Evaluation of the effects of botulinum toxin A injections in improving ease of care and increasing comfort in children with marked cerebral palsy: a randomised controlled trial.
Phase 4
Recruiting
- Conditions
- Musculoskeletal - Normal musculoskeletal and cartilage development and functionMarked cerebral palsy:Gross Motor Function Classification System (GMFCS) 4-5
- Registration Number
- ACTRN12609000360213
- Lead Sponsor
- Qld Cerebral Palsy Health Service
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
Age 2-16 years, diagnosis of cerebral palsy classified GMFCS 4-5. Child/family have goals primarily concerned with improving care and/or comfort associated with spasticity affecting upper and/or lower limbs.
Exclusion Criteria
Medical contraindications to botulinum toxin A. Any botulinum toxin A injections occurring within 6 months of the study, any upper limb or lower limb casting within 2 months of initiation of the study, changes to oral or other spasticity management agents occuring within 2 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Parents will report burden of care as measured by the Care and comfort hypertonicity questionnaire[baseline, one month, four months following completion of the first treatment. Injections are repeated at 6 months (second baseline) with repeat measures at one month and four months following second treatment.];Parents will report overall satisfaction and performance for children in individually identified problem areas as determined by the Canadian occupational performance measure[baseline, at one month and four months. injections are repeated at 6 months with repeat measures at one month and four months following second treatment.]
- Secondary Outcome Measures
Name Time Method Parents will report quality of life as determined by the cerebral palsy (CP) quality of life tool: Cerebral Palsy Quality of Life (CPQoL) and child's health status as determined by health utility measure CP child.[baseline, one monthand four months following the first treatment. Injections are repeated at 6 months with repeat measures at one month and four months following this treatment.];Patients and parents will report a pain as recorded by the paediatric pain profile[baseline, one month, four month following initial injections. injections are repeated 6 months following initial injections (second baseline) with review points at one month and four months following these second injections.]