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

Study Overview
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Brief Summary
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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.

Official Title
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Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study

Conditions
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Cerebral Palsy (CP)

Intervention / Treatment
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* Device: Galileo® tilt table for children


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WBV Training<br> | Device: Galileo® tilt table for children<br>* Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)<br>* Other names: Novotec Medical, Pforzheim, Germany;|
| No Intervention: Control<br>No WBV Training. Standard of Care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of gross motor function (GMFM-66) |  | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation in activities in daily life (PEDI) |  | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | 
| Health-related quality of life (PedsQL) |  | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | 
| Passive Range of Motion (PROM) |  | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | 
| 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. | Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cerebral Palsy, Whole Body Vibration, Infant, Motor development, Physiotherapy