None listed
Conditions
Brief summary
Cerebral palsy is the most common physical disability in childhood, with a significant lifelong impact on the person, their family and the community. It is estimated that 1:400 children are born with cerebral palsy (Stanley et al, 2000), with over 600 new cases diagnosed in Australia each year. At present there is no known cure for this condition (Stanley et al, 2000) however the methods for the treatment of its symptoms, such as muscle spasticity, are well documented. It is known that the combination of occupational therapy along with botulinum toxin (BOTOX) injections (Lowe, Novak & Cusick, 2005; Wallen, O’Flaherty & Waugh 2004) and best-practice home programs (Novak, Cusick & Lowe, 2005) can produce positive outcomes for improving function and manage the symptoms of spasticity in children with cerebral palsy (Corry & Graham, 1994; Delago, 2002; Leach, 1997; Russman, Tilton & Gromley, 1997). It is therefore worth investigating the nature and extent of parental input and determine whether or not intensive provider delivered therapy intervention following upper limb botulinum toxin injections will lead to greater desirable outcome in the daily functioning of a child with cerebral palsy. The results of this research project will provide valuable data for determining therapy intensity and the conditions and processes that affect the treatment process. This will help inform decisions by health professionals and families regarding the type, amount, model and method of therapy to be used following BOTOX® injections, thus guiding best practice, use of time, resources and funding in the treatment of spasticity in children with cerebral palsy. There is thus a clear gap in research literature regarding provider-based intense therapy effectiveness that needs to be filled.
Interventions
Physiotherapy and Occupational Therapy. Group 1 will receive intense hands-on therapy 3 times per week for 4 weeks, then take a 4 week break with no therapy then repeat the 4 weeks intense therapy 3 times per week (12 weeks duration). Group 2 will receive regular therapy, 1 times per week for 4 weeks, then fortnightly for 4 weeks, then monthly (12 weeks duration). Group 3 will receive a individualised home program with 2 support appointments to be carried out for 12 weeks duration.
Sponsors
The Spastic Centre of NSW, Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of cerebral palsy 2. Have received BOTOX® in the last 4 weeks from one of the children’s hospitals 3. Eligible for services from The Spastic Centre 4. Functional ability to use the affected limb/s for at least assisted ambulation, or attempts to grip a palm sized toy on request OR of BOTOX® was given for reduction of caregiver burden 5. Informed consent is given.
Exclusion criteria
1. Diagnosis is not cerebral palsy2. Botulinum toxin is injected greater than 4 weeks prior to enrollment3. Consent is not given4. Client is not eligible for standard therapy services from The Spastic Centre of NSW.
Outcome results
None listed