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The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

ABSTRACT: Background and rationale:Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus standard therapy on the recovery of the upper limb motor function in patients with stroke in the early subacute recovery phase. Method:This is a randomized, controlled trial that will assign 262 patients to tailor-made standard rehabilitation (TMSR) or TMSR plus immersive VR device. The trial will be conducted in an urban rehabilitation clinic in the United States with expertise in the management of poststroke patients. Patients will be 18 to 70?years of age and in the early subacute period (30-90?days post ischemic stroke). The primary outcome will be the change of Fugl-Meyer Assessment-Upper Extremity (FMA-UE) score, measured at baseline and 13?weeks after randomization. The secondary outcome will be the change in the UK Functional Independence Measure and Functional Assessment Measure (UK FIM-FAM) score at the same time points. Discussion:If the use of VR in the rehabilitation of patients with stroke proves to have a significant impact on their motor recovery, it will constitute an extremely important step into decreasing the functional impairment associated with stroke and the related health care expense burden.

SUBMITTER: Ahmed N

PROVIDER: S-EPMC6974741 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

Ahmed Nima N Mauad Vitor A Queiroz VAQ Gomez-Rojas Olga O Sushea Ammu A Castro-Tejada Gelanys G Michel Janet J Liñares Juan Manuel JM Pedrosa Salles Loise L Candido Santos Ludmilla L Shan Ming M Nassir Rami R Montañez-Valverde Raul R Fabiano Ronaldo R Danyi Sofia S Hassan Hosseyni Seyed S Anand Seerat S Ahmad Usman U Casteleins William Augusto WA Sanchez Alma Tamara AT Fouad Ahmed A Jacome Alvaro A Moura de Oliveira Paiva Mariana Sanali MS Saavedra Ruiz Ana Gabriela AG Grochowski Rubens A RA Toyama Mayumi M Nagi Hibatalla H Sarvodelli Marcella Zanini MZ Halalau Alexandra A

Journal of central nervous system disease 20200121

<h4>Background and rationale</h4>Stroke is considered the most common cause of adult disability. Intensive rehabilitation protocols outperform nonintensive counterparts. The subacute stroke phase represents a potential window to recovery. Virtual reality (VR) has been shown to provide a more stimulating environment, allowing for increased patient compliance. However, the quality of current literature comparing VR with standard therapies is limited. Our aim is to measure the impact of VR versus s ...[more]

PMID: 32009828

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Project description:Stroke is a major cause of death and disability in adults. Conventional therapy (CT) has limited effectiveness, and therefore, various virtual reality (VR) rehabilitation programs have been designed. However, their efficacy in regaining motor function in patients with subacute stroke is questionable. Therefore, we conducted this meta-analysis to determine the efficacy of VR, compared to CT, in restoring motor function in this patient population. Up to October 10, 2020, nine electronic databases were searched for relevant articles reporting the effectiveness of VR in regaining motor function in patients with subacute stroke. This search was updated on March 7, 2021, with no additional added articles. The control group included CT, physical therapy, occupational therapy, or a combination of them. Effectiveness is defined as the positive change from baseline values to the last follow-up point. The Cochrane's revised risk-of-bias tool was used to determine the quality of included trials. A metaregression analysis was conducted to determine the effect of "time since last stroke" on reported outcomes. Publication bias and sensitivity analyses were also carried out. A total of 19 studies (17 randomized controlled trials, 1 cohort study, and 1 crossover trial) were included in the qualitative analysis, whereas 16 trials were meta-analyzed. A great improvement in motor function was noted in the VR group, when compared to preintervention values [standardized mean difference (SMD) = 1.14; 95% confidence interval (CI) = 0.77-1.52; I 2 = 82%; P < 0.001]. When compared to CT, VR resulted in mild improvement in motor function (SMD = 0.47; 95% CI = 0.22-0.72; I 2 = 75%; P < 0.001). However, upon trim-and-fill adjustment, this finding was deemed insignificant (SMD = 0.08; 95% CI = -0.16 to 0.33; I 2 = 82.6%; P < 0.001). Ten studies had low risk, five had some concerns, three had high risk, and one had a moderate risk of bias. VR programs can be used jointly with CT for the rehabilitation of the motor function of patients with subacute stroke. However, more studies are still warranted to determine the effectiveness of these interventions in retaining the cognitive function and physical performance of such patients.

