Virtual Reality Training for Upper Extremity in Subacute Stroke (VIRTUES): A multicenter RCT.

OBJECTIVE: To compare the effectiveness of upper extremity virtual reality rehabilitation training (VR) to time-matched conventional training (CT) in the subacute phase after stroke. METHODS: In this randomized, controlled, single-blind phase III multicenter trial, 120 participants with upper extremity motor impairment within 12 weeks after stroke were consecutively included at 5 rehabilitation institutions. Participants were randomized to either VR or CT as an adjunct to standard rehabilitation and stratified according to mild to moderate or severe hand paresis, defined as ≥20 degrees wrist and 10 degrees finger extension or less, respectively. The training comprised a minimum of sixteen 60-minute sessions over 4 weeks. The primary outcome measure was the Action Research Arm Test (ARAT); secondary outcome measures were the Box and Blocks Test and Functional Independence Measure. Patients were assessed at baseline, after intervention, and at the 3-month follow-up. RESULTS: Mean time from stroke onset for the VR group was 35 (SD 21) days and for the CT group was 34 (SD 19) days. There were no between-group differences for any of the outcome measures. Improvement of upper extremity motor function assessed with ARAT was similar at the postintervention (p = 0.714) and follow-up (p = 0.777) assessments. Patients in VR improved 12 (SD 11) points from baseline to the postintervention assessment and 17 (SD 13) points from baseline to follow-up, while patients in CT improved 13 (SD 10) and 17 (SD 13) points, respectively. Improvement was also similar for our subgroup analysis with mild to moderate and severe upper extremity paresis. CONCLUSIONS: Additional upper extremity VR training was not superior but equally as effective as additional CT in the subacute phase after stroke. VR may constitute a motivating training alternative as a supplement to standard rehabilitation. CLINICALTRIALSGOV IDENTIFIER: NCT02079103. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that for patients with upper extremity motor impairment after stroke, compared to conventional training, VR training did not lead to significant differences in upper extremity function improvement.

Cognitive Deficits in Chronic Stroke Patients: Neuropsychological Assessment, Depression, and Self-Reports.

BACKGROUND: Following stroke, clinicians are challenged to detect and untangle symptoms of cognitive dysfunction and mood disorders. Additionally, they need to evaluate the informative value of self-reports to identify patients in need of further attendance. AIMS: To examine the association between neuropsychological measures, symptoms of depression, and self-reported cognitive function. METHODS: One-hundred and five chronic stroke patients underwent assessment covering 6 cognitive domains and answered the Hospital Anxiety and Depression Scale and the Memory and Thinking Scale from the Stroke Impact Scale 1 year after stroke. Age and gender difference in cognitive impairment were examined; linear regression was used to predict depression scores. Sensitivity and specificity analyses were used to validate self-reported functioning against performance on cognitive tests. RESULTS: Cognitive impairment was observed in 60% of the patients in at least 1 cognitive domain. Cognitive performance was associated with symptoms of depression as well as with self-reported cognitive function. The final analyses revealed low sensitivity and specificity for the Memory and Thinking subscale from the Stroke Impact Scale. CONCLUSION: Cognitive impairment occurs frequently even in patients in a chronic phase after stroke and predicts symptoms of depression. Using the Stroke Impact Scale, clinicians should be aware of low sensitivity of self-reported cognitive function.

A longitudinal study investigating how stroke severity, disability, and physical function the first week post-stroke are associated with walking speed six months post-stroke.

OBJECTIVES: To investigate to which degree stroke severity, disability, and physical function the first week post-stroke are associated with preferred walking speed (PWS) at 6 months. DESIGN: Longitudinal observational study. METHOD: Participants were recruited from a stroke unit and tested within the first week (baseline) and at 6 months post-stroke. Outcome measures were the National Institutes of Health Stroke Scale (NIHSS), the Barthel Index (BI), modified Rankin Scale (mRS), PWS, Postural Assessment Scale for Stroke (PASS), and the Trunk Impairment Scale modified-Norwegian version. Multiple regression models were used to explore which variables best predict PWS at 6 months, and the Receiver Operating Characteristics (ROC) curves to determine the cutoffs. RESULTS: A total of 132 participants post-stroke were included and subdivided into two groups based on the ability to produce PWS at baseline. For the participants that could produce PWS at baseline (WSB group), PASS, PWS, and age at baseline predicted PWS at 6 months with an explained variance of 0.77. For the participants that could not produce a PWS at baseline (NoWSB group), only PASS predicted PWS at 6 months with an explained variance of 0.49. For the Walking speed at baseline (WSB) group, cutoffs at baseline for walking faster than 0.8 m/s at 6 months were 30.5 points on the PASS, PWS 0.75 m/s, and age 73.5 years. For the NoWSB group, the cutoff for PASS was 20.5 points. CONCLUSION: PASS, PWS, and age the first week predicted PWS at 6 months post-stroke for participants with the best walking ability, and PASS alone predicted PWS at 6 months post-stroke for participants with the poorest walking ability.

