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Clinical Trials/NCT01491152
NCT01491152
Completed
Not Applicable

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

University of Cologne1 site in 1 country24 target enrollmentJanuary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy (CP)
Sponsor
University of Cologne
Enrollment
24
Locations
1
Primary Endpoint
Change of gross motor function (GMFM-66)
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
February 2014
Last Updated
12 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christina Stark

Staff member at the muscle-bone research group

University of Cologne

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

Outcomes

Primary Outcomes

Change of gross motor function (GMFM-66)

Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

Secondary Outcomes

  • 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))

Study Sites (1)

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