Effect of Botulinum Toxin A Injections and Specific Intensive Rehabilitation Therapy in Children with Hemiparetic Cerebral Palsy on Upper Limb Functions and Skills - BoBiVa (Botuline toxine Bimanuele Vaardigheden)

Conditions: Study design: a factorial design with four study groups in which btA alone, intensive rehabilitation therapy aimed at improving bimanual skills alone, a combination of these two and continuing the regular therapy program will be compared to each other.Study population: children with CP, spastic hemiparesis, aged 2.5 – 12 years.

Registration Number: EUCTR2006-002175-40-NL

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

•Age 2,5 – 12 years
•Cerebral Palsy
•Hagberg diagnosis: spastic hemiparesis or extreme asymmetric diplegia
•Hand function impairment Zancolli grade I with evident problems in thumb extension and supination, Zancolli grade IIA and IIB (Zancolli E.A., 1987)
•Mentally able to comprehend and perform tasks
•Children and their parents should be able to cope with the intensive rehabilitation therapy programme and the measurement sessions
•Children and the parents/caregivers should comprehend and speak Dutch
•Children and their parents indicate the necessity for improvement of the children‘s abilities

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Severe structural contractures of the muscles at the extremity to be treated (elbow extension deficit 20 degrees, supination deficit 45 degrees, deficit wrist dorsal flexion 30 degrees or more)
•Severe impairment of hand function, no active hand function is expected after treatment (Zancolli III)
•Hand surgery to improve function, or fenolisation or btA injections in the arm less than nine months ago
•Contra indication for botulinum toxin (children with muscular diseases, like myasthenia gravis, tetanus vaccination less than 3 months before the injection, use of aminoglycoside antibiotics or spectinomycine, known hypersensitivity for human albumin)
•Contra indication for anaesthesia
•Children who cannot bare touching the affected arm and hand