Cerebral palsy Nervous System Diseases Cerebral palsy
Conditions
Interventions
This study will take place in three hospitals in the Netherlands: University Hospital Maastricht (Franciscusoord Valkenburg), Maartenskliniek Nijmegen Hospital and Free University Medical Centre (Vrij
Sponsors
Ipsen Biopharm Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Assisted Hand Assessment (AHA): original test kit for children 2.5 - 6 years and board game for children 7 - 12 years (T2, T4, T6) 2. A measure of manual ability for children with upper limb impairments (ABILHAND)-Kids questionnaire (T1 - T6) 3. Canadian Occupational Performance Measure (COPM): establishing treatment goals; Goal Attainment Scaling (GAS) of the most important bimanual treatment goal (T1, T4, T6) 4. Video recording of two fine motor tasks (children 7 - 12 years: buttering and cutting bread, screw construction task; children 2.5 - 6 years: building with 'poppons', threading beads) and one gross motor task (children 2.5 - 6 years: building blocks; children 7 - 12 years: stacking cylinders). These videos will be scored with newly developed and reliability tested Video Observation (VO) criteria (T2, T6). T1 and T2: Baseline T3: 6 weeks after btA and start of the therapy program T4: 12 weeks, end of therapy program T5: 18 weeks T6: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Wrist and elbow tone and Tardieu Scale or Spasticity Test (SPAT): supine and sitting (T1 - T6) 2. Active and passive range of motion (ROM) of wrist (with fisted hand and with extended fingers), and of elbow and thumb (T1 - T6) 3. Grip strength: E-link (biometrics®) and functional grip strength (T1 - T6) T1 and T2: Baseline T3: 6 weeks after btA and start of the therapy program T4: 12 weeks, end of therapy program T5: 18 weeks T6: 24 weeks | — |
Countries
Netherlands
Outcome results
None listed