NL-OMON30186
Completed
Phase 3
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)
Hoensbroek Revalidatiecentrum (HRC)0 sites60 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- congenital hemiparesis
- Sponsor
- Hoensbroek Revalidatiecentrum (HRC)
- Enrollment
- 60
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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, phenolisation 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
Outcomes
Primary Outcomes
Not specified
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