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Trial registered on ANZCTR


Registration number
ACTRN12615000180516
Ethics application status
Approved
Date submitted
5/02/2015
Date registered
24/02/2015
Date last updated
26/08/2019
Date data sharing statement initially provided
26/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
REACH: Multisite randomised trial of Rehabilitation very EArly in Congenital Hemiplegia
Scientific title
Multisite randomised trial comparing infant-friendly modified constraint induced movement therapy and infant-friendly bimanual therapy to improve development of reach and grasp, fine motor skills and cognition for infants with asymmetric brain injuries.
Secondary ID [1] 286106 0
Nil
Universal Trial Number (UTN)
Trial acronym
REACH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asymmetric brain injury
294106 0
Cerebral palsy
294309 0
Congenital hemiplegia 294310 0
Condition category
Condition code
Neurological 294419 294419 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 294538 294538 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Infant-friendly modified constraint induced movement therapy (mCIMT) involves wearing a material glove/sock on the unimpaired hand to encourage use of the impaired hand in play based activity with the impaired arm/hand. mCIMT will be provided in the home by parents/caregivers to the infant by using the glove/sock and engaging the infant in specific play based activities. mCIMT will commence between 3-9 months corrected age, and be provided for 20 minutes per day (can be done in 2 by 10 minute blocks) for 5 days per week up to 6 months of age. Between 6 and 9 months of age, therapy will be provided for 30 minutes per day (can be done in 3 by 10 minute blocks) for 5 days per week.
Between 9 and 12 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Between 12 and 15 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Parents will be supported by an experienced occupational therapist/physiotherapist who do regular monthly home visits and fortnightly Skype calls for 6 months until the infant is 12-15 months of age to ensure that therapy is child and family friendly. Parents will document the intervention in a training log, and therapists will videorecord home visit therapy sessions.
Intervention code [1] 291102 0
Rehabilitation
Intervention code [2] 291203 0
Treatment: Other
Comparator / control treatment
Infant friendly BIManual therapy (BIM): comprises play-based activity designed to utilise equal activity of both the impaired and unimpaired upper limbs. BIM will be provided in the home by parents/caregivers to the infant by engaging the infant in age appropriate bimanual play activities. BIM will commence between 3-9 months corrected age, and be provided for 20 minutes per day (can be done in 2 by 10 minute blocks) for 5 days per week up to 6 months of age. Between 6 and 9 months of age, therapy will be provided for 30 minutes per day (can be done in 3 by 10 minute blocks) for 5 days per week. Between 9 and 12 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Between 12 and 15 months of age, therapy will be provided for 40 minutes per day (can be done in 2 by 20 minute blocks) for 5 days per week. Parents will be supported by an experienced occupational therapist/physiotherapist who do regular monthly home visits and fortnightly Skype calls for 6 months until the infant is 12-15 months of age to ensure that therapy is child and family friendly. Parents will document the intervention in a training log, and therapists will videorecord home visit therapy sessions.
Control group
Active

Outcomes
Primary outcome [1] 294216 0
Assisting Hand Assessment (Mini and Small Kids)
Timepoint [1] 294216 0
At post-intervention between 12-15 months-of-age (Mini AHA) and at 24 months-of-age (Small Kids AHA)
Primary outcome [2] 294217 0
Bayley Scales of Infant/Toddler Development (Bayley III)
Timepoint [2] 294217 0
At post-intervention between 12-15 months-of-age and at 24 months-of-age
Primary outcome [3] 294218 0
Hand Assessment of Infant
Timepoint [3] 294218 0
At study entry between 6-9 months-of-age and at post-intervention between 12-15 months-of-age
Secondary outcome [1] 312801 0
Pediatric Evaluation of Disability Inventory Computer Adapted Test (PEDI-CAT).
Timepoint [1] 312801 0
At post-intervention between 12-15 months-of-age and at 24 months-of-age
Secondary outcome [2] 312802 0
Emotional Availability-Self Report (EA-SR)
Timepoint [2] 312802 0
Baseline, at study entry between 6-9 months-of-age, at post-intervention between 12-15 months-of-age and 24 months-of-age,
Secondary outcome [3] 312803 0
Depression Anxiety Stress Scale (DASS-21)
The Maternal Infant Responsiveness Instrument and Maternal Postnatal Attachment Scale have been deleted as the attachment and responsiveness are measured in emotional availability using the Emotional Availability-Self Report.
Timepoint [3] 312803 0
Baseline, at study entry between 6-9 months-of-age, at post-intervention between 12-15 months-of-age and 24 months-of-age,
Secondary outcome [4] 312804 0
Diffusion MRI: Laterality index of mean diffusivity (MD) and fractional anisotropy (FA) of the cortico-spinal tracts.
Timepoint [4] 312804 0
2 years of age
Secondary outcome [5] 313020 0
Intervention Rating Scale (PRIME-G)
Timepoint [5] 313020 0
First home visit and at the midway point and end of the intervention.
Secondary outcome [6] 313021 0
Hammersmith Infant Neurological Examination (HINE)
Timepoint [6] 313021 0
At post-intervention between 12-15 months-of-age and 24 months-of-age

