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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christina Stark, University of Cologne
ClinicalTrials.gov Identifier:
NCT01491152
First received: December 9, 2011
Last updated: March 6, 2014
Last verified: September 2013
  Purpose

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 Intervention
Cerebral Palsy (CP)
Device: Galileo® tilt table for children

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Change of gross motor function (GMFM-66) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Participation in activities in daily life (PEDI) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ] [ Designated as safety issue: No ]
  • Health-related quality of life (PedsQL) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ] [ Designated as safety issue: No ]
  • Passive Range of Motion (PROM) [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ] [ Designated as safety issue: No ]
  • Training compliance [ Time Frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 24
Study Start Date: January 2012
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 9, 2011
Last Updated: March 6, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on August 20, 2014