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

NCT ID: NCT01491152

Last Updated: 2014-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-02-28

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.

Conditions

Cerebral Palsy (CP)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

WBV Training

Group Type: EXPERIMENTAL

Galileo® tilt table for children

Intervention Type: DEVICE

Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)

Control

No WBV Training. Standard of Care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Galileo® tilt table for children

Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)

Intervention Type: DEVICE

Other Intervention Names

Novotec Medical, Pforzheim, Germany

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

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cologne

OTHER

Sponsor Role: lead

Responsible Party

Christina Stark

Staff member at the muscle-bone research group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Stark, MSc.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital University of Cologne

Peter Herkenrath, Dr.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital University of Cologne

Eckhard Schoenau, Prof.

Role: STUDY_CHAIR

Children's Hospital University of Cologne

Locations

Children's Hospital University of Cologne

Cologne, , Germany

Countries

Germany

Other Identifiers

Uni-Koeln-1527

Identifier Type: -

Identifier Source: org_study_id