Effect of botulinum toxin treatment in children with cerebral palsy

Completed

• Conditions: Cerebral parese (cerebral palsy); Nervous System Diseases; Cerebral palsy

• Registration Number: ISRCTN35169306
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 47

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Gross Motor Function Measure (GMFM)<br>2. Energy cost of walking

Secondary Outcome Measures

Name	Time	Method
1. Spasticity of the treated muscles<br>2. Passive range of motion of lower extremity joints<br>3. Edinburgh Visual Gait score (GAIT)<br>4. Paediatric Evaluation Disability Inventory (PEDI), domain ?mobility?<br>5. Problem score