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
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
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
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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