Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
This study is currently recruiting participants.
Verified June 2012 by University of Cologne
Sponsor:
University of Cologne
Information provided by (Responsible Party):
Christina Stark, University of Cologne
ClinicalTrials.gov Identifier:
NCT01491152
First received: December 9, 2011
Last updated: June 12, 2012
Last verified: June 2012
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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.
| Estimated Enrollment: | 24 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01491152
Contacts
| Contact: Christina Stark, MSc. | +49 221 478 ext 98464 | christina.stark@uk-koeln.de |
| Contact: Studienzentrum Paediatrie | 0221-478 ext 6831 | kinderklinik-studiensekretariat@uk-koeln.de |
Locations
| Germany | |
| Children's Hospital University of Cologne | Recruiting |
| Cologne, Germany | |
| Contact: Stark +49 478 christina.stark@uk-koeln.de | |
| Principal Investigator: Christina Stark, MSc. | |
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: | June 12, 2012 |
| 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 May 23, 2013