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
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《BMJ Open》
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》
Effectiveness of Using Virtual Reality-Supported Exercise Therapy for Upper Extremity Motor Rehabilitation in Patients With Stroke: Systematic Review and Meta-analysis of Randomized Controlled Trials.
In recent years, efforts have been made to implement virtual reality (VR) to support the delivery of poststroke upper extremity motor rehabilitation exercises. Therefore, it is important to review and analyze the existing research evidence of its effectiveness.
Through a systematic review and meta-analysis of randomized controlled trials, this study examined the effectiveness of using VR-supported exercise therapy for upper extremity motor rehabilitation in patients with stroke.
This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. The CINAHL Plus, MEDLINE, Web of Science, Embase, and Cochrane Library databases were searched on December 31, 2021. Changes in outcomes related to impairments in upper extremity functions and structures, activity limitations, and participation restrictions in life situations from baseline to after intervention, after intervention to follow-up assessment, and baseline to follow-up assessment were examined. Standardized mean differences (SMDs) were calculated using a random-effects model. Subgroup analyses were performed to determine whether the differences in treatment outcomes depended on age, stroke recovery stage, VR program type, therapy delivery format, similarities in intervention duration between study groups, intervention duration in VR groups, and trial length.
A total of 42 publications representing 43 trials (aggregated sample size=1893) were analyzed. Compared with the control groups that used either conventional therapy or no therapy, the intervention groups that used VR to support exercise therapy showed significant improvements in upper extremity motor function (Fugl-Meyer Assessment-Upper Extremity; SMD 0.45, 95% CI 0.21-0.68; P<.001), range of motion (goniometer; SMD 1.01, 95% CI 0.50-1.52; P<.001), muscle strength (Manual Muscle Testing; SMD 0.79, 95% CI 0.28-1.30; P=.002), and independence in day-to-day activities (Functional Independence Measure; SMD 0.23, 95% CI 0.06-0.40; P=.01, and modified Rankin Scale; SMD 0.57, 95% CI 0.01-1.12; P=.046). Significant subgroup differences were observed in hand dexterity (Box and Block Test), spasticity (Ashworth Scale or modified Ashworth Scale), arm and hand motor ability (Wolf Motor Function Test and Manual Function Test), hand motor ability (Jebsen Hand Function Test), and quality of life (Stroke Impact Scale). There was no evidence that the benefits of VR-supported exercise therapy were maintained after the intervention ended.
VR-supported upper extremity exercise therapy can be effective in improving motor rehabilitation results. Our review showed that of the 12 rehabilitation outcomes examined during the course of VR-based therapy, significant improvements were detected in 2 (upper extremity motor function and range of motion), and both significant and nonsignificant improvements were observed in another 2 (muscle strength and independence in day-to-day activities), depending on the measurement tools or methods used.
PROSPERO CRD42021256826; https://tinyurl.com/2uarftbh.
Chen J
,Or CK
,Chen T
《JOURNAL OF MEDICAL INTERNET RESEARCH》
Virtual reality-based neuroproprioceptive physiotherapy in multiple sclerosis: a protocol for a double-arm randomised assessor-blinded controlled trial on upper extremity function, postural function and quality of life, with molecular and functional MRI a
Upper limb (UL) impairment is common in people with multiple sclerosis (pwMS), and functional recovery of the UL is a key rehabilitation goal. Technology-based approaches, like virtual reality (VR), are increasingly promising. While most VR environments are task-oriented, our clinical approach integrates neuroproprioceptive 'facilitation and inhibition' (NFI) principles. To advance this, we developed immersive VR software based on NFI principles targeting UL function and sit-to-stand ability. This study aims to evaluate the effectiveness of this VR therapy compared with conventional NFI-based physical therapy in pwMS. Our study uniquely applies advanced imaging techniques, along with biological molecular assessments, to explore adaptive processes induced by VR rehabilitation.
This double-arm, randomised, assessor-blinded, controlled trial runs over 2 months (1 hour, 2 times per week). PwMS with mild to severe disability will receive either VR therapy or real-world physical therapy. Primary outcomes include the nine-hole peg test, box and block test, handgrip strength, tremor and five times sit-to-stand test. Secondary measures include the Multiple Sclerosis Impact Scale, the 5-level EQ-5D questionnaire and kinematic analysis. Adaptive processes will be monitored using imaging techniques (functional MRI and tractography), molecular genetic methods (long non-coding RNAs) and immune system markers (leukocytes, dendritic cells). The International Classification of Functioning, Disability and Health brief set for MS will map the bio-psycho-social context of participants.
This project and its amendments were approved by the Ethics Committee of the Institute for Clinical and Experimental Medicine and Thomayer Hospital (1983/21+4772/21 (G-21-02) and the Ethics Committee of Kralovske Vinohrady University Hospital (EK-VP/38/0/2021) in Prague, Czechia (with single enrolment). The findings of this project will be disseminated through scientific publications, conferences, professional networks, public engagement, educational materials and stakeholder briefings to ensure a broad impact across clinical, academic and public domains.
clinicaltrials.gov (NCT04807738).
Miznerova B
,Reissigova J
,Vasa L
,Frank J
,Hudec M
,Rodina L
,Herynkova A
,Havlik J
,Tintera J
,Rydlo J
,Ibrahim I
,O'Leary VB
,Cerna M
,Jurickova I
,Pokorna M
,Philipp T
,Hlinovska J
,Stetkarova I
,Rasova K
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