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

Primary Purpose

Cerebral Palsy (CP)

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Galileo® tilt table for children
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy (CP) focused on measuring Cerebral Palsy, Whole Body Vibration, Infant, Motor development, Physiotherapy

Eligibility Criteria

12 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital University of Cologne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

WBV Training

Control

Arm Description

No WBV Training. Standard of Care.

Outcomes

Primary Outcome Measures

Change of gross motor function (GMFM-66)

Secondary Outcome Measures

Participation in activities in daily life (PEDI)
Health-related quality of life (PedsQL)
Passive Range of Motion (PROM)
Training compliance
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.

Full Information

First Posted
December 9, 2011
Last Updated
March 6, 2014
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01491152
Brief Title
Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
Official Title
Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy (CP)
Keywords
Cerebral Palsy, Whole Body Vibration, Infant, Motor development, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WBV Training
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Description
No WBV Training. Standard of Care.
Intervention Type
Device
Intervention Name(s)
Galileo® tilt table for children
Other Intervention Name(s)
Novotec Medical, Pforzheim, Germany
Intervention Description
Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Participation in activities in daily life (PEDI)
Time Frame
Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Title
Health-related quality of life (PedsQL)
Time Frame
Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Title
Passive Range of Motion (PROM)
Time Frame
Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Title
Training compliance
Description
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.
Time Frame
Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Stark, MSc.
Organizational Affiliation
Children's Hospital University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Herkenrath, Dr.
Organizational Affiliation
Children's Hospital University of Cologne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eckhard Schoenau, Prof.
Organizational Affiliation
Children's Hospital University of Cologne
Official's Role
Study Chair
Facility Information:
Facility Name
Children's Hospital University of Cologne
City
Cologne
Country
Germany

12. IPD Sharing Statement

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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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