Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000486426
Ethics application status
Approved
Date submitted
13/09/2007
Date registered
21/09/2007
Date last updated
27/11/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of botulinum toxin a to manage upper limb spasticity in children with cerebral palsy
Scientific title
Upper limb resistance training and the use of botulinum toxin A (BTX-A) to improve upper limb function in children with cerebral palsy: An investigation of functional benefit, and peripheral and central nervous system changes.
Secondary ID [1] 288025 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
spasticity 2374 0
cerebral palsy 2375 0
botulinum toxin A 2376 0
strength training 2377 0
Condition category
Condition code
Neurological 2479 2479 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intramuscular injection of botulinum toxin A (BoNTA) to selected upper limb muscles at 0.5-2u/kg/body weight followed by resistance training at the peak effect of the BoNTA (6 weeks post injection). Resistance training consists of selected weighted exercises at 80% 0f 1 repetition max, repeated 5 days a week for 6 weeks with weight progressed weekly.
Intervention code [1] 2097 0
Treatment: Drugs
Intervention code [2] 2098 0
Rehabilitation
Comparator / control treatment
No Treatment
Control group
Active

Outcomes
Primary outcome [1] 3376 0
Melbourne Assessment of Unilateral Upper Limb Function
Timepoint [1] 3376 0
baseline, 6 weeks, 3 months and 6 months after randomisation
Secondary outcome [1] 5594 0
jerk analysis
Timepoint [1] 5594 0
baseline, 6 weeks, 3 months and 6 months after randomisation
Secondary outcome [2] 5595 0
Mapping of corticor motor pathways using transccranial magnetic stimuation
Timepoint [2] 5595 0
baseline, 6 weeks, 3 months and 6 months afetr randomisation

Eligibility
Key inclusion criteria
Age
hemiplegia due to cerebral palsy
spasticity
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
unable to complete all testing

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)
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation. Subjects were stratified to age within 6 months and within 10% of initial upper limb functional score as measured by the QUEST.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
4/07/2005
Date of last participant enrolment
Anticipated
Actual
3/10/2005
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 2625 0
Self funded/Unfunded
Name [1] 2625 0
Country [1] 2625 0
Australia
Primary sponsor type
Hospital
Name
Princess Margaret Hospital
Address
GPO Box D 184
Perth WA 6840
Country
Australia
Secondary sponsor category [1] 2374 0
University
Name [1] 2374 0
University of western australia
Address [1] 2374 0
School of Human Movement and exercise Science
Country [1] 2374 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4545 0
Princess Margaret Hospital
Ethics committee address [1] 4545 0
GPO Box D 184
Perth WA 6840
Ethics committee country [1] 4545 0
Australia
Date submitted for ethics approval [1] 4545 0
Approval date [1] 4545 0
21/04/2005
Ethics approval number [1] 4545 0
1127/EP

Summary
Brief summary
Objective: To investigate the impact on of conventional therapy and resistance therapy augmented with botulinum toxin A (BoNTA) in children with hemiplegic cerebral palsy (CP) on upper limb (UL) function and quality of movement. Assessment of movement quality was considered important, because early brain injuries are more susceptible to 'maladaptative' plasticity, which might result in abnormal movement behaviours.
Study Design: Single blind, randomised control trial (RCT) using matched pairs.
Methods: A control group continued with their usual community based ‘conventional’ therapy. The treatment group received either 1. BoNTA injections to the upper limb with conventional therapy or; 2. BoNTA injections to the upper limb with conventional therapy plus upper limb resistance training at the peak effect of the BoNTA.
Twenty-five participants aged between 8 and 16 years were enrolled. Assessments for this group included the Melbourne Assessment of Unilateral Upper Limb Function (MUUL); goal attainment using goal attainment scales (GAS) and kinematic analysis of reaching with the quantification of normalised jerk (NJ) reflecting movement fluency, and directness index (DI) reflecting movement efficiency. CNS changes were measured using Transcranial Magnetic Stimulation to map corticospinal pathways.
Results: GAS improved significantly in recipients who received resistance training augmented with BoNTA relative to controls at 1, 3 and 6 months (mean 58.1, SD 11.1, p<0.05). Therapy augmented with BoNTA resulted in improvements in movement fluency and efficiency and neuroplastic changes in some, but not all the children studied. The children who had preserved contralateral corticospinal pathways displayed less maladaptive movement behaviour with lower variability of NJ and DI, and higher MUUL score.
Conclusion: Augmenting physical therapies with BoNTA improves function, movement fluency and induces CNS changes in children with hemiplegic spastic CP. More significant gains in UL function were achieved in a shorter time when muscle resistance training was combined with BoNTA and maintained after the effect of the BoNTA had worn off.
Trial website
Trial related presentations / publications
Redman TA, Gibson N, Finn JC, Bremner AP, Valentine J, Thickbroom GW (2008) Upper limb corticomotor projections and physiological changes that occur with botulinum toxin-A therapy in children with hemiplegic cerebral palsy. EUROPEAN JOURNAL OF NEUROLOGY 15(8): 787-791 (Aug)
Public notes

Contacts
Principal investigator
Name 28055 0
Dr Noula Gibson
Address 28055 0
Physiotherapy Department
Princess Margaret Hospital for Children
Physiotherapy Department
PMH,
GPO Box D184,
Perth WA 6840
Country 28055 0
Australia
Phone 28055 0
+61 8 9340 8503
Fax 28055 0
Email 28055 0
[email protected]
Contact person for public queries
Name 11212 0
Dr Noula Gibson
Address 11212 0
GPO Box D 184
Perth WA 6840
Country 11212 0
Australia
Phone 11212 0
08 93408503
Fax 11212 0
08 9340 8001
Email 11212 0
[email protected]
Contact person for scientific queries
Name 2140 0
Dr Noula Gibson
Address 2140 0
GPO Box D 184
Perth WA 6840
Country 2140 0
Australia
Phone 2140 0
08 9340 8503
Fax 2140 0
08 9340 8001
Email 2140 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.