Effect of Botulinum Toxin A Injections and Specific Intensive Rehabilitation Therapy in Children with Hemiparetic Cerebral Palsy on Upper Limb Functions and Skills

Phase 3

Completed

Conditions: congenital hemiparesis
Spastic hemiparetic cerebral palsy
10010335

Registration Number: NL-OMON30186

Lead Sponsor: Hoensbroek Revalidatiecentrum (HRC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The Assisting Hand Assessment (AHA), a measurement instrument in which the<br /><br>performance and capacity of use of the affected hand in bimanual play is scored<br /><br>in a standardized way by video observation.<br /><br>The most important bimanual goal for the child and their parents will be scored<br /><br>by Goal Attainment Scaling (GAS) and by video observation. Standardized video<br /><br>observation will also be used in scoring videos of two fine motor and one gross<br /><br>motor bimanual task.<br /><br>These are all measurements at activity level of the International<br /><br>Classification of Functioning Disability and Health (ICF, WHO 2001). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Also measurements at ICF function level will be used like passive and active<br /><br>Range Of Motion (ROM), muscle strength, spasticity and movement velocity.</p><br>