Innovative STRoke Interactive Virtual thErapy (STRIVE) online platform for community-dwelling stroke survivors: a randomised controlled trial protocol.

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. 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. 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. ACTRN12617000745347; Pre-results.

Johnson L ，Bird ML ，Muthalib M ，Teo WP ... -  《BMJ Open》

An Innovative STRoke Interactive Virtual thErapy (STRIVE) Online Platform for Community-Dwelling Stroke Survivors: A Randomized Controlled Trial.

To investigate the STRoke Interactive Virtual thErapy (STRIVE) intervention on upper-extremity clinical outcomes in community-dwelling stroke survivors. Assessor-blinded randomized controlled trial. Study screening and testing was conducted in a university clinic. Participants completed the virtual therapy (VT) intervention in a community-based stroke support group setting. Of 124 stroke survivors initially assessed, 60 participants were recruited (time poststroke, 13.4±8.9 y). Participants were allocated to either VT or control group using a block randomization design and were stratified by sex. Participants were randomized to receive 8 weeks of VT or usual care. The intervention consisted of approximately 45 minutes of twice weekly VT training on the Jintronix Rehabilitation System. Between-group differences in the Fugl-Meyer Upper Extremity scale and Action Research Arm Test score were joint primary outcomes in this study. Significant between-group differences for the Fugl-Meyer Upper Extremity scale were seen at the end of the intervention (F1, 1=5.37, P=.02, d=0.41). No significant differences were observed with the Action Research Arm Test. No adverse events were reported. We demonstrated clinically meaningful improvements in gross upper extremity motor function and use of the affected arm after a VT intervention delivered via a community-based stroke support group setting. This data adds to the contexts in which VT can be used to improve upper limb function. Use of VT in community-based rehabilitation in chronic stroke recovery is supported.

Johnson L ，Bird ML ，Muthalib M ，Teo WP ... -  《-》

Feasibility and efficacy of virtual reality rehabilitation compared with conventional physiotherapy for upper extremity impairment due to ischaemic stroke: protocol for a randomised controlled trial.

Approximately half of all stroke survivors have persistent upper extremity functional impairment, leading to reduced self-care, independence and quality of life. High-intensity, task-oriented virtual reality rehabilitation improves motor recovery. However, its clinical efficacy over standard rehabilitation remains uncertain. This study aims to evaluate the feasibility and efficacy of a virtual reality-based comprehensive rehabilitation gaming system (VR-cRGS) in stroke survivors with upper extremity impairment and to characterise the structural and functional plasticity of the affected regions in the brain due to the proposed rehabilitation. This study is a multicentric, open-label, randomised controlled trial with an intention-to-treat analysis. A total of 162 patients will be enrolled in two academic institutes in India that specialise in stroke care. Patients with a first-ever ischaemic stroke (18-70 years and 1-6 months of stroke onset) with upper extremity impairment with 1 and 1+ grades of spasticity as per the modified Ashworth Scale and 3, 4 or 5 stages on Brunnstrom recovery staging will be enrolled. They will be randomised (1:1) into two treatment groups to receive 12 weeks of training either on VR-cRGS or on conventional physiotherapy. The primary feasibility outcome is compliance with the treatment. The primary efficacy outcome is the functional recovery of the upper extremity assessed by the Fugl-Meyer Assessment-Upper Extremity and Wolf Motor Function Test. The secondary outcomes are the Barthel Index and the 36-item Short-Form Health Survey. Multimodal brain imaging will be done in all enrolled patients at baseline and post-treatment to evaluate the structural and functional connectivity changes. The outcome measures will be analysed using paired t-tests or non-parametric tests. The study has been approved by the Institutional Ethics Review Board of the Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, India (SCT/IEC/1415/AUGUST-2019) and the National Institute of Mental Health and Neurosciences, Bengaluru, Karnataka, India (NIMHANS/IEC (BS and NS DIV.)/32nd Meeting/21). All participants will sign an informed consent form prior to participation. The study results will be disseminated through scholarly publication. CTRI/2021/11/038339.

