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van CCT (UK)

van CCT (UK)

Effect of a lower-limb PRE strength-training program on physical functioning in children with cerebral palsy

- candidate number3826
- NTR NumberNTR1403
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-aug-2008
- Secondary IDsWC05-043 
- Public TitleEffect of a lower-limb PRE strength-training program on physical functioning in children with cerebral palsy
- Scientific TitleEffect of a strength-training program on physical functioning in children with cerebral palsy
- ACRONYMthe Popeye study
- hypothesisWe hypothesize that children who will follow this structured functional PRE strength training program will increase in muscle strength, which accordingly will lead to functional improvement in physical functioning, but with no negative effect increasing spasticity or decreasing range of motion, compared to children receiving usual care.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Children, Muscle strength, Progressive resistance exercise (PRE) , Physical therapy
- Inclusion criteria1. Age between 6 and 13 years
2. Able to accept and follow verbal instructions
3. Ability to walk independently indoors, with or without walking aids (Gross Motor Function Classification System [GMFCS] levels I – III)
4. Able to participate in a group training program
5. Attending a school for physically disabled children
- Exclusion criteria1. Instable seizures
2. Received treatment for spasticity or surgical procedures up to 3 months (for botulinum toxin type A injections) to 6 months (for surgery) prior to the study (or planned in the study period)
3. Expect any change in medication during the study period
4. Suffer from other diseases that interfered with physical activity.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate1-sep-2009
- Target number of participants50
- InterventionsUsing stratified randomization, each child is assigned to an intervention group (strength training) or a control group (usual care).
The strength training is given in groups of 4-5 children, 3 times a week, for a period of 12 weeks. Each training session focusses on four exercises out of a 5-exercise circuit. The exercise are maily functional, aiming at a maximal carry-over into everyday activities. The training load is gradually increased based on the child’s maximum level of strength, as determined by the 8 Repetition Maximum (8RM).
- Primary outcomePhysical functioning is measured as gross motor function and walking ability

Gross motor function:
- Gross Motor Function Measure (GMFM)
- Functional muscle strength tests (30 second Lateral Step Up test; 30 second Sit to Stand test)

Walking ability
- The 10-meter walk test
- The 1-minute walk test
- The timed stair test
- Secondary outcomeLower limb muscle strength
- 6RM test
- Isometric muscle strength tests of 5 lower limb muscles using hand-held dynamometry(knee flexors and extensors, hip flexors and abductors, ankle plantar flexors)
- Lower limb sprint capacity test (Wingate test)

- The mobility questionnaire (MobQues)

Sport activities
- The Children's Assessment of Participation and Enjoyment (CAPE)

Advers events:
- Spasticity
- Range of motion
- TimepointsTo evaluate the effectiveness of the training, all children are evaluated before, during, directly after, and 6 weeks after the intervention period.
- Trial web site
- statusstopped: trial finished
- Sponsor/Initiator VU University Medical Center, Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Dr. W.M. Phelps-stichting voor spastici, The Adriaanstichting
- PublicationsN/A
- Brief summaryChildren with CP experience limitations in activities and participation, which is mainly caused by impairments in muscle function. Not only spasticity contributes to impaired muscle function, but also muscle weakness can be regarded as a serious denominator of impaired muscle function. Strength training is therefore expected to reduce limitations in activities of children with CP who will encounter life long disability. The purpose of this study is to determine the effects of a strength-training program on physical functioning in children with CP.
- Main changes (audit trail)
- RECORD13-aug-2008 - 22-aug-2008

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