Objective: to determine whether botulinum toxin A (btA) injections, intensive bimanual skill training, or a combination of both leads to more and better use of the affected arm in hemiparetic children in play, leisure time, school and personal care…
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Assisting Hand Assessment (AHA), a measurement instrument in which the
performance and capacity of use of the affected hand in bimanual play is scored
in a standardized way by video observation.
The most important bimanual goal for the child and their parents will be scored
by Goal Attainment Scaling (GAS) and by video observation. Standardized video
observation will also be used in scoring videos of two fine motor and one gross
motor bimanual task.
These are all measurements at activity level of the International
Classification of Functioning Disability and Health (ICF, WHO 2001).
Secondary outcome
Also measurements at ICF function level will be used like passive and active
Range Of Motion (ROM), muscle strength, spasticity and movement velocity.
Background summary
Rationale: at the moment there is no sufficient evidence to support or refute
the use of intramuscular injections of Botulinum toxin A (btA) as an adjunct to
managing the upper limb in children with spastic Cerebral Palsy (CP).
Rehabilitation therapy programs aimed at improving the performance and use of
the affected hand in bimanual skills are not clearly defined. Evaluation of
these therapy programs did not yet take place.
Study objective
Objective: to determine whether botulinum toxin A (btA) injections, intensive
bimanual skill training, or a combination of both leads to more and better use
of the affected arm in hemiparetic children in play, leisure time, school and
personal care.
Study design
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.
Intervention
In this study Dysport® will be used. For Dysport® (dilution 25U/0.1ml) three
times the dose of Botox® will be taken: 6-9 U/kg bodyweight above elbow, 3-6
U/kg bodyweight in fore arm, limited to no more than 150 units at any one site.
In the intrinsic thumb muscles the maximum dose will be 25U per muscle. A
maximum Dysport® dose of 1000U/total bodyweight will be used in the present
study.
The therapy programme for the children in group A and C consists of 3 times 30
minutes of physiotherapy and 30 minutes of occupational therapy, by experienced
child therapists, 2 or 3 visites a week during 3 months.
Study burden and risks
The btA injections will be administered in the day care department of the
hospital under general anaesthesia. No serious side effects of btA in the upper
limb are reported until now. The rehabilitation therapy programme contains
physiotherapy and occupational therapy half an hour each three times a week
during 12 weeks. Six measurement sessions will take place in a period of 30
weeks, each lasting 3 hours.
Onderstestraat 29
6301 KA Valkenburg
NL
Onderstestraat 29
6301 KA Valkenburg
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002175-40-NL |
| CCMO | NL12005.096.06 |