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Trial registered on ANZCTR


Registration number
ACTRN12613000181707
Ethics application status
Approved
Date submitted
13/02/2013
Date registered
15/02/2013
Date last updated
15/02/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
COMBiT- A randomised trial of combined constraint induced movement therapy and bimanual training in hemiplegia
Scientific title
COMBiT- randomised trial comparing combined constraint induced movement therapy and bimanual upper limb training to standard care consisting of an individualised therapy program for children with hemiplegia.
Secondary ID [1] 281947 0
Nil
Universal Trial Number (UTN)
Trial acronym
COMBiT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Hemiplegia
Cerebral Palsy
287800 0
Condition category
Condition code
Neurological 288151 288151 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
COMBiT is an intensive group based day program combining two theoretically different interventions: constraint induced movement therapy (CIMT) and bimanual upper limb training (BIM). CIMT upper limb training involves restraining the unimpaired limb using an individually tailored 'glove'combined with intense practice of tasks with the impaired limb during attendance at day camp. CIMT is performed first for 6 hours/day for 5 days=30 hours. This is followed by BIM which is based on motor learning and requires individualised 2 handed activities. This will be performed in the second week 6 hours/day for 5 day=30 hours. COMBiT will use a circus based theme for the day camp. The CIMT and BIM interventions will be conducted in a group based format faciliated by experienced occupational therapists and circus trainers.
Intervention code [1] 286049 0
Rehabilitation
Comparator / control treatment
COMBiT intensive therapy will be compared to standard therapy which involves individually tailored therapy 2 hours/week for 6 weeks, in addition to a home program of 30 minutes a day for 6 days/week for 12 weeks. Standard care therapy will be conducted by experienced occupational therapists in a one on one sessions for the duration of the six week program. The occupational therapists will formulate the home program in consultation with the child's parent to target the child's individual upper limb functional goals. The parent ensures the home program is completed with regular contact with the occupational therapist.
Control group
Active

Outcomes
Primary outcome [1] 288358 0
Bimanual Coordination on the Assisting Hand Assessment (AHA)
Timepoint [1] 288358 0
12 weeks post intervention
26 weeks post intervention
Primary outcome [2] 288361 0
Unimanual capacity for the hemiplegic limb measured on the Melbourne Unilateral Upper Limb Assessment (MUUL)
Timepoint [2] 288361 0
12 weeks post intervention
26 weeks post intervention
Secondary outcome [1] 299948 0
Participation using individualised goals will be measured using the Canadian Occupational Performance Measure (COPM).
Timepoint [1] 299948 0
12 weeks post intervention
26 weeks post intervention

Eligibility
Key inclusion criteria
Participants will have reduced upper limb (UL) function due to predominant spasticity rather than dystonia, and sufficient cognitive capacity to follow instructions and participate in the UL intervention. The study will include school aged children and youth:
1. Confirmed diagnosis of congential hemiplegia
2. Aged 5-16 years
3. Reduced upper limb function due to predominant spasticity rather than dystonia
4. Sufficient cooperation and cognitive understanding to particiapte in the therapy activities.
Minimum age
5 Years
Maximum age
16 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have:
1. Fixed contracture or severe muscle spasticity in the designated muscle groups
2. Previously undergone surgery in the UL
3. Received BoNT-A injections within 6 weeks prior to baseline assessments.

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)
Children will be matched in pairs according to age, gender, and side of hemiplegia. Once matching has been achieved and baseline assessments completed, children will be randomised within pairs from concealed envelopes opened by non study personnel. Treatment allocation will be recorded on a piece of folded paper inside each envelope in random order. The randomisation process will involved allocating a number '1' or '2' to each member of the pair which will be written on the paper inside the envelope. As each pair is entered, they will be allocated the next consecutive envelope, which will be opened by non study personnel who will read and record the treatment allocation from the paper inside the envelope. Study personnel will be informed of group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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)
QLD
Recruitment hospital [1] 598 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 6346 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286318 0
Government body
Name [1] 286318 0
National Health and Medical Research Council
Address [1] 286318 0
National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
Country [1] 286318 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Council
Address
National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
Country
Australia
Secondary sponsor category [1] 285104 0
None
Name [1] 285104 0
Address [1] 285104 0
Country [1] 285104 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288388 0
Children's Health Services- Royal Children's Hospital
Ethics committee address [1] 288388 0
Department of Paediatrics and Child Health
3rd Floor, Foundation Building,
Royal Childrens Hospital
Herston Rd
Herston
QLD 4006
Ethics committee country [1] 288388 0
Australia
Date submitted for ethics approval [1] 288388 0
Approval date [1] 288388 0
29/04/2011
Ethics approval number [1] 288388 0
HREC/11/QRCH/37
Ethics committee name [2] 288390 0
University of Queensland
Ethics committee address [2] 288390 0
Medical Ethics Commitee
University of Queensland
research and Graduate Studies Office,
St Lucia,
QLD 4072
Ethics committee country [2] 288390 0
Australia
Date submitted for ethics approval [2] 288390 0
Approval date [2] 288390 0
10/05/2011
Ethics approval number [2] 288390 0
2011000553

Summary
Brief summary
This research project will compare a new intensive upper limb rehabilitation approach (COMBiT- combined constraint induced movement therapy and bimanual therapy) with standard care individual occupational therapy for children with congenital hemiplegia.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34948 0
Prof Roslyn Boyd
Address 34948 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
School of Medicine,
University of Queensland
Royal Brisbane and Women's Hospital
Level 7, Block 6
Butterfield St
Herston
QLD 4029
Country 34948 0
Australia
Phone 34948 0
+61 7 3646 5542
Fax 34948 0
Email 34948 0
r.boyd@uq.edu.au
Contact person for public queries
Name 18195 0
Prof Roslyn Boyd
Address 18195 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
School of Medicine,
University of Queensland
Royal Brisbane and Women's Hospital
Level 7, Block 6
Butterfield St
Herston
QLD 4029
Country 18195 0
Australia
Phone 18195 0
+61 7 3646 5542
Fax 18195 0
Email 18195 0
r.boyd@uq.edu.au
Contact person for scientific queries
Name 9123 0
Prof Roslyn Boyd
Address 9123 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
School of Medicine,
University of Queensland
Royal Brisbane and Women's Hospital
Level 7, Block 6
Butterfield St
Herston
QLD 4029
Country 9123 0
Australia
Phone 9123 0
+61 7 3646 5542
Fax 9123 0
Email 9123 0
r.boyd@uq.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary