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.
ID
Bron
Verkorte titel
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Gross Motor Function Measure (GMFM);<br>
2. Energy cost of walking.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Group A will receive multi-level BTX injections 6 weeks after the first assessment, group B after 30 weeks.
Publiek
P.O. Box 7057
J.G. Becher
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440763
reva@vumc.nl
Wetenschappelijk
P.O. Box 7057
J.G. Becher
Amsterdam 1007 MB
The Netherlands
+31 (0)20 4440763
reva@vumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL21 |
| NTR-old | NTR41 |
| Ander register | : Stichting Bio-Kinderrevalidatie (PGO 01-0134) |
| ISRCTN | ISRCTN35169306 |