Clinical trial NCT01491152: Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
Official title: Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy (CP)
Keywords: Cerebral Palsy
Whole Body Vibration
Infant
Motor development
Physiotherapy
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2011-12-13
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of gross motor function (GMFM-66)
timeFrame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Secondary outcomes:
measure: Participation in activities in daily life (PEDI)
timeFrame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
measure: Health-related quality of life (PedsQL)
timeFrame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
measure: Passive Range of Motion (PROM)
timeFrame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
measure: Training compliance
timeFrame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: Children's Hospital University of Cologne
Study officials:
affiliation: Children's Hospital University of Cologne
name: Christina Stark, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital University of Cologne
name: Peter Herkenrath, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital University of Cologne
name: Eckhard Schoenau, Prof.
role: STUDY_CHAIR
References: