Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000403730
Ethics application status
Approved
Date submitted
9/04/2013
Date registered
12/04/2013
Date last updated
12/04/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Mitii ABI: "Move it to improve it": A randomised trial of novel web-based intervention for children with acquired brain injury.
Scientific title
A randomised control trial evaluating the Mitii (Move it to improve it) program, compared to standard care, to improve functional, neurological and participation outcomes for children with acquired brain injuries (8-16 years).
Secondary ID [1] 282204 0
Nil
Universal Trial Number (UTN)
Trial acronym
Mitii ABI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 288723 0
Condition category
Condition code
Neurological 289077 289077 0 0
Other neurological disorders

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 (UL) 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 in a virtual training environment.
The program is potentially cost effective as only 3 center based therapists (occupational therapist, physiotherapist, neuropsychologist) are required to provide initial assessment, goal setting and training for families and participating children. Each therapist is then able to remotely moditfy the individualised program each week. The current application proposes to test the efficacy of Mitii in a waitlist randomised controlled trial.
We propose to provide Mitii at an intensity of 30 minutes per day for 6 days per week over 20 weeks (total dose 60 hours). All children will therefore receive the therapy within 12 months of being randomised either to commence Mitii immediately or after 5 months, with retention of effects tested at 40 weeks.
As current therapy programs are resource intensive and time consuming it its important to determine if gains from Mitii are sustained as this could offer a cost effective model of care, particularly for rural, remote and isolated children with acquired brain injuries.
Intervention code [1] 286820 0
Rehabilitation
Comparator / control treatment
Standard treatment/Care as usual: Waitlist control group will receive Standard treatment/Care as usual until month 5, at which time they will be offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 289188 0
Improvement in 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] 289188 0
Baseline, Immediately post-intervention and retention 20 weeks post intervention
Secondary outcome [1] 301979 0
Improvement in Activity limitations (unimanual capacity and bimanual performance) by a mean difference of 5 points on the Assisting Hand Assessment (AHA) and 7.4% or greater on the Melbourne Assessment Unilateral Upper Limb function (MUUL), a 10% decrease in time on the Jebsen-Taylor Test of Hand Function (JTTHF).
Timepoint [1] 301979 0
Baseline, immediately post intervention and retention at 20 weeks post intervention.
Secondary outcome [2] 301980 0
Improvement in neurovascular changes as measured on functional magnetic resonance imaging [fMRI] will be more extensive and retained for a longer.
Timepoint [2] 301980 0
Baseline and immediately post intervention
Secondary outcome [3] 301981 0
Improvment in visual perception (visual discrimination, visual memory and visual sequential memory) as measured by the Test of Visual Perceptual Skills (TVPS).
Timepoint [3] 301981 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [4] 301982 0
Improvements in Executive functioning (EF: including information processing, attentional control, cognitive flexibility, goal setting, working memory and behavioural manifestations of EF in everyday life - BRIEF).
Timepoint [4] 301982 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [5] 301983 0
Improvements in Psychological functioning as measured on the Strength and difficulties Quesstionnaire (SDQ).
Timepoint [5] 301983 0
Baseline, immediately post intervention and retention at 20 weeks post intervention.
Secondary outcome [6] 301984 0
Improvements in participation (as measured on the Child and Adolescent Scale of Participation, The Child and Family Follow up Survey)which indicates the extent of participation in important activities at home, school and community environments (PEM-CY).
Timepoint [6] 301984 0
Baseline, immediately post intervention and retention at 20 weeks post intervention.
Secondary outcome [7] 301985 0
Improvements in Occupational performance (as measured on the Canadian Occupational Performance Measure, COPM performance and satisfaction)
Timepoint [7] 301985 0
Baseline, immediately post intervention and retention at 20 weeks post intervention.
Secondary outcome [8] 301994 0
Improvements in the functioning and participation domains of quality of life (on the Kidscreen-52 Quesstionnaire);
Timepoint [8] 301994 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [9] 301995 0
Improvements on the functional abilities in self care and daily activities (MobQues47 Questionnaire);
Timepoint [9] 301995 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [10] 301996 0
Improvements in physical activity capacity immediately following Mitii training (Functional strength: half kneel through stand, sit to stand and step up tests; and Six-minute fast walk test, high level balance and mobility - HiMAT) and the Timed Up and Go Test (TUG).
Timepoint [10] 301996 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [11] 301997 0
Improvements in physical activity performance (recorded using the ActiGraph) and greater compliance with the Australian National Physical Activity Guidelines.
Timepoint [11] 301997 0
Baseline, immediately post intervention and retention at 20 weeks post intervention
Secondary outcome [12] 301998 0
Mitii will be more cost-effective compared with Usual Care as shown by resource use and consequence based on function (AMPs) and quality of life (CHU-9D/Kidscreen52).
Timepoint [12] 301998 0
Baseline, immediately post intervention and retained at 20 weeks post intervention

