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Trial registered on ANZCTR


Registration number
ACTRN12611001174976
Ethics application status
Approved
Date submitted
11/07/2011
Date registered
10/11/2011
Date last updated
3/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
MiTii: A randomised trial of novel web-based upper limb intervention for congenital hemiplegia
Scientific title
A randomised control trial evaluating the functional, neurological and participation outcomes of the "Move it To improve it" program for children with congenital Hemiplegia
Secondary ID [1] 259819 0
Nil
Universal Trial Number (UTN)
Trial acronym
MiTii
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Hemiplegia
Cerebral Palsy
265398 0
Condition category
Condition code
Neurological 265554 265554 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 270985 270985 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
MiTii (“Move it To improve it”) is an internet-based multimodal therapy which combines upper-limb training within the context of meaningful physical activity that can be accessed in children's homes. Inherent in this approach is the ability to scaffold visual perception skills and cognitive challenge, both important aspects of activity engagement and participation in a virtual training environment. The program is potentially cost effective as only three centre-based therapists (Physiotherapist, Occupation Therapist, and psychologist) are required to provide initial assessment, goal setting and training for families and participating children. Each therapist then spends 30 minutes each week to remotely modify the individualised program. This current application proposes to test the efficacy of MiTii in a wait list randomised controlled trial. We propose to provide MiTii at an intensity of 30 minutes per day, 6 days/week for 20 weeks (total dose 60 hours). All children will therefore receive the therapy within 10 months of being randomised either to commence MiTii immediately or waitlisted for 20 weeks before receiving the same Mitii therapy as the Immediate invention group. Retention of effects will be tested at 10 months. As current therapy programs are resource intensive and time consuming it is important to determine if gains from MiTii are sustained over a 10 month period as this could offer a cost effective model of care, particularly for rural, remote and isolated children with CP.
Intervention code [1] 264247 0
Rehabilitation
Comparator / control treatment
The delayed intervention or waitlist group will act as a control group. These children will undergo baseline assessment and then be sent home for 20 weeks receiving standard Treatment/Care as Usual. After the 20 weeks, assessments will be repeated and they will then receive the same 20 week Mitii training as the Immediate Intervention group. Standard care is considered Physiotherapy, Occupational Therapy or Psychology that the child would otherwise receive without the intervention, excluding splinting, casting or surgery management. Should children normally received Botox, their inclusion in the study will be delayed until after their Botox and standard follow up care has been completed. Standard care will be assessed using a parent questionnaire which documents the types of therapies and frequency received
Control group
Active

Outcomes
Primary outcome [1] 262360 0
Motor and Process Skills in daily living activities as demonstrated by a 0.5 logit score on the Assessment of Motor and Process Skills (AMPS)
Timepoint [1] 262360 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement
Secondary outcome [1] 273625 0
Activity limitations (unimanual capacity and bimanual performance) by mean difference of 5 points on the Assisting Hand Assessment (AHA) and 10% decrease in time on the Jebsen-Taylor Test of Hand Function (JTHF)
Timepoint [1] 273625 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [2] 273626 0
Neuroplasticity determined on the Motor Evoked Potential (MEP) curves using Transcranial Magnetic Stimulation (TMS)
Timepoint [2] 273626 0
immediately post-intervention (at 20 weeks) and retained at 40weeks post intervention commencement.
Secondary outcome [3] 273627 0
Visual perception (visual discrimination, visual memory and visual sequential memory)
Timepoint [3] 273627 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [4] 273628 0
Executive functioning (sustained attention, working memory and cognitive flexibility)
Timepoint [4] 273628 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [5] 273629 0
Executive functioning in everyday life (measured by the BRIEF)
Timepoint [5] 273629 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [6] 273630 0
Participation (LIFE-H) by 0.5 weighted score for categories of personal care, nutrition, education and recreation
Timepoint [6] 273630 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [7] 273631 0
Occupational performance (COPM performance and satisfaction) by 2 points
Timepoint [7] 273631 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [8] 273632 0
Functioning and participation domains of quality of life (CP-QOL-child/CP-QOL-Teen) by 5 points on specified domains
Timepoint [8] 273632 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [9] 273633 0
MiTii will be more cost-effective compared with Usual Care as shown by resource use and effectiveness based on function (AMPs) and quality of life (CPQOL)
Timepoint [9] 273633 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.
Secondary outcome [10] 279074 0
MiTii will increase physical activity capability (measured using the functional strength assessments, walking tests and modified shuttle run test) and performance (measured using a physical activity questionnaire and accelerometers over >3 days)
Timepoint [10] 279074 0
immediately post-intervention (at 20 weeks) and retained at 40 weeks post intervention commencement.

