Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
|ClinicalTrials.gov Identifier: NCT01491152|
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : March 7, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy (CP)||Device: Galileo® tilt table for children||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
|Experimental: WBV Training||
Device: Galileo® tilt table for children
Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)
Other Name: Novotec Medical, Pforzheim, Germany
No Intervention: Control
No WBV Training. Standard of Care.
- Change of gross motor function (GMFM-66) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
- Participation in activities in daily life (PEDI) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
- Health-related quality of life (PedsQL) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
- Passive Range of Motion (PROM) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
- Training compliance [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]Training compliance will be evaluated by the number of completed training units during the 14-week training period at home. Each training session will be documented in the patient diary (training protocol). Additionally the Galileo® WBV system will automatically record all training sessions performed on the device as date, time and duration of training session.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491152
|Children's Hospital University of Cologne|
|Principal Investigator:||Christina Stark, MSc.||Children's Hospital University of Cologne|
|Principal Investigator:||Peter Herkenrath, Dr.||Children's Hospital University of Cologne|
|Study Chair:||Eckhard Schoenau, Prof.||Children's Hospital University of Cologne|