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.
Conditions
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion 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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to investigate the effect of Botulinum Toxin A and a specific intensive rehabilitation therapy in children with hemiparetic CP in order to improve the use of their affected arm. For hemiparetic children more and better use of the affected arm in play, leisure time, school activities and personal care is of importance. Therefore, measurements should be aimed at activity level of the ICF and it should be possible to assess and score these measurements blindly. Also it should be possible to discriminate between the effect of the btA injections and the effect of the rehabilitation therapy program. ;Secondary Objective: If proven effective this treatment approach will be implemented in the participating centres.;Primary end point(s): Children will be included according to the inclusion criteria. After the first two measurement sessions, block randomisation takes place in each location (SRL/AZM, VUMC, and Maartenskliniek). To improve the chance of getting groups with equal age distributions, the randomisation will be carried out after stratification in two age groups: 2.5-6 years and 7-12 years. When a block of four children per age stratum and centre is filled, randomisation into the four treatment groups will take place. Group A and B receive the btA injections. In group A the injections are followed by a rehabilitation therapy program specifically aimed at improving hand function and bimanual skills. In group B the injections are followed by therapy as usual (i.e. maximum once a week and not specifically aimed at hand function). Group C only receives the therapy program for three months. The children in group D continue with their usual therapy. 60 children in total will be included. After the last measurement t6, i.e. 24 weeks after start of the treatment the study will end. | — |
Countries
Netherlands
Outcome results
None listed