Role of monitoring in management of acute ischemic stroke patients. Treatment in a combined acute and rehabilitation stroke unit: which aspects are most important? Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. Early assessment by a mobile stroke team: a randomised controlled trial. Modified constraint-induced therapy in chronic stroke: results of a single-blinded randomized controlled trial. Mental practice in chronic stroke: results of a randomized, placebo-controlled trial. Use of visual feedback in retraining balance following acute stroke. A randomized, controlled trial of computerized physiologic trend monitoring in an intensive care unit. A six-week, resource-efficient mobility program after discharge from rehabilitation improves standing in people affected by stroke: placebo-controlled, randomised trial.
Although several studies have demonstrated the effectiveness of specialist Stroke Unit (SU) care of stroke patients, there is still disagreement over how these units are best organized. We sought to clarify the role of continuous monitoring of physiological parameters in acute ischemic stroke.
                We conducted a prospective study of 268 first-ever ischemic stroke patients admitted to our Cerebrovascular Department and allocated, according to the availability of beds, to the SU or Cerebrovascular Unit (CU). Statistical analysis compared mortality and outcome at discharge, medical and neurological complications, and length of hospitalization in the 2 care settings.
                Two hundred sixty-eight patients were enrolled. A good outcome at discharge, observed in 114 SU patients (85%) and 78 CU patients (58%) (odds ratio, 2.63; 95% CI, 1.4 to 4.8; P<0.02), was found, on multivariate analysis, to be significantly related to type of care (SU versus CU). A significantly greater proportion of SU patients showed adverse changes in monitored parameters, which required acute medical treatment (SU: 64%; CU: 19%; P<0.0001). The mean duration of these complications was significantly shorter in the SU patients (SU: 1.0 day; CU: 2.4 days; P<0.02), and the outcome in patients experiencing complications covered by the monitoring protocol was significantly better in the SU (66%) than in the CU (35%) group (P<0.0001).
                Admission of acute stroke patients to a monitoring SU may positively influence their outcome at discharge. Confirmation of our findings in larger trials will indicate the need for a revision of the minimum requirements of SUs, with the addition of monitoring as a new requirement. We have previously shown that treatment of acute stroke patients in our stroke unit (SU) compared with treatment in general ward (GWs) improves short- and long-term survival and functional outcome and increases the possibility of earlier discharge to home. The aim of the present study was to identify the differences in treatment between the SU and the GW and to assess which aspects of the SU care which were most responsible for the better outcome.
                Of the 220 patients included in our trial, only 206 were actually treated (SU, 102 patients; GW, 104 patients). For these patients, we identified the differences in the treatment and the consequences of the treatment. We analyzed the factors that we were able to measure and their association with the outcome, discharge to home within 6 weeks.
                Characteristic features in our SU were teamwork, staff education, functional training, and integrated physiotherapy and nursing. Other treatment factors significantly different in the SU from the GW were shorter time to start of the systematic mobilization/training and increased use of oxygen, heparin, intravenous saline solutions, and antipyretics. Consequences of the treatment seem to be less variation in diastolic and systolic blood pressure (BP), avoiding the lowest diastolic BP, and lowering the levels of glucose and temperature in the SU group compared with the GW group. Univariate analyses showed that all these factors except the level of glucose were significantly associated with discharge to home within 6 weeks. In the final multivariate Cox regression model, shorter time to start of the mobilization/training and stabilized diastolic BP were independent factors significantly associated with discharge to home within 6 weeks.
                Shorter time to start of mobilization/training was the most important factor associated with discharge to home, followed by stabilized diastolic BP, indicating that these factors probably were important in the SU treatment. The effects of characteristic features of an SU, such as a specially trained staff, teamwork, and involvement of relatives, were not possible to measure. Such factors might be more important than those actually measured. Stroke patients are more likely to make a good recovery if they receive care in a well-organised stroke unit. However, there are uncertainties about how best to provide such care. We studied 2 key aspects of early stroke unit care: early active mobilisation (EM) and automated monitoring (AM) for physiological complications such as hypoxia.
                This was an observer-blinded, factorial (2 x 2) pilot randomised controlled trial recruiting stroke patients within 36 h of symptom onset. The patients were randomised to 1 of 4 nurse-led treatment protocols: (a) standard stroke unit care, (b) EM, (c) AM or (d) combined EM and AM. The primary outcome was the Rankin score at 3 months. We also report the data on feasibility and safety.
