Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000912280
Ethics application status
Approved
Date submitted
16/10/2009
Date registered
21/10/2009
Date last updated
21/10/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
INCITE - a randomised trial of Novel upper limb rehabilitation in congenital hemiplegia
Scientific title
"A Randomised Trial Comparing Constraint Induced Movement Therapy and Bimanual Training on Upper Limb Function in Patients with Congenital Hemiplegia ".
Secondary ID [1] 1117 0
Nationa Health and Medical Research Council (NHMRC) 368500
Universal Trial Number (UTN)
Nil
Trial acronym
INCITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Hemiplegia 252018 0
Cerebral Palsy 252019 0
Condition category
Condition code
Neurological 252212 252212 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Constraint Induced movement therapy involves use of tailor made glove like splint worn on the unimpaired (dominant writting hand) and intensive activity based practice activities encouraging active use and manipulation with the other impaired (hemiplegic hand). Participants in the CIMT group will wear a tailor made glove on their unimpaired limb while attending the day camp, which will only be removed for toileting. The training occurs for 6 hours per day over 10 days for a total dose of 60 hours, with one trainer per two participants, in a comunity recreation facility.
Intervention code [1] 241421 0
Rehabilitation
Comparator / control treatment
Bimanual Training involves atcivity based practice with tasks that focus on equal use of both hands (both the unimpaired and the hemiplegic hand) in the task. The training occurs for 6 hours per day over 10 days for a total dose of 60 hours, with one trainer per two participants, in a comunity recreation facility.
Control group
Active

Outcomes
Primary outcome [1] 253081 0
Unimanual capacity for the hemiplegic limb measured on the Melbourne Unilateral Upper Limb Assessment
Timepoint [1] 253081 0
at 26 weeks post intervention
Secondary outcome [1] 257931 0
Bimanual Co-ordination on the Assisting Hand Assessment (AHA)
Timepoint [1] 257931 0
at 26 weeks post
Secondary outcome [2] 257932 0
Neuroplasticity determined on the Motor Evoked Potential (MEP) curves using Transcranial Magnetic Stimulation (TMS)
Timepoint [2] 257932 0
at 26 weeks post intervention
Secondary outcome [3] 257933 0
Community participation across borad domians on the Life Habits Questionnaire.
Timepoint [3] 257933 0
at 26 weeks post intervention
Secondary outcome [4] 257934 0
Quality of Life on the Cerebral Palsy Quality of Life Quesstionnaire (the CPQOL-Child Questionnaire).
Timepoint [4] 257934 0
at 26 weeks post intervetnion
Secondary outcome [5] 257935 0
Neurovascular changes in the primary motor cortex
Timepoint [5] 257935 0
at 26 weeks post intervention

Eligibility
Key inclusion criteria
Inclusion criteria
The study will include children and youth:
1. With a confirmed diagnosis of congenital hemiplegia.
2. Aged 5 to 16 years.
3. With predominant spasticity rather than dystonia interfering with upper limb function according to the classification of motor type by Sanger et al[31] with Modified Ashworth Scale grade >1 but <3.[32]
4. Ability to achieve minimal active grasp with the impaired hand.
5. Sufficient co-operation and cognitive understanding to participate in the group activities.
For a subset of children performing the Advanced Brain Imaging and Transcranial Magnetic Stimulation (TMS) studies further inclusion criteria are:-
1. Sufficient co-operation to perform Advanced Brain Imaging studies for 45 minutes.
2. No exclusions for 3 tesla Magnetic Resonance Imaging (3T MRI) including no metal implants, no shunts, no uncontrolled epilepsy as the later would be a confound.
3. For TMS there must be no current or previous history of epilepsy.
Minimum age
5 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Severe muscle spasticity and/or contracture on the Modified Ashworth Scale(MAS > grade 3, i.e. muscle contracture or rigidity) which would require spasticity management or serial casting.
2. Previous orthopaedic surgery in the upper limb.
3. Serial casting or Botulinum Toxin A (BoNT-A) injections in the upper limb within 6 months prior to study entry.

