Mitii™ 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).
BACKGROUND
Acquired brain injury (ABI) refers to multiple disabilities arising from damage to the brain acquired after birth. Children with an ABI may experience physical, cognitive, social and emotional-behavioural impairments which can impact their ability to participate in activities of daily living (ADL). Recent developments in technology have led to the emergence of internet-delivered therapy programs. "Move it to improve it" (Mitii™) is a web-based multi-modal therapy that comprises upper limb (UL) and cognitive training within the context of meaningful physical activity. The proposed study aims to compare the efficacy of Mitii™ to usual care to improve ADL motor and processing skills, gross motor capacity, UL and executive functioning in a randomised waitlist controlled trial.


METHODS
Sixty independently ambulant children (30 in each group) at least 12 months post ABI will be recruited to participate in this trial. Children will be matched in pairs at baseline and randomly allocated to receive either 20 weeks of Mitii™ training (30 min per day, six days a week, with a potential total dose of 60 h) immediately, or be waitlisted for 20 weeks. Outcomes will be assessed at baseline, immediately post-intervention and at 20 weeks post-intervention. The primary outcomes will be the Assessment of Motor and Process Skills and 30 s repetition maximum of functional strength exercises (sit-to-stand, step-ups and half kneel to stand). Measures of body structure and functions, activity, participation and quality of life will assess the efficacy of Mitii™ across all domains of the International Classification of Functioning, Disability and Health framework. A subset of children will undertake three tesla (3T) magnetic resonance imaging scans to evaluate functional neurovascular changes, structural imaging, diffusion imaging and resting state functional connectivity before and after intervention.


CONCLUSIONS
Mitii™ provides an alternative approach to deliver intensive therapy for children with an ABI in the convenience of the home environment. If Mitii™ is found to be effective, it may offer an accessible and inexpensive intervention option to increase therapy dose.


BACKGROUND
ANZCTR12613000403730.
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. r.boyd@uq.edu.au.
Roslyn N
RN
Boyd
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. e.baque@uq.edu.au.
Emmah
E
Baque
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. a.piovesana@uq.edu.au.
Adina
A
Piovesana
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. stephanie.ross@health.qld.gov.au.
Stephanie
S
Ross
Children's Allied Health Research, Children's Health Queensland, Brisbane, Queensland, Australia. j.ziviani@uq.edu.au.|School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Queensland, Australia. j.ziviani@uq.edu.au.
Jenny
J
Ziviani
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. l.sakzewski1@uq.edu.au.
Leanne
L
Sakzewski
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. l.barber@uq.edu.au.
Lee
L
Barber
Children's Allied Health Research, Children's Health Queensland, Brisbane, Queensland, Australia. Owen.Lloyd@health.qld.gov.au.
Owen
O
Lloyd
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. Lynne_McKinlay@health.qld.gov.au.|Children's Allied Health Research, Children's Health Queensland, Brisbane, Queensland, Australia. Lynne_McKinlay@health.qld.gov.au.
Lynne
L
McKinlay
Queensland Cerebral Palsy and Rehabilitation Research Centre, School of Medicine, The University of Queensland, Brisbane, Queensland, Australia. koawhittingham@uq.edu.au.
Koa
K
Whittingham
Centre for Online Health, The University of Queensland, Brisbane, Australia. asmith@uq.edu.au.
Anthony C
AC
Smith
CSIRO, ICT - Australian e-Health Research Centre, Royal Brisbane and Women's Hospital Centre for Clinical Research, The University of Queensland, Brisbane, Queensland, Australia. Stephen.Rose@csiro.au.
Stephen
S
Rose
Department of Developmental Neuroscience, IRCCS Stella Maris, Pisa, Italy. s.fiori@uq.edu.au.
Simona
S
Fiori
Queensland Brain Institute, The University of Queensland, Brisbane, Queensland, Australia. r.cunnington@uq.edu.au.|School of Psychology, The University of Queensland, Brisbane, Queensland, Australia. r.cunnington@uq.edu.au.
Ross
R
Cunnington
Queensland Children's Medical Research Institute, The University of Queensland, Brisbane, Queensland, Australia. r.ware@sph.uq.edu.au.|School of Population Health, The University of Queensland, Brisbane, Queensland, Australia. r.ware@sph.uq.edu.au.
Robert
R
Ware
Children's Allied Health Research, Children's Health Queensland, Brisbane, Queensland, Australia. melinda.lewis@health.qld.gov.au.
Melinda
M
Lewis
Griffith Health Institute and School of Medicine, Griffith University, Brisbane, Queensland, Australia. t.comans@griffith.edu.au.
Tracy A
TA
Comans
Griffith Health Institute and School of Medicine, Griffith University, Brisbane, Queensland, Australia. p.scuffham@griffith.edu.au.
Paul A
PA
Scuffham
D000293:Adolescent; D001921:Brain / Q000473:pathology; D001930:Brain Injuries / Q000534:rehabilitation*; D002648:Child; D003072:Cognition Disorders / Q000150:complications / Q000534:rehabilitation; D005081:Exercise Therapy / Q000379:methods; D005260:Female; D006801:Humans; D020407:Internet; D008279:Magnetic Resonance Imaging; D008297:Male; D009788:Occupational Therapy; D011788:Quality of Life; D012107:Research Design; D000069350:Telerehabilitation / Q000379:methods*; D016896:Treatment Outcome; D034941:Upper Extremity / Q000503:physiopathology; D014850:Waiting Lists