None listed
Conditions
Brief summary
Cerebral palsy (CP) is the most common disability in childhood. CP is characterized by impaired mobility, low muscle mass, low bone density, and increased muscle tone. Therefore, one of the major focus of therapy in children with CP lies in increasing muscle mass, decreasing spasticity and, consequently, improving mobility, weight bearing and bone health. Despite the fact that children with CP have a number of therapeutic and surgical options to improve health and motor function, there is a void in interventions with a comprehensive effect on mobility, muscle mass and function, and bone strength. Vibration therapy (VT) has the potential to fill this therapeutic void. A recent extensive study on adolescents has shown a positive effect of vibration therapy on mobility, balance, and bone and muscle health in this age group. We anticipate that children between 2 and 4 years old will benefit even more, as these children are rapidly growing and developing. However, there have been no extensive studies on this age group with a rigorous research design and assessment. This study will address this issue, by assessing the feasibility of implementing VT as an early intervention on children with cerebral palsy as early as 2 years old.
Interventions
Control period. Before the intervention period, each participant will undergo 12 weeks of the control period. During the control period, participants will continue their usual activity levels and standard care.
Intervention period (12 weeks). Vibration therapy (VT) will be performed using the Galileo Basic vibration plates (Novotec Medical, Pforzheim, Germany). Each session will last 18 min: 3 min vibration followed by 3 minutes rest- repeated 3 times. Sessions will be performed 4 times a week,
Control period. Before the intervention period, each participant will undergo 12 weeks of the control period. During the control period, participants will continue their usual activity levels and standard care. Intervention period (12 weeks). Vibration therapy (VT) will be performed using the Galileo Basic vibration plates (Novotec Medical, Pforzheim, Germany). Each session will last 18 min: 3 min vibration followed by 3 minutes rest- repeated 3 times. Sessions will be performed 4 times a week, over 12- week period. Participants will start with sessions of three 1-minute bouts at 12 Hz, and both intensity and duration will be gradually increased according to the response of each individual. By the end of week 4, all participants should be training at the prescribed protocol of 3 sets of 3 minutes at intensity 20Hz. Training intensity will be maintained at 20Hz for the remainder of the intervention. Participants will stand barefoot on the plate with the knee slightly bent. An adjustable metal frame will be used for participants with poor balance for safely. Parents also will be trained to support children during the training sessions. Training sessions will be performed at home. An experienced exercise physiologist from the research team will supervise the participants performing training at home once a week in order to monitor progress and provide feedback/support. Parents/caregivers will provide ongoing supervision of home sessions.
Sponsors
Prof Paul Hofman
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
2 Years to 4 Years
Healthy volunteers
No
Inclusion criteria
- Have diagnosed cerebral palsy or indication of having cerebral palsy as per neurologist report GMFCS I – III - Be able to safely stand on the vibration platform - Be able to understand researcher’s instructions and follow them
Exclusion criteria
- A bone fracture within 12 weeks of enrolment - Acute thrombosis, tendinitis, nephrolithiasis, discopathy or arthritis - History of clinically significant organic disease or findings on physical examination, which in the opinion of the Investigator would prevent the patient from completing the study. - History of using any of the following medications, regardless of dose, for at least 1 month, within 3 months of enrolment: anabolic agents, glucocorticoids (does not include inhaled glucocorticoids) or growth hormone. - History of botulinum toxin injection into lower limbs within 3 months of enrolment
Outcome results
None listed