Project description:Objective"Visual Restitution Therapies" (VRT) claim to ameliorate visual field defects of neurological patients by repeated visual light stimulation, leading to training-related neuroplasticity and resulting in reconnection of lesioned neurons in early cortical areas. Because existing systems are stationary, uncomfortable, and unreliable, we developed a training instrument based on virtual reality goggles. The goal of the "Salzburg Visual Field Trainer" (SVFT) is twofold: (1) The device facilitates the clinical evaluation of established neuropsychological rehabilitation approaches, such as VRT. (2) The device enables patients to independently perform VRT based (or other) neuropsychological training methodologies flexibly and comfortably.Methods and analysisThe SVFT was developed on the principles of VRT. Individual configuration of the SVFT is based on perimetric data of the respective patient's visual field. To validate the utmost important aspect of neuropsychological rehabilitation methodologies-that is displaying stimuli precisely in desired locations in the user's visual field-two steps were conducted in this proof-of-concept study: First, we assessed the individual "blind spots" location and extent of 40 healthy, normal sighted participants. This was done with the help of our recently developed perimetric methodology "Eye Tracking Based Visual Field Analysis" (EFA). Second, depending on the individual characteristics of every participant's blind spots, we displayed-by means of the SVFT-15 stimuli in the respective locations of every participants' blind spots and 85 stimuli in the surrounding, intact visual area. The ratio between visible and non-visible stimuli, which is reflected in the behavioral responses (clicks on a remote control) of the 40 participants, provides insight into the accuracy of the SVFT to display training stimuli in areas desired by the investigator. As the blind spot is a naturally occurring, absolute scotoma, we utilized this blind area as an objective criterion and a "simulated" visual field defect to evaluate the theoretical applicability of the SVFT.ResultsOutcomes indicate that the SVFT is highly accurate in displaying training stimuli in the desired areas of the user's visual field with an accuracy of 99.0%. Data analysis further showed a sensitivity of .98, specificity of .99, a positive predictive value of .96, a negative predictive value of .996, a hit rate of .99, a random hit rate of .74 and a RATZ-Index of .98. This translates to 14.7% correct non-reactions, 0.7% false non-reactions, 0.3% false reactions and 84.3% correct reactions to displayed test stimuli during the evaluation study. Reports from participants further indicate that the SVFT is comfortable to wear and intuitive to use.ConclusionsThe SVFT can help to investigate the true effects of VRT based methodologies (or other neuropsychological approaches) and the underlying mechanisms of training-related neuroplasticity in the visual cortex in neurological patients suffering from visual field defects.

Project description:Introduction: Innovative motor therapies have attempted to reduce upper extremity impairment after stroke but have not made substantial improvement as over 50% of people post-stroke continue to have sensorimotor deficits affecting their self-care and participation in daily activities. Intervention studies have focused on the role of increased dosing, however recent studies have indicated that timing of rehabilitation interventions may be as important as dosing and importantly, that dosing and timing interact in mediating effectiveness. This study is designed to empirically test dosing and timing. Methods and Analysis: In this single-blinded, interventional study, subjects will be stratified on two dimensions, impairment level (Fugl-Meyer Upper Extremity Assessment (FM) and presence or absence of Motor Evoked Potentials (MEPs) as follows; (1) Severe, FM score 10-19, MEP+, (2) Severe, FM score 10-19, MEP-, (3) Moderate, FM score 20-49, MEP+, (4) Moderate, FM score 20-49, MEP-. Subjects not eligible for TMS will be assigned to either group 2 (if severe) or group 3 (if moderate). Stratified block randomization will then be used to achieve a balanced assignment. Early Robotic/VR Therapy (EVR) experimental group will receive in-patient usual care therapy plus an extra 10 h of intensive upper extremity therapy focusing on the hand using robotically facilitated rehabilitation interventions presented in virtual environments and initiated 5-30 days post-stroke. Delayed Robotic/VR Therapy (DVR) experimental group will receive the same intervention but initiated 30-60 days post-stroke. Dose-matched usual care group (DMUC) will receive an extra 10 h of usual care initiated 5-30 days post-stroke. Usual Care Group (UC) will receive the usual amount of physical/occupational therapy. Outcomes: There are clinical, neurophysiological, and kinematic/kinetic measures, plus measures of daily arm use and quality of life. Primary outcome is the Action Research Arm Test (ARAT) measured at 4 months post-stroke. Discussion: Outcome measures will be assessed to determine whether there is an early time period in which rehabilitation will be most effective, and whether there is a difference in the recapture of premorbid patterns of movement vs. the development of an efficient, but compensatory movement strategy. Ethical Considerations: The IRBs of New Jersey Institute of Technology, Rutgers University, Northeastern University, and Kessler Foundation reviewed and approved all study protocols. Study was registered in https://ClinicalTrials.gov (NCT03569059) prior to recruitment. Dissemination will include submission to peer-reviewed journals and professional presentations.

