Effect of botulinum toxin treatment in children with cerebral palsy
| ISRCTN | ISRCTN35169306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35169306 |
| Protocol serial number | Stichting Bio-Kinderrevalidatie (PGO 01-0134); NTR41 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funders | Princess Beatrix Funds (Prinses Beatrix Fonds) (The Netherlands), Johanna Kinderfonds (The Netherlands), Foundation for Paediatric Rehabilitation (Stichting Bio-Kinderrevalidatie) (The Netherlands) |
- Submission date
- 04/08/2005
- Registration date
- 04/08/2005
- Last edited
- 11/06/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof J.G. Becher
Scientific
Scientific
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
| Phone | +31 (0)20 444 0763 |
|---|---|
| reva@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | The effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy |
| Study acronym | The BOLIEN project |
| Study objectives | 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. |
| Ethics approval(s) | Ethics approval received from the local ethics committee. |
| Health condition(s) or problem(s) studied | Cerebral parese (cerebral palsy) |
| Intervention | Group A: multi-level BTX injections 6 weeks after the first assessment Group B: multi-level BTX injections 30 weeks after the first assessment Intervention: Multi-level 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 standardised treatment protocol for 12 weeks. Randomisation: The patients will be randomised into two groups in a multiple baseline design. Follow-up measurements will be performed at 6, 12, 24 and 48 weeks. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Botulinum toxin |
| Primary outcome measure(s) |
1. Gross Motor Function Measure (GMFM) |
| Key secondary outcome measure(s) |
1. Spasticity of the treated muscles |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | All |
| Target sample size at registration | 47 |
| Key inclusion criteria | 1. Diagnosis of cerebral palsy (CP), hemiplegia or diplegia 2. Ability to walk with or without a walking aid, with or without an ankle-foot orthosis 2. Gait characterised by persistent flexion of the hip and knee in mid-stance when walking 3. Aged between 4 and 12 years |
| Key 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 on walking: 6.1. (Sub)luxation of the hip with a migration index greater than 50 degrees 6.2. Hip endorotation contracture greater than 15 degrees 6.3. Flexion contracture of knee greater than 15 degrees 7. Presence of ataxia of dyskinesia 8. Other problems which have a negative influence on walking |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
1007 MB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