Eligibility
Key inclusion criteria
i. Gross Motor Function Classification (GMFCS) I or II; Manual Abilities (MACs) I, II, III. ii. Sufficient co-operation and cognitive understanding to perform the tasks and access the computer equipment; iii. Are able to attend 3 appointments in Brisbane for initial assessment/training and follow-up assessments. iv. Able to access the internet at home (phone line or internet access). Note; laptops will be loaned for those require them and camera’s provided for all children with the treatment phase.
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. received upper limb surgery in the last 6mths; ii. unstable epilepsy (i.e. not controlled by medication) is a precaution for TMS. Where children have received BoNT-A or upper limb casting in the previous 1 month, inclusion in the study will be delayed until after treatment and standard follow up.

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)
Screening phone call to ensure participant's suitability. Rolling recruitment in blocks of 10-15 children. Matching pairs for age/gender/MACS scores Once baseline assessments have been 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 1 or 2 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
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] 264710 0
Government body
Name [1] 264710 0
National Health and Medical Research Council (applied March 2011)
Address [1] 264710 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 264710 0
Australia
Funding source category [2] 267413 0
Charities/Societies/Foundations
Name [2] 267413 0
Royal Childrens Hospital Foundation
Address [2] 267413 0
Foundation Building
Royal Childrens Hospital
Herston Road
Herston
Qld
4029
Country [2] 267413 0
Australia
Primary sponsor type
Government body
Name
Smart Futures Coinvestment Fund
Address
Queensland Government
Country
Australia
Secondary sponsor category [1] 263841 0
Charities/Societies/Foundations
Name [1] 263841 0
Foundation for Children
Address [1] 263841 0
Foundation for Children
GPO Box 3655
Sydney NSW 2000
Country [1] 263841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266692 0
Royal Childrens Hospital and Health Services District
Ethics committee address [1] 266692 0
Department of Pediatrics and Child Health
3rd Floor, Foundation Building,
Royal Childrens Hospital,
Herston Rd,
Herston
QLD 4029
Ethics committee country [1] 266692 0
Australia
Date submitted for ethics approval [1] 266692 0
26/03/2011
Approval date [1] 266692 0
23/06/2011
Ethics approval number [1] 266692 0
HREC/11/QRCH/35
Ethics committee name [2] 266693 0
University of Queensland
Ethics committee address [2] 266693 0
Medical Ethics Committee,
University of Queensland,
Research and Graduate Studies Office,
St Lucia,
QLD 4072
Ethics committee country [2] 266693 0
Australia
Date submitted for ethics approval [2] 266693 0
26/03/2011
Approval date [2] 266693 0
25/05/2011
Ethics approval number [2] 266693 0
UQ 2011000608

Summary
Brief summary
This randomized comparison trial will test the efficacy of a novel rehabilitation (MiTii: Move it To improve it) which involves the use of a web-based, intensive and individualized, multimodal therapy program with therapists acting as 'virtual trainers', over a 20 week period, and comparing this approach to standard care received in children with congenital hemiplegia.
Trial website
Nil
Trial related presentations / publications
Nil
Public notes

Contacts
Principal investigator
Name 32361 0
Prof Roslyn Boyd
Address 32361 0
Queensland Childrens Cerebral Palsy and Rehabilitation Research Centre School of Medicine, Department of Paediatrics, University of Queensland, Level 7, Block 6, Royal brisbane And Women's Hospital Bowen bridge Road Herston, QLD, 4029
Country 32361 0
Australia
Phone 32361 0
+6173365 5315
Fax 32361 0
+6173365 5538
Email 32361 0
r.boyd@uq.edu.au
Contact person for public queries
Name 15608 0
Prof Roslyn Boyd
Address 15608 0
Queensland Childrens Cerebral Palsy and Rehabilitation Research Centre
School of Medicine, Department of Paediatrics, University of Queensland,
Level 7, Block 6,
Royal brisbane And Women's Hospital
Bowen bridge Road
Herston, QLD, 4029
Country 15608 0
Australia
Phone 15608 0
+617 3365 5315
Fax 15608 0
+6173365 5538
Email 15608 0
r.boyd@uq.edu.au
Contact person for scientific queries
Name 6536 0
Prof Roslyn Boyd
Address 6536 0
Queensland Childrens Cerebral Palsy and Rehabilitation Research Centre
School of Medicine, Department of Paediatrics, University of Queensland,
Level 7, Block 6,
Royal brisbane And Women's Hospital
Bowen bridge Road
Herston, QLD, 4029
Country 6536 0
Australia
Phone 6536 0
+6173365 5315
Fax 6536 0
+6173365 5538
Email 6536 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