Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WBV Training | Experimental |
| |
| Control | No Intervention | No WBV Training. Standard of Care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galileo® tilt table for children | Device | Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of gross motor function (GMFM-66) | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Participation in activities in daily life (PEDI) | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | |
| Health-related quality of life (PedsQL) | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christina Stark, MSc. | Children's Hospital University of Cologne | Principal Investigator |
| Peter Herkenrath, Dr. | Children's Hospital University of Cologne | Principal Investigator |
| Eckhard Schoenau, Prof. | Children's Hospital University of Cologne | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital University of Cologne | Cologne | Germany |
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Passive Range of Motion (PROM) | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) |
| Training compliance | 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. | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) |