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Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial.

ABSTRACT: Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dose-matched conventional training, to assess patient and therapist satisfaction when working with novel virtual reality training and to calculate cost-effectiveness in terms of resources required to regain some degree of dexterity.Randomized controlled observer-blind trial.Virtual reality systems are promising tools for rehabilitation of arm motor function after stroke. Their introduction in combination with traditional physical and occupational therapy may enhance recovery after stroke, and at the same time demand little personnel resources to increase training intensity. The VIRTUES trial will provide further evidence of VR-based treatment strategies to clinicians, patients and health economists.ClinicalTrials.gov NCT02079103.

SUBMITTER: Brunner I

PROVIDER: S-EPMC4180981 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial.

Brunner Iris I Skouen Jan S JS Hofstad Håkon H Strand Liv I LI Becker Frank F Sanders Anne-Marthe AM Pallesen Hanne H Kristensen Tove T Michielsen Marc M Verheyden Geert G

BMC neurology 20140928

<h4>Background</h4>Novel virtual reality rehabilitation systems provide the potential to increase intensity and offer challenging and motivating tasks. The efficacy of virtual reality systems to improve arm motor function early after stroke has not been demonstrated yet in sufficiently powered studies. The objective of the study is to investigate whether VR training as an adjunct to conventional therapy is more effective in improving arm motor function in the subacute phase after stroke than dos ...[more]

PMID: 25261187

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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 and objectivePrediction of voluntary upper extremity (UE) movement recovery is largely unknown in patients with little voluntary UE movement at admission. The present study aimed to investigate (1) the extent and variation of voluntary UE movement recovery, and (2) the best predictive model of the recovery of voluntary UE movement by clinical variables in patients with severe UE paresis.DesignProspective cohort study.Methods140 (out of 590) stroke patients with severe UE paresis completed all assessments. Voluntary UE movement was assessed using the UE subscale of the Stroke Rehabilitation Assessment of Movement (STREAM-UE). Two outcome measures, STREAM-UE scores at discharge (DC(STREAM-UE)) and changes between admission and discharge (Δ(STREAM-UE)), were investigated to represent the final states and improvement of the recovery of voluntary UE movement. Stepwise regression analyses were used to investigate 19 clinical variables and to find the best predictive models of the two outcome measures.ResultsThe participants showed wide variation in both DC(STREAM-UE) and Δ(STREAM-UE). 3.6% of the participants almost fully recovered at discharge (DC(STREAM-UE) > 15). A large improvement (Δ(STREAM-UE) >= 10) occurred in 16.4% of the participants, while 32.9% of the participants did not have any improvement. The four predictors for the DC(STREAM-UE) (R(2) = 35.0%) were 'baseline STREAM-UE score', 'hemorrhagic stroke', 'baseline National Institutes of Health Stroke Scale (NIHSS) score', and 'cortical lesion excluding primary motor cortex'. The three predictors for the Δ(STREAM-UE) (R(2) = 22.0%) were 'hemorrhagic stroke', 'baseline NIHSS score', and 'cortical lesion excluding primary motor cortex'.ConclusionsRecovery of voluntary UE movement varied widely in patients with severe UE paresis after stroke. The predictive power of clinical variables was poor. Both results indicate the complex nature of voluntary UE movement recovery in patients with severe UE paresis after stroke.

Project description:BackgroundStroke is among the leading causes of long-term disability worldwide. Motor impairments after stroke not only impact the individuals quality of life but also lay substantial burdens on the society. Motor planning is a key component of cognitive function that impacts motor control. Hand movements such as grasping or reaching to grasp require the application of correct force and the coordination of multiple limb segments. Successful completion of hand motor task requires a certain degree of cognitive function to anticipate the requirement of the task. Cognitive function may thus be a confounding factor to rehabilitation outcomes.ObjectiveThis study aims to explore the impact of cognitive function on functional outcomes in people with subacute stroke after VR intervention.MethodsPatients with stroke were first stratified into cognitively normal (CN) and cognitively impaired (CI), followed by allocation to the VR or control group (CG). Fugl-Meyer Assessment for Upper Extremity (FMA-UE), Barthel Index (BI), and Instrumental Activities of Daily Living (IADL) were recorded at baseline, 3 weeks after the intervention, and 3 and 6 months after the intervention. The between-group and within-group differences were assessed by repeated-measures analysis of variance (ANOVA).ResultsThe between-group comparison indicated that FMA-UE, BI, and IADL (time effect P<.001 for all) scores improved significantly in both groups after the intervention. Repeated-measures ANOVA indicated that FMA-UE, BI, and IADL (time effect P<.001 for all) were significantly different in each subgroup after the intervention. For BI score, the ANOVA results showed obvious interaction effects (treatment × time × cognitive effect, P=.04).ConclusionsVR intervention was as effective as traditional conventional therapy in improving upper limb function regardless of the cognitive functional level. Patients with stroke with impaired cognitive function may gain more improvement in upper limb function and independency in performing activities of daily living after a VR-based intervention.Trial registrationChinese Clinical Trial Registry ChiCTR-IOC-15006064; https://tinyurl.com/4c9vkrrn.

Project description:Mixed reality (MR), which combines virtual reality and tangible objects, can be used for repetitive training by patients with stroke, allowing them to be immersed in a virtual environment while maintaining their perception of the real world. We developed an MR-based rehabilitation board (MR-board) for the upper limb, particularly for hand rehabilitation, and aimed to demonstrate the feasibility of the MR-board as a self-training rehabilitation tool for the upper extremity in stroke patients. The MR-board contains five gamified programs that train upper-extremity movements by using the affected hand and six differently shaped objects. We conducted five 30-min training sessions in stroke patients using the MR-board. The sensor measured hand movement and reflected the objects to the monitor so that the patients could check the process and results during the intervention. The primary outcomes were changes in the Box and Block Test (BBT) score, and the secondary outcomes were changes in the Fugl–Meyer assessment and Wolf Motor Function Test (WMFT) scores. Evaluations were conducted before and after the intervention. In addition, a usability test was performed to assess the patient satisfaction with the device. Ten patients with hemiplegic stroke were included in the analysis. The BBT scores and shoulder strength in the WMFT were significantly improved (p < 0.05), and other outcomes were also improved after the intervention. In addition, the usability test showed high satisfaction (4.58 out of 5 points), and patients were willing to undergo further treatment sessions. No safety issues were observed. The MR-board is a feasible intervention device for improving upper limb function. Moreover, this instrument could be an effective self-training tool that provides training routines for stroke patients without the assistance of a healthcare practitioner. Trial registration This study was registered with the Clinical Research Information Service (CRIS: KCT0004167).

Dataset Information

Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial.

Publications

Virtual reality training for upper extremity in subacute stroke (VIRTUES): study protocol for a randomized controlled multicenter trial.

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