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NCT Number: NCT01491152

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

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.

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Key information

Conditions

Cerebral Palsy (CP) Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases

Age range

12 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital University of Cologne

Cologne, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Galileo® tilt table for children

Device

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

Other names: Novotec Medical, Pforzheim, Germany

Primary outcomes

  1. Change of gross motor function (GMFM-66)

    Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

Secondary outcomes

  1. Participation in activities in daily life (PEDI)

    Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

  2. Health-related quality of life (PedsQL)

    Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

  3. Passive Range of Motion (PROM)

    Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

  4. Training compliance

    Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)

    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.

Sponsors and collaborators

Lead sponsor

University of Cologne

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2011
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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