Eligibility
Key inclusion criteria
Participants will be recruited between 3 and 9 months corrected age (+14 days) and have English spoken in the family AND have the following by less than or equal to 9 months c.a:
1. Asymmetric brain lesion identified on CUS or MRI including asymmetric (one sided or more involved on one side) or unilateral brain injury including preterm or term arterial stroke, grade III or IV intraventricular haemorrhage, asymmetric periventricular leukomalacia or asymmetric deep grey matter (DGM) lesions; AND/OR
2 (a). Absent Fidgety Movements on General Movements Assessment at 12 weeks C.A. by direct video or uploaded using Baby Moves App (2 part consent for screening then recruitment) (including Asymmetric Fidgety whom are often later diagnosed with hemiplegia) AND/OR
2 (b). Abnormal Hammersmith Infant Neurological Examination (HINE) between 18 to 39 weeks AND
3. Asymmetry of upper limb reach and/or grasp on the Hand Assessment of Infants (> 3 point difference) that is congruent with the brain injury (opposite to likely side of the lesion)
In the absence of 1 participants must have 2(a) AND/OR 2(b). All participants must have 3.
Minimum age
3 Months
Maximum age
9 Months
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Epilepsy uncontrolled by medication as this would be a confounder.
2. Infants with Retinopathy of Prematurity (ROP) > grade 2 will be excluded.
3. Infants with Cortical blindness will be excluded.
4. Infants with ventriculo-peritoneal shunts will be excluded.
5. Asymmetric lesions that are NOT likely to be affecting the Corticospinal Tract (i.e. not affecting the Posterior Limb of the Internal Capsule or the Pyramids, or the motor cortex), such as tiny lesions of the cerebellum or the occipital pole, etc.

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)
150 infants with asymmetric brain lesions (identified on cranial ultrasound (CUS) or MRI prior to 12 weeks post term will be recruited and be aged between 3-9 months at study entry. These infants will be identified from neonatal follow-up in several tertiary centres: Lady Cilento Children's Hospital, Royal Brisbane and Women's Hospital, Mater Mothers Hospital, Sunshine Coast University Hospital and Gold Coast University Hospital in Queensland; CP Alliance, Westmead Hospital, Royal North Shore Hospital, Liverpool Hospital, Nepean Hospital, Royal Prince Alfred Hospital, Royal Women’s Hospital, St George Hospital, Blacktown Hospital, Campbelltown Hospital, John Hunter Children’s Hospital, Children's Hospital Randwick and Children’s Hospital at Westmead in Sydney; Royal Children's Hospital and Monash Medical Centre in Melbourne; Princess Margaret Hospital for Children and the King Edward Hospital for Women in Perth and the Australian Cerebral Palsy Register. An information sheet regarding the study will be circulated to therapists and treating clinicians to refer interested families. Potential study participants will be identified by treating clinicians, paediatricians, rehabilitation specialists, neonatologists and allied health professionals who would first contact the family and seek approval for the family to be contacted about the project. The referring clinician would then notify the researchers that they are able to contact the family about the study. Method of randomisation: central concealed random allocation using computer generated numbers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Children will be randomised centrally to receive either mCIMT or BIManual therapy using an electronic allocation system determined by non-study personnel.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The primary basis for sample size calculation is adequate power for H1 comparison between functional effects of mCIMT compared to BIManual therapy at 12 months c.a. Based on data from a study of 2-3 year olds (Eliasson et al., 2011) we propose a mean difference of 6 AHA logit points (100-Logit Scale) (Holmefur et al., 2009) as the minimum difference likely to have substantial clinical impact. Data from our large RCT comparing mCIMT and BIM in school-aged children with hemiplegia yielded SD of 12.8 and 12.6 in each group (Sakzewski et al, 2011). A sample size of 144 participants (72 per treatment) will have 80% power to detect 6 unit difference on AHA between groups (2-sided test at p<0.05). We require 150 children (75 in each group) to allow for attrition.

