Effect of botulinum toxin A injections and specific intensive rehabilitation therapy in children with hemiparetic cerebral palsy on upper limb functions and skills

Not Applicable

Completed

• Conditions: Cerebral palsy; Nervous System Diseases

• Registration Number: ISRCTN69541857
• Lead Sponsor: Ipsen Biopharm Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03-31
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Aged 2.5 - 12 years, either sex
2. Cerebral palsy
3. Hagberg diagnosis: spastic hemiparesis or extreme asymmetric diplegia
4. Hand function impairment Zancolli grade I with evident problems in thumb extension and supination, Zancolli grade IIA and IIB
5. Mentally able to comprehend and perform tasks
6. Children and their parents should be able to cope with the intensive rehabilitation therapy programme and the measurement sessions
7. Children and the parents/caregivers should comprehend and speak Dutch
8. Children and their parents indicate the necessity for improvement of the children's abilities

Exclusion Criteria

1. Severe structural contractures of the muscles at the extremity to be treated:
1.1. Passive elbow extension maximum 160 degrees or less
1.2. Supination maximum 30 degrees or less from neutral position
1.3. Wrist dorsal flexion maximum 20 degrees or less in children aged 2.5 - 6 years, or 45 degrees or less in age group 7 - 12 years
2. Severe impairment of hand function: no active hand function is expected after treatment (Zancolli III)
3. Hand surgery or phenolisation or btA injections in the arm less than nine months ago
4. Contraindication for botulinum toxin (muscular diseases such as myasthenia gravis, tetanus vaccination less than three months before the injection, use of aminoglycoside antibiotics or spectinomycine and known hypersensitivity for human albumin)
5. Contraindication for anaesthesia
6. Children who cannot bear touching the affected arm and hand

Study & Design

• Study Type: Interventional
• Study Design: Not specified