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Effect of botulinum toxin treatment in children with cerebral palsy.

The effect of multi-level botulinum toxin treatment and intensive rehabilitation on walking ability in children with cerebral palsy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON21315
Enrollment
47
Registered
2005-05-26
Start date
2001-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Group A will receive multi-level BTX injections 6 weeks after the first assessment, group B after 30 weeks.

Sponsors

None listed

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
1. Gross Motor Function Measure (GMFM); 2. Energy cost of walking.

Secondary

MeasureTime frame
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.

Contacts

Public ContactJ.G. Becher

VU University Medical Center, P.O. Box 7057

reva@vumc.nl+31 (0)20 4440763

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)