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

Cerebral Palsy (CP) Clinical Trial

Official title:

Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01491152
• Other study ID #: Uni-Koeln-1527
• Status: Completed
• Phase: N/A
• First received: December 9, 2011
• Last updated: March 6, 2014
• Start date: January 2012
• Est. completion date: February 2014

Study information

• Verified date: September 2013
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Months to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Cerebral Palsy (CP)

Intervention

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)

Locations

Country	Name	City	State
Germany	Children's Hospital University of Cologne	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of gross motor function (GMFM-66)		Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)	No
Secondary	Participation in activities in daily life (PEDI)		Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)	No
Secondary	Health-related quality of life (PedsQL)		Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)	No
Secondary	Passive Range of Motion (PROM)		Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)	No
Secondary	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)	Yes