Abstract
BackgroundAcquired 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/DesignSixty 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.DiscussionMitii™ 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.Trial RegistrationANZCTR12613000403730Electronic supplementary materialThe online version of this article (doi:10.1186/s12883-015-0381-6) contains supplementary material, which is available to authorized users.
Highlights
Acquired brain injury (ABI) refers to multiple disabilities arising from damage to the brain acquired after birth
Despite the health benefits and recommended guidelines, Australian children at least one year post-ABI are 25-75 % less likely to participate at school, home and in the community compared to their peers and are at a higher risk of obesity and co-morbidities such as hypertension [34, 35]
MitiiTM will be more cost-effective compared with usual care as shown by resource use and consequence based on function (AMPS) and quality of life (QOL) (Child Health Utility 9D (CHU-9D) [60] and Kidscreen-52 [61])
Summary
This proposed study presents the background and design for a matched pairs, randomised waitlist controlled trial comparing 20 weeks of intensive MitiiTM training to usual care for children with an ABI. We will be evaluating outcomes of the MitiiTM training program across all domains of the ICF using the most valid and reliable assessment tools available for use. Additional file 1: MitiiTM ABI participant manual. Additional file 2: MitiiTM ABI rewards chart (child version). EB, ML, SR, and AP were responsible for data collection and implementation of the training program. RNB, SR and RC were responsible for design and implementation of the Advanced Brain Imaging outcomes. All authors contributed to the writing of this manuscript and have critically reviewed and approved the final version. EB will use the data from this study to contribute to her PhD thesis
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