Is upper limb virtual reality training more intensive than conventional training for patients in the subacute phase after stroke? An analysis of treatment intensity and content.

BACKGROUND: Virtual reality (VR) training is thought to improve upper limb (UL) motor function after stroke when utilizing intensive training with many repetitions. The purpose of this study was to compare intensity and content of a VR training intervention to a conventional task-oriented intervention (CT). METHODS: A random sample of 50 video recordings was analyzed of patients with a broad range of UL motor impairments (mean age 61y, 22 women). Patients took part in the VIRTUES trial and were randomized to either VR or CT and stratified according to severity of paresis. A standardized scoring form was used to analyze intensity, i.e. active use of the affected UL expressed in % of total time, total active time and total duration of a training session in minutes, content of training and feedback. Two raters collected data independently. Linear regression models as well as descriptive and graphical methods were used. RESULTS: Patients in the VR group spent significantly more time actively practicing with an activity rate of 77.6 (8.9) % than patients in the CT 67.3 (13.9) %, (p = .003). This difference was attributed to the subgroup of patients with initially severe paresis (n = 22). While in VR severely impaired patients spent 80.7 % (4.4 %) of the session time actively; they reached 60.6 (12.1) % in CT. VR and CT also differed in terms of tasks and feedback provided. CONCLUSION: Our results indicate that patients with severely impaired UL motor function spent more time actively in VR training, which may influence recovery. The upcoming results of the VIRTUES trial will show whether this is correlated with an increased effect of VR compared to CT. TRIAL REGISTRATION: ClinicalTrials.gov NCT02079103 , February 27, 2014.

Olfactory dysfunction in chronic stroke patients.

BACKGROUND: The aim of the study was to investigate odor identification performance in patients one year after hospital admittance due to stroke. Predictors for olfactory dysfunction were investigated as well as self-reported olfactory function and pleasantness of olfactory items. METHODS: A 1-year prospective study was performed. Stroke location, classification and comorbidities were registered at hospital admission. One year after admission, olfactory function was assessed using standardized olfactory methods (screening for loss of detection sensitivity and an odor identification test). A group of matched controls was derived from a population-based study to compare odor identification performance between groups. Patients were asked for their personal judgment regarding their olfactory function and pleasantness of odorous items. In addition, global cognitive function and symptoms of depression were assessed. RESULTS: A total of 78 patients were enrolled (46 males, 32 females; mean age 68 years) of which 28.2% exhibited reduced olfactory function (hyposmia) and 15.4% exhibited loss of olfactory function (10.3% functional anosmia, 5.1% complete anosmia). Patients showed significantly lower olfactory performance compared to age- and sex-mated matched controls. Predictors of impaired olfactory function were age and NIHSS score. Self-reports indicated no significant differences between patients with normal olfactory function and those with reduced function. Yet, patients having an olfactory dysfunction rated odorous items as significantly less pleasant compared to patients without dysfunction. CONCLUSIONS: Olfactory dysfunction seems to occur frequently after stoke even one year after initial admission. The deficits seem to relate to hyposmia and functional anosmia, and less to a complete loss of smell sensitivity.

Early supported discharge after stroke in Bergen (ESD Stroke Bergen): three and six months results of a randomised controlled trial comparing two early supported discharge schemes with treatment as usual.

BACKGROUND: Stroke causes lasting disability and the burden of stroke is expected to increase substantially during the next decades. Optimal rehabilitation is therefore mandatory. Early supported discharge (ESD) has previously shown beneficial, but all major studies were carried out more than ten years ago. We wanted to implement and study the results of ESD in our community today with comparisons between ESD and treatment as usual, as well as between two different ESD models. METHODS: Patients with acute stroke were included during a three year period (2008-11) in a randomised controlled study comparing two different ESD models to treatment as usual. The two ESD models differed by the location of treatment: either in a day unit or in the patients' homes. Patients in the ESD groups were followed by a multi-disciplinary ambulatory team in the stroke unit and discharged home as early as possible. The ESD models also comprised treatment by a multi-disciplinary community health team for up to five weeks and follow-up controls after 3 and 6 months. Primary outcome was modified Rankin Scale (mRS) at six months. RESULTS: Three-hundred-and-six patients were included. mRS scores and change scores were non-significantly better in the two ESD groups at 3 and 6 months. Within-group improvement from baseline to 3 months was significant in the ESD 1 (p = 0.042) and ESD 2 (p = 0.001) groups, but not in the controls. More patients in the pooled ESD groups were independent at 3 (p = 0.086) and 6 months (p = 0.122) compared to controls and there also was a significant difference in 3 month change score between them (p = 0.049). There were no differences between the two ESD groups. Length of stay in the stroke unit was 11 days in all groups. CONCLUSIONS: Patients in the ESD groups tended to be more independent than controls at 3 and 6 months, but no clear statistically significant differences were found. The added effect of supported discharge and improved follow-up seems to be rather modest. The improved stroke treatment of today may necessitate larger patient samples to demonstrate additional benefit of ESD. CLINICAL TRIAL REGISTRATION: Unique identifier: NCT00771771.