Project description:BACKGROUND:Parkinson's disease (PD) is a neurodegenerative disorder that is best managed by a combination of medication and regular physiotherapy. In this context, virtual reality (VR) technology is proposed as a new rehabilitation tool with a possible added value over traditional physiotherapy approaches. It potentially optimises motor learning in a safe environment, and by replicating real-life scenarios could help improve functional activities of daily living. OBJECTIVES:The objective of this review was to summarise the current best evidence for the effectiveness of VR interventions for the rehabilitation of people with PD in comparison with 1) active interventions, and 2) passive interventions. Our primary goal was to determine the effect of VR training on gait and balance. Secondary goals included examining the effects of VR on global motor function, activities of daily living, quality of life, cognitive function, exercise adherence, and the occurrence of adverse events. SEARCH METHODS:We identified relevant articles through electronic searches of the Cochrane Movement Disorders Group Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library), MEDLINE, Embase, CINAHL, the Physiotherapy Evidence Database (PEDro), online trials registers, and by handsearching reference lists. We carried out all searches up until 26 November 2016. SELECTION CRITERIA:We searched for randomised and quasi-randomised controlled trials of VR exercise interventions in people with PD. We included only trials where motor rehabilitation was the primary goal. DATA COLLECTION AND ANALYSIS:Two review authors independently searched for trials that corresponded to the predefined inclusion criteria. We independently extracted and assessed all data for methodological quality. A third review author was responsible for conflict resolution when required. MAIN RESULTS:We included 8 trials involving 263 people with PD in the review. Risk of bias was unclear or high for all but one of the included studies. Study sample sizes were small, and there was a large amount of heterogeneity between trials with regard to study design and the outcome measures used. As a result, we graded the quality of the evidence as low or very low. Most of the studies intended to improve motor function using commercially available devices, which were compared with physiotherapy. The interventions lasted for between 4 and 12 weeks.In comparison to physiotherapy, VR may lead to a moderate improvement in step and stride length (standardised mean difference (SMD) 0.69, 95% confidence interval (CI) 0.30 to 1.08; 3 studies; 106 participants; low-quality evidence). VR and physiotherapy interventions may have similar effects on gait (SMD 0.20, 95% CI -0.14 to 0.55; 4 studies; 129 participants; low-quality evidence), balance (SMD 0.34, 95% CI -0.04 to 0.71; 5 studies; 155 participants; low-quality evidence), and quality of life (mean difference 3.73 units, 95% CI -2.16 to 9.61; 4 studies; 106 participants). VR interventions did not lead to any reported adverse events, and exercise adherence did not differ between VR and other intervention arms.The evidence available comparing VR exercise with a passive control was more limited. The evidence for the main outcomes of interest was of very low quality due to the very small sample sizes of the two studies available for this comparison. AUTHORS' CONCLUSIONS:We found low-quality evidence of a positive effect of short-term VR exercise on step and stride length. VR and physiotherapy may have similar effects on gait, balance, and quality of life. The evidence available comparing VR with passive control interventions was more limited. Additional high-quality, large-scale studies are needed to confirm these findings.

