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Learn 2 Move 7-12: Effectiveness of an activity stimulation program on performance of mobility and lifestyle in school-aged children with cerebral palsy.


- candidate number6706
- NTR NumberNTR2099
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-nov-2009
- Secondary IDs2009/14 METC VUmc
- Public TitleLearn 2 Move 7-12: Effectiveness of an activity stimulation program on performance of mobility and lifestyle in school-aged children with cerebral palsy.
- Scientific TitleLearn 2 Move 7-12: Effectiveness of an activity stimulation program on performance of mobility and lifestyle in school-aged children with cerebral palsy.
- ACRONYMLEARN 2 MOVE 7-12
- hypothesisAn activity stimulation program improves mobility performance and fitness in children with cerebral palsy.
- Healt Condition(s) or Problem(s) studiedCerebral palsy, Children
- Inclusion criteria1. Age 7 to 12 years;
2. Diagnosis spastic cerebral palsy based on published diagnostic criteria (2);
3. Able to walk with or without assistive devices, that means, class I to III on the GMFCS.
- Exclusion criteria1. If they underwent surgery (<6 months ago) or botuline toxine treatment (<3 months ago);
2. If they have cardiovascular contraindications or other medical conditions that may interfere with physical training;
3. If they are unable to follow simple instructions;
4. Have behavioural problems that interfere with participating in a group training;
5. Have predominant dyskinetic or atactic movement disorder.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-sep-2012
- Target number of participants50
- InterventionsParticipants are randomised in either the control group or the experimental group. The control group follows their regular physiotherapy and the experimental group follows the activity stimulation program.

An activity stimulation program consisting of:
1. Physical group training (4 months), and parallel;
2. A tailored life style intervention (6 months).

- Primary outcomePerformance of mobility:
1. Physical activity measured by 7-days accelerometry (Stepwatch);
2. Self reported activities (CAPE, AQUA, Functional Mobility Scale).
- Secondary outcome1. Capacity of mobility (GMFM-66 and functional leg strength, walking ability);
2. Fitness (isometric muscle strength, anaerobic capacity, aerobic capacity); 3. Health related quality of life and fatigue;
4. Self concept.
- Timepoints1. Pretetst at baseline;
2. Fitness tests at 4 months;
3. Fitness and physical activity at 6 months;
4. Follow-up measurement at 12 months.
- Trial web sitehttp://www.vumc.nl/afdelingen/revalidatiegeneeskunde/000reva/Onderzoek/klinischetrials/1893956/
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Leontien Wely, van
- CONTACT for SCIENTIFIC QUERIES Leontien Wely, van
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Johanna Kinderfonds, Revalidatiefonds, Phelps Stichting, Kinderfonds Adriaanstichting
- Publicationsnot yet
- Brief summaryBACKGROUND:
Children with CP show reduced levels of physical activity compared to typically developing peers. Especially in CP children, physical activity is important, since it may prevent a decrease in mobility and decreases the risk for secondary complications due to inactivity.

OBJECTIVE:
The aim of the study is to evaluate the effectiveness of an activity stimulation program on performance of mobility and lifestyle in children with cerebral palsy, in comparison with regular paediatric physiotherapy.

PARTICIPANTS:
A total of 50 ambulatory children (age 7-12 years) with cerebral palsy, GMFCS I-III (walking with or without walking aids).

DESIGN:
A six-months single blinded randomized controlled clinical trial with a six-month follow-up will be performed in local centres for paediatric physiotherapy and special schools for disabled children between June 2009 and October 2011. Participants are randomised in either the control group or the experimental group. The control group follows their regular physiotherapy and the experimental group follows the activity stimulation program.

INTERVENTION:
The intervention is an activity stimulation program that consists of: 1) physical group training (4 months), and parallel, 2) a life style intervention (6 months). The lifestyle intervention includes home-based mobility training and counselling sessions towards a more active lifestyle. Content of the lifestyle intervention is individually defined.

MEASUREMENTS:
Measurements will be performed directly before randomization, after four months, after six months (end of intervention) and after one year (six-months follow-up). Primary outcomes are performance of mobility (StepWatch activity monitor, questionnaires). Secondary outcomes are fitness, capacity of mobility, participation, quality of life, fatigue and self-concept.
- Main changes (audit trail)
- RECORD10-nov-2009 - 29-nov-2009


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