Clinical Trials Logo

Clinical 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. 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03779308
Study type Interventional
Source The Hong Kong Polytechnic University
Contact
Status Completed
Phase N/A
Start date January 1, 2019
Completion date December 31, 2019

See also
  Status Clinical Trial Phase
Recruiting NCT05317234 - Genetic Predisposition in Cerebral Palsy N/A
Recruiting NCT05576948 - Natural History of Cerebral Palsy Prospective Study
Completed NCT04119063 - Evaluating Wearable Robotic Assistance on Gait Early Phase 1
Completed NCT03264339 - The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy N/A
Completed NCT05551364 - Usability and Effectiveness of the ATLAS2030 Exoskeleton in Children With Cerebral Palsy N/A
Completed NCT03902886 - Independent Walking Onset of Children With Cerebral Palsy
Recruiting NCT05571033 - Operant Conditioning of the Soleus Stretch Reflex in Adults With Cerebral Palsy N/A
Not yet recruiting NCT04081675 - Compliance in Children With Cerebral Palsy Supplied With AFOs
Completed NCT02167022 - Intense Physiotherapies to Improve Function in Young Children With Cerebral Palsy N/A
Completed NCT04012125 - The Effect of Flexible Thoracolumbar Brace on Scoliosis in Cerebral Palsy N/A
Enrolling by invitation NCT05619211 - Piloting Movement-to-Music With Arm-based Sprint-Intensity Interval Training Among Children With Physical Disabilities Phase 1
Completed NCT04489498 - Comparison of Somatometric Characteristics Between Cerebral Palsy and Normal Children, Cross-sectional, Multi Center Study
Completed NCT03677193 - Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy N/A
Recruiting NCT06450158 - Robot-assisted Training in Children With CP N/A
Completed NCT04093180 - Intensive Neurorehabilitation for Cerebral Palsy N/A
Completed NCT02909127 - The Pediatric Eating Assessment Tool
Not yet recruiting NCT06377982 - Human Umbilical Cord Blood Infusion in Patients With Cerebral Palsy Phase 1
Not yet recruiting NCT06007885 - Examining Capacity Building of Youth With Physical Disabilities to Pursue Participation Following the PREP Intervention. N/A
Not yet recruiting NCT03183427 - Corpus Callosum Size in Patients With Pineal Cyst N/A
Active, not recruiting NCT03078621 - Bone Marrow-Derived Stem Cell Transplantation for the Treatment of Cerebral Palsy Phase 1/Phase 2