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

March 6, 2014 updated by: Christina Stark, University of Cologne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Cologne, Germany
        • Children's Hospital University of Cologne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Novotec Medical, Pforzheim, Germany
No Intervention: Control
No WBV Training. Standard of Care.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participation in activities in daily life (PEDI)
Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
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)
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)
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.
Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cologne

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

December 9, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 13, 2011

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uni-Koeln-1527

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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