Cerebral Palsy (CP)NCT01491152
Pilot Study of Whole Body Vibration for Children With Cerebral Palsy (CP) From 12 Months of Age
A study testing Galileo® tilt table for children in people with Cerebral Palsy (CP), run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 24 months
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Galileo® tilt table for children
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
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)
- Being tested
- Galileo® tilt table for children
- Keywords
- Cerebral Palsy, Whole Body Vibration, Infant, Motor development, Physiotherapy
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Galileo® tilt table for childrenDevice
Also called Novotec Medical, Pforzheim, Germany
Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)
| Study group | Role | What they receive |
|---|---|---|
| WBV Training | Experimental | Not described Receives: Device: Galileo® tilt table for children |
| Control | No intervention | No WBV Training. Standard of Care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of gross motor function (GMFM-66)
Measured: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Secondary outcomes (4)
Participation in activities in daily life (PEDI)
Measured: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Health-related quality of life (PedsQL)
Measured: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Passive Range of Motion (PROM)
Measured: 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.
Measured: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina Stark, University of Cologne
- Investigators
- Christina Stark, MSc., Principal investigator, Children's Hospital University of ColognePeter Herkenrath, Dr., Principal investigator, Children's Hospital University of CologneEckhard Schoenau, Prof., Study chair, Children's Hospital University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01491152
- Sponsor's protocol ID
- Uni-Koeln-1527
- Status last verified
- Sep 2013
- First submitted
- 9 Dec 2011
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Side-alternating Whole Body Vibration in Children With Cerebral Palsy (CP) From 12 Months of Age - Pilot Study
- ClinicalTrials.gov ID
- NCT01491152
- Acronym / sponsor ID
- Uni-Koeln-1527
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral Palsy, Whole Body Vibration, Infant, Motor development, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WBV Training | Experimental | Device: Galileo® tilt table for children |
| Control | No intervention | –No WBV Training. Standard of Care. |
Who may qualify
- Ages
- 12 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Galileo® tilt table for childrenAlso: Novotec Medical, Pforzheim, GermanyTwo weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table) | Device | WBV Training |
Primary outcome
Change of gross motor function (GMFM-66)
Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
4 secondary outcomes
Participation in activities in daily life (PEDI)
Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Health-related quality of life (PedsQL)
Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Passive Range of Motion (PROM)
Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Training compliance
Time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Stark, MSc. principal investigator
Children's Hospital University of Cologne
Peter Herkenrath, Dr. principal investigator
Children's Hospital University of Cologne
Eckhard Schoenau, Prof. study chair
Children's Hospital University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Galileo® tilt table for children in people with Cerebral Palsy (CP), run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of gross motor function (GMFM-66) (time frame: Baseline (T0), week 14 (T1, after training) und week 28 (T2, after follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2014.