None listed
Conditions
Brief summary
Cerebral palsy (CP) is the most common disability in childhood. CP is characterized by impaired mobility, which depends on muscle mass and spasticity. Therefore, one of the major focuses of therapy in CP children is to increase muscle mass and power, decrease spasticity and consequently improve mobility, weight bearing and bone health. Unfortunately, there is a void in therapeutic interventions aimed at increasing muscle mass and function, bone mass in CP children. Vibration therapy (VT) has the potential to fill this therapeutic gap. A recent extensive study using vibration therapy in adolescents with CP has shown improvements in mobility, bone strength, and muscle mass. We assume that younger children may benefit similar or even more due to their growth and development period. There is however sparse information regarding the use of vibration therapy in younger individuals with CP and robust study designs and assessments are required. This study aims to identify the benefits of VT in children with CP aged 5-12 years old and identify the best protocol of the VT for this age group.
Interventions
Participants will perform vibration therapy 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 20- week periods. Each intervention group will have their own target intensity: either 20 or 25 Hz.
Training sessions will be performed at home or at school. An exercise physiologist from the research team will supervise the particip
Participants will perform vibration therapy 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 20- week periods. Each intervention group will have their own target intensity: either 20 or 25 Hz. Training sessions will be performed at home or at school. An exercise physiologist from the research team will supervise the participants performing training at home once a week and all 4 days of the week for those doing it at school, 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
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
- Have diagnosed cerebral palsy with GMFCS I - III - Be able to safely stand on the vibration platform - Be able to understand the 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 enrollment
Outcome results
None listed