NCT01491152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
19 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

March 7, 2014

Status Verified

September 1, 2013

Enrollment Period

2.1 years

First QC Date

December 9, 2011

Last Update Submit

March 6, 2014

Conditions

Cerebral Palsy (CP)

Keywords

Cerebral PalsyWhole Body VibrationInfantMotor developmentPhysiotherapy

Outcome Measures

Primary Outcomes (1)

  • Change of gross motor function (GMFM-66)

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

Secondary Outcomes (4)

  • Participation in activities in daily life (PEDI)

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

  • Health-related quality of life (PedsQL)

    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 Arms (2)

WBV Training

EXPERIMENTAL
Device: Galileo® tilt table for children

Control

NO INTERVENTION

No WBV Training. Standard of Care.

Interventions

Galileo® tilt table for childrenDEVICE

Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)

Also known as: Novotec Medical, Pforzheim, Germany
WBV Training

Eligibility Criteria

Age12 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital University of Cologne

Cologne, Germany

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Christina Stark, MSc.

    Children's Hospital University of Cologne

    PRINCIPAL INVESTIGATOR

  • Peter Herkenrath, Dr.

    Children's Hospital University of Cologne

    PRINCIPAL INVESTIGATOR

  • Eckhard Schoenau, Prof.

    Children's Hospital University of Cologne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff member at the muscle-bone research group

Study Record Dates

First Submitted

December 9, 2011

First Posted

December 13, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 7, 2014

Record last verified: 2013-09

Locations

DE(1)