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Trial registered on ANZCTR


Trial ID
ACTRN12605000002684
Ethics application status
Approved
Date submitted
7/07/2005
Date registered
8/07/2005
Date last updated
25/01/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the effect of modified constraint induced movement therapy or conventional occupational therapy following injection of botulinum toxin-A to improve bimanual performance in children with hemiplegic cerebral palsy.
Scientific title
A randomised controlled trial to evaluate the effect of modified constraint induced movement therapy or conventional occupational therapy following injection of botulinum toxin-A to improve bimanual performance in children with hemiplegic cerebral palsy.
Secondary ID [1] 291008 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemiplegic Cerebral Palsy 64 0
Condition category
Condition code
Neurological 75 75 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 76 76 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study Group - Upper limb injections of Botulinum toxin-A & modified Constraint Induced Movement Therapy using a neoprene mitt for 3 hours per day for 2 months.
Intervention code [1] 3 0
Rehabilitation
Comparator / control treatment
Control Group - Upper limb injections of Botulinum toxin-A & conventional Occupational Therapy for 2 months.
Control group
Active

Outcomes
Primary outcome [1] 108 0
Bimanual performance (Assisting Hand Assessment)
Timepoint [1] 108 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection
Secondary outcome [1] 238 0
Quality of Movement - Quality of Upper Extremity Skills Test (QUEST).
Timepoint [1] 238 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.
Secondary outcome [2] 239 0
Spasticity - modified Tardieu scale Muscle tone - modified Ashworth scale Passive Range of Movement - Goniometry.
Timepoint [2] 239 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.
Secondary outcome [3] 240 0
Caregiver Assistance
Timepoint [3] 240 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.
Secondary outcome [4] 241 0
Pediatric Evaluation of Disability Index (PEDI) Frequency of Use - Pediatric Motor Activity Log (PMAL).
Timepoint [4] 241 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.
Secondary outcome [5] 242 0
Individual Goal Setting
Timepoint [5] 242 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.
Secondary outcome [6] 243 0
Canadian Occupational Performance Measure (COPM) & Goal Attainment Scaling (GAS).
Timepoint [6] 243 0
At baseline, 1 month, 3 months and 6 months post Boutlinum toxin injection.

Eligibility
Key inclusion criteria
Diagnosis of spastic hemiplegic cerebral palsy; activie movement of the shoulder, elbow, wrist, digits and thumb; able to grasp a 1 inch cube from a table top and release it into a large container; ability to attend to tasks and follow simple one stage commands; moderate levels of muscle tone and spasticity; no fixed contracture in target group of muscles to be injected with Botulinum toxin-A.
Minimum age
18 Months
Maximum age
6 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous Botulinum toxin-A injections in the upper limb in the past twelve months; prior upper limb surgery (ie. tendon transfer/tendon lengthening); families do not agree to cease all other alternative upper limb therapies.

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)
Set of random numbers will be used to create a sequence contained in individual opaque envelopes for use by the researcher. As participants are recruited, the next envelope in the sequence is opened and the participant assigned to the stated group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Subjects are block randomised matched by age (+/- 6 months) using a computer generated set of random number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
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)
Recruitment hospital [1] 7388 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 15181 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 105 0
Commercial sector/Industry
Name [1] 105 0
Allergan Australia
Address [1] 105 0
Country [1] 105 0
Australia
Funding source category [2] 106 0
Government body
Name [2] 106 0
Southern Health Rehabilitation
Address [2] 106 0
Country [2] 106 0
Australia
Primary sponsor type
Government body
Name
Southern Health
Address
Country
Australia
Secondary sponsor category [1] 81 0
None
Name [1] 81 0
Nil
Address [1] 81 0
Country [1] 81 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 817 0
Southern Health & La Trobe University
Ethics committee address [1] 817 0
Ethics committee country [1] 817 0
Australia
Date submitted for ethics approval [1] 817 0
12/01/2003
Approval date [1] 817 0
05/01/2003
Ethics approval number [1] 817 0

Summary
Brief summary
Trial website
Trial related presentations / publications
1. Hoare B, Imms C, Villanueva E, Rawicki HB, Matyas T, Carey L. Intensive therapy following upper limb botulinum toxin A injection in young children with unilateral cerebral palsy: a randomized trial. Developmental Medicine & Child Neurology. 2013;55(3):238-47.

2. Hoare BJ, Imms C, Rawicki HB, Carey L. Modified constraint-induced movement therapy or bimanual occupational therapy following injection of Botulinum toxin-A to improve bimanual performance in young children with hemiplegic cerebral palsy: a randomised controlled trial methods paper. BMC Neurology. 2010;10:58.
Public notes

Contacts
Principal investigator
Name 36202 0
Dr Brian Hoare
Address 36202 0
Monash Medical Centre, Paediatric Rehabilitation, Level 4
246 Clayton Rd
Country 36202 0
Australia
Phone 36202 0
95944620
Fax 36202 0
Email 36202 0
brian.hoare@monashhealth.org
Contact person for public queries
Name 9192 0
Dr Brian Hoare
Address 9192 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 9192 0
Australia
Phone 9192 0
+61 3 95942270
Fax 9192 0
+61 3 95946444
Email 9192 0
brian.hoare@southernhealth.org.au
Contact person for scientific queries
Name 120 0
Dr Brian Hoare
Address 120 0
Monash Medical Centre
246 Clayton Road
Clayton VIC 3168
Country 120 0
Australia
Phone 120 0
+61 3 95942270
Fax 120 0
+61 3 95946444
Email 120 0
brian.hoare@southernhealth.org.au