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 (12 month age bands), gender, side of hemiplegia, and level of functional ability based on Melbourne Unilateral Upper limb Assessment (MUUL) scores at screening. 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 (computer generated). The randomisation process will involve 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 the 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)
randomisation within pairs by computer number generation of 0 or 1 alternatives within the pairs
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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
1/04/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 243890 0
Government body
Name [1] 243890 0
National Health and Medical Research Institute
Country [1] 243890 0
Australia
Primary sponsor type
Government body
Name
National Health and Medical Research Insitute
Address
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country
Australia
Secondary sponsor category [1] 251235 0
Charities/Societies/Foundations
Name [1] 251235 0
Royal Childrens Hospital Foundation
Address [1] 251235 0
Royal Childrens Hospital Foundation,
Royal Childrens Hospital,
Herston rd.,
Herston. 4006
Country [1] 251235 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 244005 0
Royal Children?s Hospital and Health Services District
Ethics committee address [1] 244005 0
Department of Pediatrics and Child Health
3rd Floor, Foundation Building,
Royal Childrens Hospital,
Herston Rd.,
Herston. 4072
Ethics committee country [1] 244005 0
Australia
Date submitted for ethics approval [1] 244005 0
31/05/2008
Approval date [1] 244005 0
01/07/2008
Ethics approval number [1] 244005 0
HREC 2008/018
Ethics committee name [2] 244006 0
Royal Childrens Hospital, Melbourne
Ethics committee address [2] 244006 0
Ethics in Human Research Committee,
Ground Floor,
Royal Childrens Hospital,
Flemington Rd.,
Parkville. 3053
Victoria
Ethics committee country [2] 244006 0
Australia
Date submitted for ethics approval [2] 244006 0
01/02/2007
Approval date [2] 244006 0
01/03/2007
Ethics approval number [2] 244006 0
HREC 26074 A,B,C,D
Ethics committee name [3] 244007 0
University of Queensland
Ethics committee address [3] 244007 0
Medical Ethics Committee,
University of Queensland,
Research and Graduate Studies Office,
St Lucia, 4072.
Ethics committee country [3] 244007 0
Australia
Date submitted for ethics approval [3] 244007 0
01/07/2008
Approval date [3] 244007 0
01/08/2008
Ethics approval number [3] 244007 0
2008000961

Summary
Brief summary
This randomsied comparison trial will test the efficiacy of a novel rehabilitation (constraint induced movement therapy) whcih involves placing a glove on the unimpaired hand and intensively training the Hemiplegic hand and comparing this approach to more conventional bimanaul training in children with congenital hemiplegia.
Trial website
nil
Trial related presentations / publications
3. Gilmore R., Ziviani J, Sakzewski L., Boyd RN. A Clinimetric Review of Upper limb activity limitation measures. Developmental Medicine & Child Neurology. Accepted April 2009. (IF 2.433)
4. Sakzewski L, Ziviani J, Boyd RN. Efficacy of Non surgical interventions for congenital hemiplegia- Met analysis. Pediatrics, Accepted 30th Jan 2009. (IF= 4.473)
Public notes

Contacts
Principal investigator
Name 30393 0
Address 30393 0
Country 30393 0
Phone 30393 0
Fax 30393 0
Email 30393 0
Contact person for public queries
Name 13640 0
A/Professor Roslyn Boyd
Address 13640 0
Queensland Childrens Cerebral Palsy and Rehabilitation Research Centre
School of Medicine,
University of Queensland,
Royal Childrens Hospital,
herston rd., Herston. 4072
Country 13640 0
Australia
Phone 13640 0
+61 7 3365 5315
Fax 13640 0
+61 7 3365 5538
Email 13640 0
[email protected]
Contact person for scientific queries
Name 4568 0
A/Professor Roslyn Boyd
Address 4568 0
Queensland Childrens Cerebral Palsy and Rehabilitation Research Centre
School of Medicine,
University of Queensland,
Royal Childrens Hospital,
herston rd., Herston. 4072
Country 4568 0
Australia
Phone 4568 0
+61 7 3365 5315
Fax 4568 0
+61 7 3365 5538
Email 4568 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

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