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The influence of Continuous Passive Motion after knee surgery in cerebral palsy.


- candidate number14562
- NTR NumberNTR3935
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-mrt-2013
- Secondary IDss55352 MEC Univeristy Hospital Pellenberg, Belgium
- Public TitleThe influence of Continuous Passive Motion after knee surgery in cerebral palsy.
- Scientific TitleThe influence of Continuous Passive Motion after knee surgery in cerbral palsy.
- ACRONYM
- hypothesisContinuous Passive Motion in the early post-operative periode after knee surgery is beneficiary for the rehabilation process in children with cerebral palsy.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Knee, Contiuous passive motion
- Inclusion criteria1. Cerebral palsy;
2. Age < 21 years;
3. Knee surgery.
- Exclusion criteria1. No informed consent;
2. Rehabilition in other than participating hospital;
3. Patient who undergo revision will be excluded during the study.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2012
- planned closingdate1-apr-2014
- Target number of participants100
- InterventionsTroughout the whole study, all children receive their normal, classical physiotherapy programm. The intervention contains daily sessions of continuous passive motion (one hour) (either in the week 2-4 or in week 5-7 after surgery, depending on the group they are attributed to).
- Primary outcomeThe primary outcome is knee flexion range of motion (ROM) as measured with goniometry. Knee ROM willl be measured when the children go home after surgery. The measurement will be repeated when they come back for rehabilitation at week 4. From that point on ROM will be measured weekly.
- Secondary outcomePain will be noted at the same moments as the primary outcome (based on pain medication the child is administered), selectivity will be noted at the same moments as the primary outcome.
- Timepoints1. Before inclusion;
2. After 3 weeks CPM/physiotherapy;
3. After 6 weeks physiotherapy/CPM.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Patricia Walle, van de
- CONTACT for SCIENTIFIC QUERIES Patricia Walle, van de
- Sponsor/Initiator University Hospital Pellenberg, Children Orthopaedics
- Funding
(Source(s) of Monetary or Material Support)
University Hospital Pellenberg, Children Orthopaedics
- PublicationsN/A
- Brief summaryOrthopedic surgery is often needed to correct the excessive knee flexion pattern during gait in children with cerebral palsy. The first few weeks after orthopedic surgery, it is important that the knee joint is sufficiently mobilized to avoid movement restrictions and to accelerate the recovery process. These mobilizations can be performed actively by a physiotherapist or passively by a device for passive mobilization. The advantage of passive mobilization is that the patient can practice several times a day, including weekends. However, the effect of the passive mobilization on recovery has not yet been proved. In this cross-over study half of the children get daily passive mobilization (QAL Medical, OrthoAgility, 480E) besides the classical physiotherapy for 3 weeks after a multi-level knee surgery. The other half will receive only the classical physiotherapy. After 3 weeks the children exchange groups. The range of knee flexion is the primary outcome and will be measured at different timepoints.
- Main changes (audit trail)
- RECORD21-mrt-2013 - 19-apr-2013


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