Eligibility
Key inclusion criteria
i. Sufficient cooperation, cognitive understanding, visual acuity and verbal communication to perform the assessments and intervention;
ii. Minimum 12 months since most recent head injury sustained;
iii. Equivalent GMFCS I to II
and MACS I to III;
(ie independently ambulate and handle most types of objects
independently)
iv. Classification of Moderate (Glasgow Coma Scale (GCS) score 9 to12
and/or neurosurgical intervention) or
Severe (GCS score <9 and/or neurosurgical intervention) brain injury.
v. Able to participate in the study over a 12 month period (i.e. stable homeenvironment)
vi. Screened for eligibility by rehabilitation specialist
vii.The child will be considered for the study if the child had a physical impairment following brain injury and now
presents with a residual physical impairment (e.g. may only be mild fine motor or high level gross motor, or motor
processing difficulties).
Minimum age
8 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i. Unstable brain injury (e.g degenerative or metabolic conditions)
ii. Unstable epilepsy (frequent seizures uncontrolled by medication)
iii. Have undergone active medical treatment (e.g. radiation or chemotherapy) in past 6 months
iv. Have undergone any surgical intervention e.g. orthopaedic or neurosurgical in the past 6 months. Children who
have received intramuscular Botulinium Toxin Type A injections will have entry delayed by 1 month after completion of standard care.
v. No physical impairment following their brain injury.

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 (18 month age bands), and intellectual functioning (>80 or <80. Where available, an IQ assessment which has been completed >12 months post injury can be used, otherwise an IQ assessment will be completed prior to matching.). A matched pairs design is the design of choice as it minimises the likelihood of group differences at baseline that has often been present in rehabilitation studies. Once matching has been achieved, children will be randomised within pairs (one member of each pair to randomly allocated to each group) 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 (either 1:Waitlist 2:Immediate; or 1:Immediate 2:Waitlist, with the sequence being computer generated). The randomisation process will involve allocating a number “1” or “2’ to each member of the pair. 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)
Once matching has been achieved, children will be randomised within pairs (one member of each pair to randomly allocated to each group) 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 (either 1:Waitlist 2:Immediate; or 1:Immediate 2:Waitlist, with the sequence being computer generated). The randomisation process will involve allocating a number “1” or “2’ to each member of the pair. 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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Wait list cotrol group where the standard treatment/ care as usual group will receive standard treatment until month 5, at whcih time they will be offered the intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For sample size determination if we are planning a study with 30 experimental subjects and 30 control subjects. In a previous study the response within each subject group was normally distributed with standard deviation 0.39. If the true difference in the experimental and control means is 0.35, we will be able to reject the null hypothesis that the population means of the experimental and control groups are equal with probability (power) .790. The Type I error probability associated with this test of this null hypothesis is 0.05. Analysis will follow standard principles for RCTs, using two-group comparisons on all participants on an intention-to-treat basis. External and internal validity of results will be checked using baseline and general descriptive information available for all eligible families; comparing the characteristics of families who completed the study with those who enrolled in the study but did not complete, and those who did not enrol. The primary comparison immediately post intervention (20 weeks) will be the AMPS and AHA scores. Outcomes between treatment groups will be compared at follow-up using generalised estimating equations (GEEs), with time (0, 20, 40 weeks) and study group (Mitii, usual care), as well as a time by group interaction as covariables. We will use the Gaussian family, identity link, and an exchangeable correlation structure. Secondary analyses will compare the outcomes between groups for participation (domains of LIFE-H) and QOL (domains of Kidscreen52). For dichotomous outcomes we will compare outcomes between-group outcomes using GEEs with the logistic family and logit link. For continuous variables we shall compare using the Gaussian family and identity link (possibly after transformation, depending on the distribution). Statistical significance will be at p<0.05 with adjustment for multiple comparisons, and all analyses will be intention to treat. Sensitivity analyses using imputation techniques will investigate whether the effect estimates are biased as a consequence of non-ignorable missing data.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
22/04/2013
Actual
22/04/2013
Date of last participant enrolment
Anticipated
30/06/2014
Actual
25/11/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 815 0
Royal Children's Hospital - Herston
Recruitment postcode(s) [1] 6634 0
4029 - Royal Brisbane Hospital

