Introduction The STRoke Interactive Virtual thErapy (STRIVE) intervention provides community-dwelling stroke survivors access to individualised, remotely supervised progressive exercise training via an online platform. This trial aims to determine the clinical efficacy of the STRIVE intervention and its effect on brain activity in community-dwelling stroke survivors.
Methods and analysis In a multisite, assessor-blinded randomised controlled trial, 60 stroke survivors >3 months poststroke with mild-to-moderate upper extremity impairment will be recruited and equally randomised by location (Melbourne, Victoria or Launceston, Tasmania) to receive 8 weeks of virtual therapy (VT) at a local exercise training facility or usual care. Participants allocated to VT will perform 3–5 upper limb exercises individualised to their impairment severity and preference, while participants allocated to usual care will be asked to maintain their usual daily activities. The primary outcome measures will be upper limb motor function and impairment, which will be assessed using the Action Research Arm Test and Upper Extremity Fugl-Meyer, respectively. Secondary outcome measures include upper extremity function and spasticity, as measured by the box and block test and Modified AshworthScale, respectively, and task-related changes in bilateral sensorimotor cortex haemodynamics during hand reaching and wrist extension movements as measured by functional near-infrared spectroscopy. Quality of life will be measured using the Euro-Quality of Life-5 Dimension-5 Level Scale, and the Motor Activity Log-28 will be used to measure use of the hemiparetic arm. All measures will be assessed at baseline and immediately postintervention.
Ethics and dissemination The study was approved by the Deakin University Human Research Ethics Committee in May 2017 (No. 2017–087). The results will be disseminated in peer-reviewed journals and presented at major international stroke meetings.
Trial registration number ACTRN12617000745347; Pre-results.
Stroke is one of the leading causes of adult disability in Western countries,1 and for many stroke survivors, upper extremity (UE) paresis makes performing activities of daily living (ADLs) difficult. Up to 60% of community-dwelling stroke survivors live with severe motor impairments of the shoulders, elbows and/or wrists that significantly impacts their functional capacity and quality of life.2 Improved UE function is considered a rehabilitation priority after stroke,3 yet optimal recovery of arm function is poor.2 4 A large majority of stroke survivors experience a lack of support and access to rehabilitative services once they are discharged into the community,5 6 which can compromise their recovery. While most recovery occurs in the first weeks to months after stroke, improvements in function can still be experienced beyond this period.7
The use of virtual reality as a therapy, which is characterised by the participant being immersed in, and interacting with, a computer-generated environment,8 is emerging as an efficacious treatment for UE impairment after stroke.9 10 Online virtual therapy (VT) systems can provide the fundamental elements needed for motor skill development; they can be individually tailored, involve many task-specific repetitions that are increasingly challenging in response to participant improvement and feedback can be embedded in the system. The enriched environment offered by VT is thought to be effective in training problem solving and functional task performance11 and can potentially increase participant engagement compared with non-VT rehabilitation platforms.12
Online VT systems have the potential to address the lack of community-based rehabilitation support experienced by stroke survivors by being affordable, accessible, user-friendly and importantly, have the ability to remotely monitor rehabilitation progress. VT systems, such as the Jintronix Rehabilitation System (Montreal, Canada) to be used in this study, can be administered affordably through commercially available products that include motion capture capabilities (eg, Microsoft Xbox Kinect V.2) and personal computers.13 Online VT systems can be easily implemented at a local community centre, which would enable patients with stroke to receive specialised treatment and monitoring remotely. Online VT platforms have been shown to be user-friendly and motivating,14 including interfaces that are engaging and easy to interact with, and software that can be run on any personal computer/device. In a Cochrane review, Laver et al 9 reported low-quality evidence suggesting VT is a more effective approach to improve arm function after stroke compared with conventional therapy.9 A recent multiple systematic review, including 10 randomised controlled trials and four systematic reviews, found VT therapy to be similar to standard rehabilitation for treatment of UE impairment and disabilities.15
To understand the effects of VT on cerebral activity in stroke rehabilitation, neuroimaging techniques such as functional MRI (fMRI) have been used previously to determine cortical reorganisation postrehabilitation.16 While fMRI is considered the gold-standard measure in neuroimaging, these techniques may be limited as they only allow for small movements to occur within the scanner that are very different from activities of daily living (ADLs). In this sense, functional near-infrared spectroscopy (fNIRS) may be a more suitable neuroimaging technique as it is able to measure changes in cerebral haemodynamic responses (ie, changes in oxyhaemoglobin and deoxyhaemoglobin (HbO2 and HHb)) in response to larger body and head movements that mimic ADLs. Previous studies have also established that cerebral haemodynamic measures from fNIRS are highly comparable with blood oxygen-level dependent signals from fMRI,17 18 which makes it a suitable surrogate to measure changes in brain activity following VT rehabilitation in people with stroke.
Given the advantages of increased accessibility to specialised treatment and monitoring that is afforded by VT, we aim to determine if an online VT system can provide efficacious UE rehabilitation for community-dwelling stroke survivors. We have chosen to focus our intervention on UE function as impaired arm function is highly common after stroke,2 which profoundly impacts the capacity to perform ADLs19 and only a small number of stroke survivors experience complete functional recovery of the UE.20
Continue —> Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol | BMJ Open
Figure 2 Examples of VT therapy games that target UE mobility of the shoulders, elbows and wrists. UE, upper extremity; VT, Virtual therapy.