Standard principles for RCTs using two-group comparisons on all subjects on an intention-to-treat basis.

Recruitment
Recruitment status
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)
NSW,QLD,WA,VIC
Recruitment hospital [1] 3401 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [2] 3402 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 3405 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [4] 3406 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [5] 3407 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [6] 3408 0
King Edward Memorial Hospital - Subiaco
Recruitment hospital [7] 6792 0
Perth Children's Hospital - Nedlands
Recruitment hospital [8] 8855 0
Mater Mother's Hospital - South Brisbane
Recruitment hospital [9] 8856 0
Gold Coast University Hospital - Southport
Recruitment hospital [10] 8857 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [11] 8858 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [12] 8859 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [13] 8860 0
Liverpool Hospital - Liverpool
Recruitment hospital [14] 8861 0
Nepean Hospital - Kingswood
Recruitment hospital [15] 8862 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [16] 8863 0
St George Hospital - Kogarah
Recruitment hospital [17] 8864 0
Blacktown Hospital - Blacktown
Recruitment hospital [18] 8865 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [19] 8866 0
John Hunter Hospital - New Lambton
Recruitment hospital [20] 8867 0
Sydney Children's Hospital - Randwick
Recruitment hospital [21] 8868 0
Royal Hospital for Women - Randwick
Recruitment postcode(s) [1] 9184 0
4029 - Royal Brisbane Hospital
Recruitment postcode(s) [2] 9185 0
2145 - Westmead
Recruitment postcode(s) [3] 9187 0
3052 - Parkville
Recruitment postcode(s) [4] 9188 0
6008 - Subiaco
Recruitment postcode(s) [5] 9189 0
2086 - Frenchs Forest
Recruitment postcode(s) [6] 14448 0
6009 - Nedlands
Recruitment postcode(s) [7] 17081 0
4101 - South Brisbane
Recruitment postcode(s) [8] 17082 0
3168 - Clayton
Recruitment postcode(s) [9] 17083 0
4575 - Birtinya
Recruitment postcode(s) [10] 17084 0
2065 - St Leonards
Recruitment postcode(s) [11] 17085 0
2170 - Liverpool
Recruitment postcode(s) [12] 17086 0
2747 - Kingswood
Recruitment postcode(s) [13] 17087 0
2050 - Camperdown
Recruitment postcode(s) [14] 17088 0
2217 - Kogarah
Recruitment postcode(s) [15] 17089 0
2148 - Blacktown
Recruitment postcode(s) [16] 17090 0
2560 - Campbelltown
Recruitment postcode(s) [17] 17091 0
2305 - New Lambton
Recruitment postcode(s) [18] 17092 0
2031 - Randwick
Recruitment outside Australia
Country [1] 21810 0
United States of America
State/province [1] 21810 0
Ohio and Minnesota