Project description:BACKGROUND:There is compelling evidence of beneficial effects of non-immersive virtual reality (VR)-based intervention in the rehabilitation of patients with stroke, whereby patients experience both the real world and the virtual environment. However, to date, research on immersive VR-based rehabilitation is minimal. This study aims to design a randomized controlled trial to assess the effectiveness of immersive VR-based upper extremity rehabilitation in patients with subacute stroke and explore the underlying brain mechanisms of immersive VR-based rehabilitation. METHODS:Subjects (n = 60) with subacute stroke (defined as more than 1?week and less than 12?weeks after stroke onset) will be recruited to participate in a single-blinded, randomized controlled trial. Subjects will be randomized 1:1 to either (1) an experimental intervention group, or (2) a conventional group (control). Over a 3-week time period immediately following baseline assessments and randomization, subjects in the experimental group will receive both immersive VR and conventional rehabilitation, while those in the control group will receive conventional rehabilitation only. During the rehabilitation period and over the following 12?weeks, upper extremity function, cognitive function, mental status, and daily living activity performance will be evaluated in the form of questionnaires. To trace brain reorganization in which upper extremity functions previously performed by ischemic-related brain areas are assumed by other brain areas, subjects will have brain scans immediately following enrollment but before randomization, immediately following the conclusion of rehabilitation, and 12?weeks after rehabilitation has concluded. DISCUSSION:Effectiveness is assessed by evaluating motor improvement using the arm motor section of the Fugl-Meyer assessment. The study utilizes a cutting-edge brain neuroimaging approach to longitudinally trace the effectiveness of both VR-based and conventional training on stroke rehabilitation, which will hopefully describe the effects of the brain mechanisms of the intervention on recovery from stroke. Findings from the trial will greatly contribute to evidence on the use of immersive-VR-based training for stroke rehabilitation. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03086889 . Registered on March 22, 2017.

Project description:BACKGROUND:Remote virtual rehabilitation aroused growing interest in the last decades, and its role has gained importance following the recent spread of COVID19 pandemic. The advantages of virtual reality (VR), augmented reality (AR), gamification, and telerehabilitation have been demonstrated in several medical fields. In this review, we searched the literature for studies using these technologies for orthopedic rehabilitation and analyzed studies' quality, type and field of rehabilitation, patients' characteristics, and outcomes to describe the state of the art of VR, AR, gamification, and telerehabilitation for orthopedic rehabilitation. METHODS:A comprehensive search on PubMed, Medline, Cochrane, CINAHL, and Embase databases was conducted. This review was performed according to PRISMA guidelines. Studies published between 2015 and 2020 about remote virtual rehabilitations for orthopedic patients were selected. The Methodological Index for Non-Randomized Studies (MINORS) and Cochrane Risk-of-Bias assessment tool were used for quality assessment. RESULTS:24 studies (9 randomized controlled trials (RCTs) and 15 non-randomized studies) and 2472 patients were included. Studies mainly concern telerehabilitation (56%), and to a lesser extent VR (28%), AR (28%), and gamification (16%). Remote virtual technologies were used following knee and hip arthroplasty. The majority of included patients were between 40 and 60 years old and had a university degree. Remote virtual rehabilitation was not inferior to face-to-face therapy, and physical improvements were demonstrated by increased clinical scores. Orthopedic virtual remote rehabilitation decreased costs related to transports, hospitalizations, and readmissions. CONCLUSION:The heterogeneity of included studies prevented a meta-analysis of their results. Age and social context influence adaptability to technology, and this can modify compliance to treatment and outcomes. A good relationship between patient and physiotherapist is essential for treatment compliance and new technologies are useful to maintain clinical interactions remotely. Remote virtual technologies allow the delivery of high-quality care at reduced costs. This is a necessity given the growing demand for orthopedic rehabilitation and increasing costs related to it. Future studies need to develop specific and objective methods to evaluate the clinical quality of new technologies and definitively demonstrate advantages of VR, AR, gamification, and telerehabilitation compared to face-to face orthopedic rehabilitation.

Dataset Information

The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

Publications

The Impact of Rehabilitation-oriented Virtual Reality Device in Patients With Ischemic Stroke in the Early Subacute Recovery Phase: Study Protocol for a Phase III, Single-Blinded, Randomized, Controlled Clinical Trial.

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