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

Not Applicable

Completed

• Conditions: Cerebral Palsy (CP)
• Interventions: Device: Galileo® tilt table for children

• Registration Number: NCT01491152
• Lead Sponsor: University of Cologne

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-12
• Study First Posted: 2011-12-13
• Study Start: 2012-01
• Status Verified: 2013-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
WBV Training	Galileo® tilt table for children	-

Primary Outcome Measures

Name	Time	Method
Change of gross motor function (GMFM-66)	Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

Secondary Outcome Measures

Name	Time	Method
Health-related quality of life (PedsQL)	Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Participation in activities in daily life (PEDI)	Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Passive Range of Motion (PROM)	Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Training compliance	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.

Trial Locations

Locations (1)

Children's Hospital University of Cologne; 🇩🇪 Cologne, Germany