glansen U, Soderpalm AC, Zetterlund B, Westerberg B, Magnusson P, Swolin-Eide D. Whole-body vibration therapy in children with severe motor disabilities. J Rehabil Med. 2015 Mar;47(3):223-8. doi: 10.2340/16501977-1921.
- Results publication: PubMed 23477461Unger M, Jelsma J, Stark C. Effect of a trunk-targeted intervention using vibration on posture and gait in children with spastic type cerebral palsy: a randomized control trial. Dev Neurorehabil. 2013;16(2):79-88. doi: 10.3109/17518423.2012.715313.
- Results publication: PubMed 16931460Ahlborg L, Andersson C, Julin P. Whole-body vibration training compared with resistance training: effect on spasticity, muscle strength and motor performance in adults with cerebral palsy. J Rehabil Med. 2006 Sep;38(5):302-8. doi: 10.1080/16501970600680262.
- Individual participant dataSharing planned: No. Anonymous individual and group data would be submitted for publication.
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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 in people with Cerebral Palsy, 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 3 inclusion and 4 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 Oct 2018. 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?
Changes in Gross Motor Function Measure (GMFM-66) item set (time frame: at 0 and 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 NCT03375736, which also lists 19 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 Oct 2018.