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Effect of botulinum toxin treatment in children with cerebral palsy.


- candidate number0
- NTR NumberNTR41
- ISRCTNISRCTN35169306
- Date ISRCTN created5-aug-2005
- date ISRCTN requested18-jul-2005
- Date Registered NTR26-mei-2005
- Secondary IDsStichting Bio-Kinderrevalidatie (PGO 01-0134) 
- Public TitleEffect of botulinum toxin treatment in children with cerebral palsy.
- Scientific TitleThe effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy.
- ACRONYMThe BOLIEN project
- hypothesisMulti-level botulinum toxin-A (BTX-A) treatment of the lower extremities in combination with comprehensive rehabilitation leads to an improvement in mobility of children with cerebral palsy.
- Healt Condition(s) or Problem(s) studiedCerebral palsy
- Inclusion criteria1. Diagnosis of cerebral palsy (CP), hemiplegia or diplegia, ability to walk with or without a walking aid, with or without an ankle-foot orthosis;
2. gait characterized by persistent flexion of the hip and knee in mid-stance when walking;
3. age between 4 and 12 years.
- Exclusion criteria1. BTX treatment in lower extremities 16 weeks before inclusion;
2. Orthopaedic surgery 24 weeks before inclusion;
3. Contra-indication for BTX-A;
4. Contra-indication for general anaesthesia;
5. Severe fixed contractures;
6. Orthopaedic deformities, which have a bad influence walking:
6.1 (Sub)luxation of the hip with a migration index > 50 degrees;
6.2 Hip endorotation contracture > 15 degrees;
6.3 Flexion contracture of knee > 15 degrees;
7. Presence of ataxia of dyskinesia;
8. Other problems which have a negative influence on walking.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2001
- planned closingdate1-aug-2006
- Target number of participants47
- InterventionsGroup A will receive multi-level BTX injections 6 weeks after the first assessment, group B after 30 weeks.
- Primary outcome1. Gross Motor Function Measure (GMFM);
2. Energy cost of walking.
- Secondary outcome1. Spasticity of the treated muscles;
2. Passive range of motion of lower extremity joints;
3. Edinburgh Visual Gait score (GAIT);
4. Pediatric Evaluation Disability Inventory (PEDI), domain ‘mobility’;
5. Problem score.
- TimepointsN/A
- Trial web sitehttp://www.vumc.nl/revalidatie/onderzoek
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESProf. Dr. J.G. Becher
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.G. Becher
- Sponsor/Initiator VU University Medical Center, Department of Rehabilitation Medicine, VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
Johanna Kinderfonds, Prinses Beatrix Fonds, Stichting Bio-Kinderrevalidatie
- PublicationsArch Phys Med Rehabil. 2006 Dec;87(12):1551-8.
- Brief summaryNational (dutch) multicenter trial;
Intervention:
Multilevel treatment with botulinum toxin A (BTX). Possible target muscles for a multi-level treatment are the psoas, medial/lateral hamstrings, hip-adductors, rectus femoris, triceps surae, and tibialis anterior/posterior unilateral or bilateral. Starting one week after the multi-level BTX-injections, the patients will be treated by a physiotherapist according to a standardized treatment protocol for 12 weeks.


Randomisation:
The patients will be randomized into two groups in a multiple baseline design. Follow-up measurements will be performed at 6, 12, 24 and 48 weeks.


Uitkomstmaten (prim sec?):
Gross Motor Function Measure (GMFM), energy cost of walking, gait analysis, mobility questionnaire, spasticity, and passive range of motion of lower extremity joints.
- Main changes (audit trail)
- RECORD13-jul-2005 - 2-dec-2008


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