Paul R ，Elango S ，Chakravarthy S ，Sinha A ，P R S ，Raju B ，C K ，Sarma PS ，Hafsath S ，Francis AJA ，Darshini D ，Sylaja PN ... -  《BMJ Open》

Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke (RHOMBUS): protocol of an intervention feasibility trial.

Effective interventions to promote upper-limb recovery poststroke are characterised by intensive and repetitive movements. However, the repetitive nature of practice may adversely impact on adherence. Therefore, the development of rehabilitation devices that can be used safely and easily at home, and are motivating, enjoyable and affordable is essential to the health and well-being of stroke survivors.The Neurofenix platform is a non-immersive virtual reality device for poststroke upper-limb rehabilitation. The platform uses a hand controller (a NeuroBall) or arm bands (NeuroBands) that facilitate upper-limb exercise via games displayed on a tablet. The Rehabilitation via HOMe Based gaming exercise for the Upper-limb post Stroke trial aims to determine the safety, feasibility and acceptability of the Neurofenix platform for home-based rehabilitation of the upper-limb poststroke. Thirty people poststroke will be provided with a Neurofenix platform, consisting of a NeuroBall or NeuroBands (dependent on impairment level), seven specially designed games, a tablet and handbook to independently exercise their upper limb for 7 weeks. Training commences with a home visit from a research therapist to teach the participant how to safely use the device. Outcomes assessed at baseline and 8 weeks and 12 weeks are gross level of disability, pain, objectively measured arm function and impairment, self-reported arm function, passive range of movement, spasticity, fatigue, participation, quality of life (QOL) and health service use. A parallel process evaluation will assess feasibility, acceptability and safety of the intervention through assessment of fidelity to the intervention measured objectively through the Neurofenix platform, a postintervention questionnaire and semistructured interviews exploring participants' experiences of the intervention. The feasibility of conducting an economic evaluation will be determined by collecting data on QOL and resource use. Ethics approval granted from Brunel University London (10249-MHR-Mar/2018-12322-2). Trial results will be submitted for publication in journals, presented at national and international conferences and distributed to people with stroke. ISRCTN60291412; Pre-results.

Kilbride C ，Scott DJM ，Butcher T ，Norris M ，Ryan JM ，Anokye N ，Warland A ，Baker K ，Athanasiou DA ，Singla-Buxarrais G ，Nowicky A ... -  《BMJ Open》

Effectiveness of a multifactorial context-enhancing functional therapy to promote functional arm use and recovery of stroke survivors: study protocol for a clinical trial.

After a stroke, 55% of survivors do not regain the ability to completely use their arm in daily life functioning. Currently, evidence-based guidelines recommend functional training for improving the affected hand after stroke. However, promoting an optimal quantity and quality of functional training is influenced by personal and environmental contextual factors. Studies that comprehensively target multiple factors regulating arm use are limited. This study compares the effects of functional training to multifactorial context-enhancing functional training program for improving functional arm use and recovery after stroke. This is a protocol for an observer-blinded, two parallel groups, randomised controlled trial. A total of 126 community-dwelling subacute and chronic stroke survivors will be included in the study. A tailor-made multifactorial context-enhancing intervention-incorporating education, environmental enrichment and behaviour change techniques to reinforce functional training will be provided to the experimental group. The functional training group will be provided with functional exercises. The intervention will be delivered for 2 months. The primary outcomes of functional arm use and recovery will be measured using Motor Activity Log, Goal Attainment Scale and Rating of Everyday Arm-use in the Community and Home scale. The secondary outcomes of arm motor impairment and function will be measured using Fugl-Meyer upper limb score, Action Research Arm Test, ABILHAND questionnaire and Stroke Impact Scale. These will be measured at three points in time: before, after 2 months and after 1-month follow-up. The outcome measures will be analysed using one-way analysis of variance and regression analysis will be performed to identify factors limiting optimal task practice. The study has been approved by the Institutional Ethics Committee of Kasturba Hospital, Manipal, India. Participants will sign a written informed consent prior to participation. The results will be published on completion of the trial and communicated to community-dwelling stroke survivors. CTRI/2017/10/010108.

Rajagopalan V ，Natarajan M ，Gorthi SP ，Padickaparambil S ，Solomon JM ... -  《BMJ Open》