Funding & Sponsors
Funding source category [1] 290692 0
Government body
Name [1] 290692 0
National Health and Medical Research Council of Australia
Address [1] 290692 0
National Health and Medical Research Council
GPO Box 1421
Canberra
ACT 2601
Country [1] 290692 0
Australia
Primary sponsor type
University
Name
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Address
Centre for Children's Health Research
62 Graham St
South Brisbane 4101
Queensland, Australia
Country
Australia
Secondary sponsor category [1] 289385 0
None
Name [1] 289385 0
Address [1] 289385 0
Country [1] 289385 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292326 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 292326 0
Centre for Children's Health Research
Level 7, 62 Graham Street
South Brisbane, Queensland, 4101
Ethics committee country [1] 292326 0
Australia
Date submitted for ethics approval [1] 292326 0
Approval date [1] 292326 0
15/12/2014
Ethics approval number [1] 292326 0
HREC/14/QRCH/376
Ethics committee name [2] 292327 0
The University of Queensland
Ethics committee address [2] 292327 0
Medical Ethics Committee
University of Queensland
research and Graduate Studies Office,
St Lucia,
QLD 4072
Ethics committee country [2] 292327 0
Australia
Date submitted for ethics approval [2] 292327 0
Approval date [2] 292327 0
16/01/2015
Ethics approval number [2] 292327 0
2015000013
Ethics committee name [3] 292328 0
Cerebral Palsy Alliance Ethics Committee
Ethics committee address [3] 292328 0
187 Allambie Rd, Allambie Heights, NSW 2100
PO Box 6427, Frenchs Forest, NSW 2086
Ethics committee country [3] 292328 0
Australia
Date submitted for ethics approval [3] 292328 0
20/01/2015
Approval date [3] 292328 0
05/11/2015
Ethics approval number [3] 292328 0
2015-01-02
Ethics committee name [4] 292329 0
Princess Margaret Hospital for Children Ethics Committee
Ethics committee address [4] 292329 0
Ethics Office
Princess Margaret Hospital for Children
GPO Box D184
PERTH WA 6840
Ethics committee country [4] 292329 0
Australia
Date submitted for ethics approval [4] 292329 0
03/02/2015
Approval date [4] 292329 0
24/06/2015
Ethics approval number [4] 292329 0
2015023EP
Ethics committee name [5] 294285 0
RCH Human Research Ethics Committee (HREC)
Ethics committee address [5] 294285 0
The Royal Children's Hospital
Level 4, South Building
50 Flemington Road
Parkville Victoria 3052
Ethics committee country [5] 294285 0
Australia
Date submitted for ethics approval [5] 294285 0
13/03/2015
Approval date [5] 294285 0
24/11/2015
Ethics approval number [5] 294285 0
SSA/15/RCHM/28
Ethics committee name [6] 304176 0
Office of the Vice President of Research - Institutional Review Board
Ethics committee address [6] 304176 0
200 Oak Street SE, Suite 350-2, Minneapolis, MN 55455
Ethics committee country [6] 304176 0
United States of America
Date submitted for ethics approval [6] 304176 0
21/11/2018
Approval date [6] 304176 0
24/01/2019
Ethics approval number [6] 304176 0
STUDY00005084
Ethics committee name [7] 304177 0
Office of Responsible Research Practices
Ethics committee address [7] 304177 0
300 Research Administration building
1960 Kenny Road
Columbus, OH 43210-1063
Ethics committee country [7] 304177 0
United States of America
Date submitted for ethics approval [7] 304177 0
21/12/2018
Approval date [7] 304177 0
18/01/2019
Ethics approval number [7] 304177 0
2018N0042 (OSU), NCH STUDY00000009

Summary
Brief summary
This multisite study will compare infant friendly modified constraint induced movement therapy to infant friendly bimanual therapy for infants with asymmetric brain injuries.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54650 0
Prof Roslyn Boyd
Address 54650 0
Queensland Cerebral Palsy and Rehabilitation Research Centre School of Medicine, University of Queensland
Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland 4101
Country 54650 0
Australia
Phone 54650 0
+61 7 3069 7372
Fax 54650 0
Email 54650 0
r.boyd@uq.edu.au
Contact person for public queries
Name 54651 0
Prof Roslyn Boyd
Address 54651 0
Queensland Cerebral Palsy and Rehabilitation Research Centre School of Medicine, University of Queensland
Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland 4101
Country 54651 0
Australia
Phone 54651 0
+61 7 3069 7372
Fax 54651 0
Email 54651 0
r.boyd@uq.edu.au
Contact person for scientific queries
Name 54652 0
Prof Roslyn Boyd
Address 54652 0
Queensland Cerebral Palsy and Rehabilitation Research Centre School of Medicine, University of Queensland
Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland 4101
Country 54652 0
Australia
Phone 54652 0
+61 7 3069 7372
Fax 54652 0
Email 54652 0
r.boyd@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
All data will be stored with an ID number on it and will not be made available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results