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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:ObjectiveFew effective treatments improve upper extremity (UE) function after stroke. Immersive virtual reality (imVR) is a novel and promising strategy for stroke UE recovery. We assessed the extent to which imVR-based UE rehabilitation can augment conventional treatment and explored changes in brain functional connectivity (FC) that were related to the rehabilitation.MethodsAn assessor-blinded, parallel-group randomized controlled trial was performed with 40 subjects randomly assigned to either imVR or Control group (1:1 allocation), each receiving rehabilitation 5 times per week for 3 weeks. Subjects in the imVR received both imVR and conventional rehabilitation, while those in the Control received conventional rehabilitation only. Our primary and secondary outcomes were the Fugl-Meyer assessment's upper extremity subscale (FMA-UE) and the Barthel Index (BI), respectively. Both intention-to-treat (ITT) and per-protocol (PP) analyses were performed to assess the effectiveness of the trial. For both the FMA-UE/BI, a one-way analysis of covariance (ANCOVA) model was used, with the FMA-UE/BI at post-intervention or at follow-up, respectively, as the dependent variable, the two groups as the independent variable, baseline FMA-UE/BI, age, sex, site, time since onset, hypertension and diabetes as covariates.ResultsBoth ITT and PP analyses demonstrated the effectiveness of imVR-based rehabilitation. The FMA-UE score was greater in the imVR compared with the Control at the post-intervention (mean difference: 9.1 (95% CI 1.6, 16.6); P = 0.019) and follow-up (mean difference:11.5 (95% CI 1.9, 21.0); P = 0.020). The results were consistent for BI scores. Moreover, brain FC analysis found that the motor function improvements were associated with a change in degree in ipsilesional premotor cortex and ipsilesional dorsolateral prefrontal cortex immediately following the intervention and in ipsilesional visual region and ipsilesional middle frontal gyrus after the 12-week follow-up.ConclusionsImVR-based rehabilitation is an effective tool that can improve the recovery of UE functional capabilities of subacute stroke patients when added to standard care. These improvements were associated with distinctive brain changes at two post-stroke timepoints. The study results will benefit future patients with stroke and provide evidence for a promising new method of stroke rehabilitation.Trial registrationClinicalTrials.gov identifier: NCT03086889.

Project description:IntroductionMedications for opioid use disorder (MOUD) are the most effective interventions for this condition, yet many patients discontinue treatment. Though adjunct psychosocial treatments are recommended to increase retention and reduce relapse, the scarcity of trained providers hinders access to and utilization of evidence-based interventions. We conducted a Phase 1 study to assess the feasibility of a virtual reality-delivered Mindfulness-Oriented Recovery Enhancement (MORE-VR) intervention for patients receiving MOUD.Patients and methodsPatients receiving buprenorphine or methadone for OUD (N = 34) were scheduled for 8 weekly sessions of MORE-VR. Enrollment and retention rates were analyzed. Participants reported on the usability and acceptability of MORE-VR, opioid use, and craving and affect before and after each VR session. Heart rate was monitored during one session of MORE-VR.ResultsTwenty-three participants completed four or more MORE-VR sessions (minimum recommended intervention dose). Participants reported high usability and acceptability of MORE-VR, which had an excellent safety profile. Illicit opioid use decreased significantly from pre- to post-treatment (F = 4.44, p=.04). We observed a significant within-session decrease in opioid craving (F = 39.3, p<.001) and negative affect (F = 36.3, p<.001), and a significant within-session increase in positive affect (F = 23.6, p<.001). Heart rate shifted during cue-exposure and mindfulness practices (F = 6.79, p<.001).ConclusionsHigh retention, usability and acceptability rates and low adverse events demonstrated that MORE-VR is a feasible, engaging, and safe intervention. Our findings show that MORE-VR can be delivered as an adjunctive intervention to MOUD and suggest that MORE-VR may improve OUD treatment outcomes and modulate autonomic responses. MORE-VR's efficacy will be tested in a subsequent Phase 2 trial.Trial registrationClinicalTrials.gov NCT05034276; https://classic.clinicaltrials.gov/ct2/show/NCT05034276.

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:BackgroundPulmonary rehabilitation is a vital component of comprehensive care for patients with respiratory conditions, such as lung cancer, chronic obstructive pulmonary disease, and asthma, and those recovering from respiratory diseases like COVID-19. It aims to enhance patients' functional ability and quality of life, and reduce symptoms, such as stress, anxiety, and chronic pain. Virtual reality is a novel technology that offers new opportunities for customized implementation and self-control of pulmonary rehabilitation through patient engagement.ObjectiveThis review focused on all types of virtual reality technologies (nonimmersive, semi-immersive, and fully immersive) that witnessed significant development and were released in the field of pulmonary rehabilitation, including breathing exercises, biofeedback systems, virtual environments for exercise, and educational models.MethodsThe review screened 7 electronic libraries from 2010 to 2023. The libraries were ACM Digital Library, Google Scholar, IEEE Xplore, MEDLINE, PubMed, Sage, and ScienceDirect. Thematic analysis was used as an additional methodology to classify our findings based on themes. The themes were virtual reality training, interaction, types of virtual environments, effectiveness, feasibility, design strategies, limitations, and future directions.ResultsA total of 2319 articles were identified, and after a detailed screening process, 32 studies were reviewed. Based on the findings of all the studies that were reviewed (29 with a positive label and 3 with a neutral label), virtual reality can be an effective solution for pulmonary rehabilitation in patients with lung cancer, chronic obstructive pulmonary disease, and asthma, and in individuals and children who are dealing with mental health-related disorders, such as anxiety. The outcomes indicated that virtual reality is a reliable and feasible solution for pulmonary rehabilitation. Interventions can provide immersive experiences to patients and offer tailored and engaging rehabilitation that promotes improved functional outcomes of pulmonary rehabilitation, breathing body awareness, and relaxation breathing techniques.ConclusionsThe identified studies on virtual reality in pulmonary rehabilitation showed that virtual reality holds great promise for improving the outcomes and experiences of patients. The immersive and interactive nature of virtual reality interventions offers a new dimension to traditional rehabilitation approaches, providing personalized exercises and addressing psychological well-being. However, additional research is needed to establish standardized protocols, identify the most effective strategies, and evaluate long-term benefits. As virtual reality technology continues to advance, it has the potential to revolutionize pulmonary rehabilitation and significantly improve the lives of patients with chronic lung diseases.

Project description:BackgroundParkinson'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.ObjectivesThe 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 methodsWe 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 criteriaWe 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 analysisTwo 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 resultsWe 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' conclusionsWe 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:BackgroundThere 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.MethodsSubjects (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.DiscussionEffectiveness 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 registrationClinicalTrials.gov, NCT03086889 . Registered on March 22, 2017.

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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