Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age

University of Cologne

Status: Completed

Conditions: Cerebral Palsy (CP)

Treatments: Device: Galileo® tilt table for children

Study type: Interventional

Funder types: Other

Identifiers

NCT01491152

Uni-Koeln-1527

Details and patient eligibility

About

Cerebral Palsy (CP) is the most common cause of physical disability in childhood. Up to day the investigators have treated children diagnosed cerebral palsy with side-alternating whole body vibration (System Galileo®) from the age of two years on. Considering verticalisation (standing and walking) at about 12 months of age in a normal developing child the investigators suggest the introduction of verticalisation with whole body vibration to a child with CP at this early age in order to enhance motor development and participation.

In this pilot study the investigators will test the feasibility and the effect on motor development of whole body vibration in children with CP from 12 months of age. The investigators will investigate the effect of whole body vibration on motor performance, independence in all day living situations, quality of life and contractures compared to a control group.

Enrollment: 24 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children diagnosed CP
• ≥ 12 months and ≤ 24 months of age (prematures corrected age)
• GMFCS level II, III, IV
• Inability to stand and walk
• Written informed consent of legal guardian

Exclusion criteria

• Chronic infectious disease
• Epilepsy not responding to therapy
• Additional severe congenital disorder (e.g. congenital heart disorder)
• Surgery in previous three months
• Hernia requiring surgery
• Treatment with Botulinumtoxin
• Acute Thromboses
• Implants and tendinitis in body parts to be trained
• Acute inflammation in the musculoskeletal system
• Slipped disc
• Rheumatoid arthritis
• Fractures in previous three months
• Intracerebral bleeding in previous three months
• Planned surgery in study period
• Participation at another interventional trial
• Gall stones, kidney stones and pregnancy of the person who trains with the child

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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24 participants in 2 patient groups

WBV Training

Experimental group

Treatment:

Device: Galileo® tilt table for children

Control

No Intervention group

Description:

No WBV Training. Standard of Care.