|- candidate number||0|
|- NTR Number||NTR41|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||26-mei-2005|
|- Secondary IDs||Stichting Bio-Kinderrevalidatie (PGO 01-0134) |
|- Public Title||Effect of botulinum toxin treatment in children with cerebral palsy.|
|- Scientific Title||The effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy.|
|- ACRONYM||The BOLIEN project|
|- hypothesis||Multi-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) studied||Cerebral palsy|
|- Inclusion criteria||1. 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 criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2001|
|- planned closingdate||1-aug-2006|
|- Target number of participants||47|
|- Interventions||Group A will receive multi-level BTX injections 6 weeks after the first assessment, group B after 30 weeks.|
|- Primary outcome||1. Gross Motor Function Measure (GMFM);|
2. Energy cost of walking.
|- Secondary outcome||1. 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.
|- Trial web site||http://www.vumc.nl/revalidatie/onderzoek|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Prof. Dr. J.G. Becher|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. J.G. Becher|
|- Sponsor/Initiator ||VU University Medical Center, Department of Rehabilitation Medicine, VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|Johanna Kinderfonds, Prinses Beatrix Fonds, Stichting Bio-Kinderrevalidatie|
|- Publications||Arch Phys Med Rehabil. 2006 Dec;87(12):1551-8.|
|- Brief summary||National (dutch) multicenter trial; |
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.
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)|
|- RECORD||13-jul-2005 - 2-dec-2008|