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Trial registered on ANZCTR


Registration number
ACTRN12606000492550
Ethics application status
Approved
Date submitted
30/10/2006
Date registered
29/11/2006
Date last updated
24/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
"Thumbs up!"
Scientific title
Randomised double blind clinical control trial comparin injections of botulinum toxin A with saline placebo to the intrinsic muscles of the thumb in children with cerebral palsy to assess improved performance in individual goal areas as measured by goal attainment scaling.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral Palsy 1470 0
Condition category
Condition code
Neurological 1566 1566 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment group: Single episode of Botulinum toxin A (BTX-A) injections into the intrinsic muscles of the thumb (dosage of 0.5 U/kg BTX-A (max 20 units) injected into flexor pollicis brevis, opponens pollicis or adductor pollicis to a maximum total dose of 1.5 U/kg or 30 units) + casting for one week, home therapy program (to be carried out daily for 8 weeks) and resting hand splints to be worn daily (for resting time over night eg 10 hours) for 8 weeks.
Botulinum toxin A dosing to be determined by blinded physician. Muscles injected dependent upon clinical determinants of spasticity in those muscles

Home therapy programme will involve a range of activities selected according to the child's individual goals and will take approximately 20 minutes per day. For example: strengthening excercises for thumb flexors with playdoh.
Intervention code [1] 1424 0
Rehabilitation
Comparator / control treatment
Control group: Single episode of saline injections into the intrinsic muscles of the thumb (dosage dependant upon equivalent volume of BTX-A, dilution 100u/ml) injected into flexor pollicis brevis, opponens pollicis or adductor pollicis to a maximum total dose of 1.5 U/kg or 30 units) + casting for one week, home therapy program (to be carried out daily for 8 weeks) and resting hand splints to be worn daily for 8 weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2161 0
Goal attainment scaling (GAS) is an individualized outcome measurement technique developed for use in the human services field It allows for individual assessment of patient goals and standardization of measurement using a summary formula that calculates the extent to which an individual’s goals are met. Parents will be asked to nominate three to five goals relating to the use or position of the thumb and scale levels will be formulated around each goal from -2 (baseline performance), zero (expected outcome after intervention) to +2 (better than expected outcome). The formula applied to calculate GAS scores will be:
GAS score = 50 + 10?(wixi)
v (0.7 ? wi2 + 0.3 (? wi)2)
where xi = the attainment level and wi = the weight assigned to the goal area. The expected score is 50, with 100 being the best possible score post-intervention.
Administration of the GAS with the parents will be approximately 20 minutes.
Timepoint [1] 2161 0
Administered at baseline, 8 weeks post intervention and 6 months post intervention.
Secondary outcome [1] 3776 0
Quality of upper extremities skills test (QUEST), modified Ashworth scale, modified Tardieu scale, classification of thumb deformities.
Timepoint [1] 3776 0
Baseline, 8 weeks post intervention and 6 months post intervention.

Eligibility
Key inclusion criteria
1. Child receiving lower limb Botulinum Toxin-A (BTX-A)injections under general anaesthetic.2.Child >10kg 3.Lower limb BTX-A dose does not exceed 14units/kg – so as to allow for safe low dose upper limb injection (total lower limb dose not to exceed 370 units).4.Child has cerebral palsy5.Child has spasticity in adductor pollicis, opponens pollicis or flexor pollicis brevis that impacts on function, hygiene or splint tolerance.6.Parent and/or child have goals for improvement of the thumb that relate to function, care and comfort, hygiene or splint tolerance.7.Parents need to be willing to commit to a home program and occupational therapy review and outcome measure appointments.8.Written informed consent has been obtained from the parent or guardian.9.For children taking oral antispasticity medications (such as Baclofen) the dose relative to body weight must be stable for a period of 3 months prior to commencement of the study.
Minimum age
2 Years
Maximum age
12 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1.Medical contraindications to BTX-Aa.Known hypersensitivity to botulinum toxin A or the components of its formulation,b.Myasthenia gravis or Eaton-Lambert Syndrome,c.Presence of infection at injection site,2.Amyotrophic lateral sclerosis or other disorders producing a depletion of acetylcholine at the neuromuscular junction,3.Concurrent use of any drugs that interfere with neuromuscular transmission, e.g. aminoglycoside antibiotics, spectinomycin or tubocurarine-type muscle relaxants.4.Inability to commit to assessment appointments and an active home therapy program. 5.Prior surgery to thumb for spasticity or contracture management.6.Previous BTX-A treatment to the upper limb within the last 6 months.7.Oral anti-spasticity medication (e.g. baclofen) unless the dose has been stable relative to weight for at least 3 months.8.Athetosis9.Where the child uses the spasticity in the thumb for function.10.Where the child has spasticity in their long finger flexors that restricts adequate finger extension to achieve functional grasp.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Blinded parties will include: subjects and their parents, injecting doctor, treating therapist and assessing therapist
Phase
Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1706 0
Charities/Societies/Foundations
Name [1] 1706 0
Royal Childrens Hospital Foundation Brisbane
Address [1] 1706 0
Herston Road Herston Brisbane Qld 4039
Country [1] 1706 0
Australia
Funding source category [2] 1707 0
Government body
Name [2] 1707 0
Queensland Cerebral Palsy Health Service
Address [2] 1707 0
Level 2 Surgical Building
Royal childrens Hospital
Herston Road, Herston
Brisbane 4039
Country [2] 1707 0
Australia
Primary sponsor type
Individual
Name
Dr Lisa Copeland
Address
Queensland Cerebral Palsy Health Service
Level 2
Coles Building
Royal Childrens Hospital
Herston Rd
Herston Brisbane QLD 4039
Country
New Zealand
Secondary sponsor category [1] 1507 0
Individual
Name [1] 1507 0
Ms Megan Thorley
Address [1] 1507 0
Queensland Cerebral Palsy Health service
Level 2 Coles Building
Royal childrens Hospital
Herston Rd Herston
Brisbane 4039
Country [1] 1507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3164 0
Royal Children's Hospital Brisbane
Ethics committee address [1] 3164 0
Ethics committee country [1] 3164 0
Australia
Date submitted for ethics approval [1] 3164 0
Approval date [1] 3164 0
23/10/2006
Ethics approval number [1] 3164 0

Summary
Brief summary
To examine whether botulinum toxin – A (BTX-A) injections into the intrinsic muscles of the thumb, when combined with a regimen of occupational therapy and home therapy improves the attainment of individual goals when compared to a home and occupational therapy program alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27358 0
Address 27358 0
Country 27358 0
Phone 27358 0
Fax 27358 0
Email 27358 0
Contact person for public queries
Name 10613 0
Dr Lisa Copeland
Address 10613 0
Queensland Cerebral Palsy Health Service
Level 2 Surgical Building
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 10613 0
Australia
Phone 10613 0
+61 7 36365500
Fax 10613 0
+61 7 36365480
Email 10613 0
Lisa_copeland@health.qld.gov.au
Contact person for scientific queries
Name 1541 0
Ms Megan Thorley
Address 1541 0
Queensland Cerebral Palsy Health Service
Level 2 Surgical Building
Royal Children's Hospital
Herston Rd
Herston QLD 4029
Country 1541 0
Australia
Phone 1541 0
+61 7 36365500
Fax 1541 0
Email 1541 0
Megan_thorley@health.qld.gov.au

No information has been provided regarding IPD availability
Summary results
No Results