Funding & Sponsors
Funding source category [1] 286969 0
Government body
Name [1] 286969 0
Queensland Department of Innovation - E Brain Program Grant
Country [1] 286969 0
Australia
Funding source category [2] 287048 0
Charities/Societies/Foundations
Name [2] 287048 0
Perpetual Trustees Pty Ltd
Country [2] 287048 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Medicine
University of Queensland
St Lucia,
QLD 4072
Country
Australia
Secondary sponsor category [1] 285833 0
None
Name [1] 285833 0
Address [1] 285833 0
Country [1] 285833 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289017 0
Children's Health Services Queensland Human Research Ethics Committee
Ethics committee address [1] 289017 0
Department of Pediatrics and child health
3rd floor, Foundation building
Royal Children's Hospital
Herston Rd.,
Herston
QLD 4029
Ethics committee country [1] 289017 0
Australia
Date submitted for ethics approval [1] 289017 0
11/12/2012
Approval date [1] 289017 0
17/12/2012
Ethics approval number [1] 289017 0
HREC/12/QRCH/222
Ethics committee name [2] 289018 0
University of Queensland
Ethics committee address [2] 289018 0
Medical Ethics Committee
University of Queensland
Research and Graduate Studies Office
St Lucia
QLD 4072
Ethics committee country [2] 289018 0
Australia
Date submitted for ethics approval [2] 289018 0
21/02/2013
Approval date [2] 289018 0
27/02/2013
Ethics approval number [2] 289018 0
2013000212

Summary
Brief summary
This randomized comparison trial will test the efficacy of a novel rehabilitation (Move it to improve it' (MiTii) which involves the use of a web based, intensive, individualized, multi-modal therapy program with therapists acting as virtual trainers, over a 20 week period, and comparing this approach to standard care received in children with acquired brain injury.
Trial website
http://www.som.uq.edu.au/research/research-centres/cerebral-palsy-and-rehabilitation-research-centre.aspx
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 38814 0
Prof Roslyn Boyd
Address 38814 0
Queensland Cerebral Palsy and Rehabilitation Research Centre
School of Medicine, Department of Paediatrics,The University of Queensland
Level 3 Foundation Building, Royal Children's Hospital,
Herston Rd.,
Herston, QLD, 4029
Country 38814 0
Australia
Phone 38814 0
+61 7 33655315
Fax 38814 0
Email 38814 0
[email protected]
Contact person for public queries
Name 38815 0
Prof Roslyn Boyd
Address 38815 0
Queensland Cerebral Palsy Research and Rehabilitation Centre
School of Medicine, Department of Paediatrics, The University of Queensland
Level 3 Foundation Building, Royal Children's Hospital, Herston Rd.,
Herston, QLD, 4029
Country 38815 0
Australia
Phone 38815 0
+61 7 33655315
Fax 38815 0
Email 38815 0
[email protected]
Contact person for scientific queries
Name 38816 0
Prof Roslyn Boyd
Address 38816 0
Queensland Cerebral Palsy Research and Rehabilitation Centre
School of Medicine, Department of Paediatrics, The University of Queensland
Level 3 Foundation Building, Royal Children's Hospital
Herston Rd., Herston, QLD, 4029
Country 38816 0
Australia
Phone 38816 0
+61 7 33655315
Fax 38816 0
Email 38816 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
SourceTitleYear of PublicationDOI
EmbaseMitiiTM ABI: Study protocol of a randomised controlled trial of a web-based multi-modal training program for children and adolescents with an Acquired Brain Injury (ABI).2015https://dx.doi.org/10.1186/s12883-015-0381-6
N.B. These documents automatically identified may not have been verified by the study sponsor.