No registrations found.
ID
Source
Brief title
Intervention
Outcome measures
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.
Background summary
National (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.
Study objective
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.
Study design
N/A
Intervention
Group A will receive multi-level BTX injections 6 weeks after the first assessment, group B after 30 weeks.
P.O. Box 7057
J.G. Becher
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440763
reva@vumc.nl
P.O. Box 7057
J.G. Becher
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440763
reva@vumc.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL21 |
| NTR-old | NTR41 |
| Other | : Stichting Bio-Kinderrevalidatie (PGO 01-0134) |
| ISRCTN | ISRCTN35169306 |