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

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: CTRI/2021/11/038339.

Keywords: Clinical trials; Physical Therapy Modalities; Quality of Life; REHABILITATION MEDICINE; Randomized Controlled Trial; STROKE MEDICINE.

Figure 1. Schematic representation of the randomised controlled trial design assessing the VR-cRGS for UE impairment in patients who had an ischaemic stroke. BI, Barthel Index; CP, conventional physiotherapy; FMA-UE, Fugl-Meyer Assessment for upper extremity; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale; SF-36, 36-item Short Form Survey; VR-CRGS, virtual reality-based comprehensive rehabilitation gaming system; WMFT, Wolf Motor Function Test.

Figure 2. Clinical trial schedule of enrolment, interventions and assessments. BI, Barthel Index; CP, conventional physiotherapy; FMA-UE, Fugl-Meyer Assessment for upper extremity; mRS, modified Rankin scale; NIHSS, National Institutes of Health Stroke Scale; SF-36, 36-item Short Form Survey; VR-CRGS, virtual reality based-comprehensive rehabilitation gaming system; WMFT, Wolf Motor Function Test.