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

BACKGROUND: 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. METHODS/DESIGN: Randomized controlled observer-blind trial. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02079103.

Balance and walking after three different models of stroke rehabilitation: early supported discharge in a day unit or at home, and traditional treatment (control).

OBJECTIVE: To compare the effects on balance and walking of three models of stroke rehabilitation: early supported discharge with rehabilitation in a day unit or at home, and traditional uncoordinated treatment (control). DESIGN: Group comparison study within a randomised controlled trial. SETTING: Hospital stroke unit and primary healthcare. INCLUSION CRITERIA: a score of 2-26 on National Institutes of Health Stroke Scale, assessed with Postural Assessment Scale for Stroke (PASS), and discharge directly home from the hospital stroke unit. INTERVENTIONS: Two intervention groups were given early supported discharge with treatment in either a day unit or the patient's own home. The controls were offered traditional, uncoordinated treatment. OUTCOME MEASURES: Primary: PASS. Secondary: Trunk Impairment Scale-modified Norwegian version; timed Up-and-Go; 5 m timed walk; self-reports on problems with walking, balance, ADL, physical activity, pain and tiredness. The patients were tested before randomisation and 3 months after inclusion. RESULTS: From a total of 306 randomised patients, 167 were tested with PASS at baseline and discharged directly home. 105 were retested at 3 months: mean age 69 years, 63 men, 27 patients in day unit rehabilitation, 43 in home rehabilitation and 35 in a control group. There were no group differences, either at baseline for demographic and test data or for length of stroke unit stay. At 3 months, there was no group difference in change on PASS (p>0.05). Some secondary measures tended to show better outcome for the intervention groups, that is, trunk control, median (95% CI): day unit, 2 (0.28 to 2.31); home rehabilitation, 4 (1.80 to 3.78); control, 1 (0.56 to 2.53), p=0.044; and for self-report on walking, p=0.021 and ADL, p=0.016. CONCLUSIONS: There was no difference in change between the groups for postural balance, but the secondary outcomes indicated that improvement of trunk control and walking was better in the intervention groups than in the control group. TRIAL REGISTRATION: This study is part of the Early Supported Discharge after Stroke in Bergen, ClinicalTrials.gov (NCT00771771).

Early supported discharge after stroke in Bergen (ESD Stroke Bergen): a randomized controlled trial comparing rehabilitation in a day unit or in the patients' homes with conventional treatment.

RATIONALE: As a result of demographic changes with a presumed rapidly increasing number of older people during the coming decades, a strong increase in the incidence and prevalence of stroke should be expected. Early supported discharge implies that the patients are discharged to their homes as soon as feasible and that rehabilitative treatment is offered after the discharge, with the patients being home-dwelling. This has proved beneficial in previous studies. AIMS: The main objective of this study is to further characterize the important components of early supported discharge and to confirm superiority of early supported discharge over conventional treatment. The secondary aim will be to compare two different early supported discharge schemes. These early supported discharge schemes are composed of intensive rehabilitation treatment given by a multidisciplinary team in a day unit and, alternatively, the same treatment given in the patients' homes. DESIGN: The study is conducted as a randomized controlled trial with three arms: two different forms of early supported discharge and a control arm with conventional treatment. Patients with acute stroke admitted to our hospital's stroke unit and living in the Municipality of Bergen are considered for inclusion. A total of 350 stroke patients are expected. STUDY OUTCOMES: Primary outcome is modified Rankin Scale six-months after inclusion. Secondary outcomes include Barthel Index and National Institute of Health Stroke Scale at several points in time after inclusion, as well as many other schemes, questionnaires and physical tests. The study is registered in ClinicalTrials.gov registration number NCT00771771.

The Trunk Impairment Scale - modified to ordinal scales in the Norwegian version.

PURPOSE: To translate the Trunk Impairment Scale (TIS), a measure of trunk control in patients after stroke, into Norwegian (TIS-NV), and to explore its construct validity, internal consistency, intertester and test-retest reliability. METHOD: TIS was translated according to international guidelines. The validity study was performed on data from 201 patients with acute stroke. Fifty patients with stroke and acquired brain injury were recruited to examine intertester and test-retest reliability. Construct validity was analyzed with exploratory and confirmatory factor analysis and item response theory, internal consistency with Cronbach's alpha test, and intertester and test-retest reliability with kappa and intraclass correlation coefficient tests. RESULTS: The back-translated version of TIS-NV was validated by the original developer. The subscale Static sitting balance was removed. By combining items from the subscales Dynamic sitting balance and Coordination, six ordinal superitems (testlets) were constructed. The TIS-NV was renamed the modified TIS-NV (TIS-modNV). After modifications the TIS-modNV fitted well to a locally dependent unidimensional item response theory model. It demonstrated good construct validity, excellent internal consistency, and high intertester and test-retest reliability for the total score. CONCLUSIONS: This study supports that the TIS-modNV is a valid and reliable scale for use in clinical practice and research.