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

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ClinicalTrials.gov Identifier: NCT01491152
Recruitment Status : Completed
First Posted : December 13, 2011
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease Intervention/treatment
Cerebral Palsy (CP) Device: Galileo® tilt table for children

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
Study Start Date : January 2012
Primary Completion Date : February 2014
Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Novotec Medical, Pforzheim, Germany
No Intervention: Control
No WBV Training. Standard of Care.


Outcome Measures

Primary Outcome Measures :
  1. Change of gross motor function (GMFM-66) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]

Secondary Outcome Measures :
  1. Participation in activities in daily life (PEDI) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
  2. Health-related quality of life (PedsQL) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
  3. Passive Range of Motion (PROM) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ]
  4. 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.


Eligibility Criteria

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Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491152


Locations
Germany
Children's Hospital University of Cologne
Cologne, Germany
Sponsors and Collaborators
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
More Information

Responsible Party: Christina Stark, Staff member at the muscle-bone research group, University of Cologne
ClinicalTrials.gov Identifier: NCT01491152     History of Changes
Other Study ID Numbers: Uni-Koeln-1527
First Posted: December 13, 2011    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: September 2013

Keywords provided by Christina Stark, University of Cologne:
Cerebral Palsy
Whole Body Vibration
Infant
Motor development
Physiotherapy

Additional relevant MeSH terms:
Paralysis
Cerebral Palsy
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases