Whole Body Vibration for Dystonia Cerebral Palsy

NCT03779308 | Completed

• 1 other identifier: G-YBPA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Dystonia

Keywords

whole body vibration therapy; cerebral palsy; dystonia; functional abilities; tone abnormalities

Outcome Measures

Primary Outcomes (1)

• Gross Motor Function Measure 66 Item Set (GMFM-66 IS)

  assess gross motor function of participants

  4 weeks

Secondary Outcomes (5)

• Two-minute walk test (2MWT)

  4 weeks

• Barry-Albright Dystonia Scale (BADS)

  4 weeks

• Timed up and go test

  4 weeks

• Edinburgh Visual Gait Score

  4 weeks

• Chinese version of the Pediatric Evaluation of Disability Inventory (PEDI)

  4 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: whole body vibration therapy

Interventions

whole body vibration therapy DEVICE

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.

Intervention

Eligibility Criteria

• Age: 6 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

Location

Related Publications (18)

• 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.

  PMID: 12465563 BACKGROUND

• 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.

  PMID: 19740209 BACKGROUND

• van 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.

  PMID: 7562279 BACKGROUND

• Mergler 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.

  PMID: 19614941 BACKGROUND

• Henderson 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.

  PMID: 15832545 BACKGROUND

• Henderson 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.

  PMID: 15973316 BACKGROUND

• Rauch F. Vibration therapy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:166-8. doi: 10.1111/j.1469-8749.2009.03418.x.

  PMID: 19740225 BACKGROUND

• Matute-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.

  PMID: 24388109 BACKGROUND

• Saquetto 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.

  PMID: 26032205 BACKGROUND

• Rosenbaum 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.

  PMID: 18318732 BACKGROUND

• Jethwa 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.

  PMID: 20540176 BACKGROUND

• Pin 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.

  PMID: 28637155 BACKGROUND

• Barry 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.

  PMID: 10400175 BACKGROUND

• Fosang 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.

  PMID: 14515937 BACKGROUND

• Chen 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.

  PMID: 19247548 BACKGROUND

• Williams EN, Carroll SG, Reddihough DS, Phillips BA, Galea MP. Investigation of the timed 'up & go' test in children. Dev Med Child Neurol. 2005 Aug;47(8):518-24. doi: 10.1017/s0012162205001027.

  PMID: 16108451 BACKGROUND

• Del Pilar Duque Orozco M, Abousamra O, Church C, Lennon N, Henley J, Rogers KJ, Sees JP, Connor J, Miller F. Reliability and validity of Edinburgh visual gait score as an evaluation tool for children with cerebral palsy. Gait Posture. 2016 Sep;49:14-18. doi: 10.1016/j.gaitpost.2016.06.017. Epub 2016 Jun 15.

  PMID: 27344448 BACKGROUND

• Gusso 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.

  PMID: 26936535 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Dystonia

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tamis W Pin, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before and after cohort study with sample size less than 20

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 19, 2018
• Study Start: January 1, 2019
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 17, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)