                We randomised 32 patients (mean age = 65 years; mean baseline modified NIH score = 6). On unadjusted comparisons, the EM patients were significantly (p < 0.05) more likely to mobilise very early (within 1 h of randomisation) and to achieve walking by day 5 and were less likely to develop complications of immobility. The AM group was significantly (p < 0.05) more likely to have pre-defined physiological complication events detected. All these associations remained, but were less statistically significant, after correcting for age, baseline NIH score and co-interventions. There were no significant safety concerns.
                We have demonstrated the feasibility of implementing EM and AM for physiological complications in a randomised controlled trial. Larger trials are warranted to determine whether these interventions have clinical benefits.
                (c) 2010 S. Karger AG, Basel. There is overwhelming evidence of the effectiveness of specialist stroke rehabilitation, but more limited evidence of the effectiveness of organised stroke care during the acute phase of stroke.
                To determine the impact on outcome of access to a mobile team during the acute phase of stroke among patients admitted to general wards.
                308 patients admitted to one of two hospitals within 5 days of the onset of a clinically diagnosed stroke.
                Randomised controlled trial. STUDY GROUPS: Following admission, patients in the intervention arm were visited by members of a mobile stroke team who advised clinical staff on appropriate and timely investigation and management. They co-ordinated early input from therapy groups and identified those ready for transfer to the stroke rehabilitation unit. Patients in the control arm were not visited by the mobile stroke team.
                All-cause mortality measured at 6 weeks and 12 months.
                There was no statistically significant difference observed between study groups in mortality at 6 weeks (95% CI(adj) -7.4 to 7.4%) nor at 12 months ( 95% CI(adj) -4.1 to 15.9%). There were also no differences observed between study groups in morbidity outcomes or health-related quality of life measured at 12 months.
                The trial was terminated before the necessary sample size was collected but findings suggest that the mobile stroke team failed to confer significant long-term mortality benefit compared with general ward-based care alone. This single-blinded randomized controlled trial compared the efficacy of a reimbursable, outpatient, modified constraint-induced therapy (mCIT) protocol (half-hour therapy sessions occurring 3 days per week in which subjects used the more affected arm combined with less affected arm restriction 5 days per week for 5 hours; both of these regimens were administered during a 10-week period) with that of a time-matched exercise program for the more affected arm or a no-treatment control regimen.
                Thirty-five subjects with chronic stroke participated in the study.
                The Action Research Arm Test (ARAT), Fugl-Meyer Assessment of Motor Recovery After Stroke (FM), and Motor Activity Log (MAL) were administered to the subjects.
                After intervention, significant differences were observed on the ARAT and MAL Amount of Use and Quality of Movement scales, all in favor of the mCIT group.
                The data affirm previous findings suggesting that this reimbursable, outpatient protocol increases more affected arm use and function. Magnitude of changes was consistent with those reported in more intense protocols, such as constraint-induced therapy. Mental practice (MP) of a particular motor skill has repeatedly been shown to activate the same musculature and neural areas as physical practice of the skill. Pilot study results suggest that a rehabilitation program incorporating MP of valued motor skills in chronic stroke patients provides sufficient repetitive practice to increase affected arm use and function. This Phase 2 study compared efficacy of a rehabilitation program incorporating MP of specific arm movements to a placebo condition using randomized controlled methods and an appropriate sample size. Method- Thirty-two chronic stroke patients (mean=3.6 years) with moderate motor deficits received 30-minute therapy sessions occurring 2 days/week for 6 weeks, and emphasizing activities of daily living. Subjects randomly assigned to the experimental condition also received 30-minute MP sessions provided directly after therapy requiring daily MP of the activities of daily living; subjects assigned to the control group received the same amount of therapist interaction as the experimental group, and a sham intervention directly after therapy, consisting of relaxation. Outcomes were evaluated by a blinded rater using the Action Research Arm test and the upper extremity section of the Fugl-Meyer Assessment.
                No pre-existing group differences were found on any demographic variable or movement scale. Subjects receiving MP showed significant reductions in affected arm impairment and significant increases in daily arm function (both at the P<0.0001 level). Only patients in the group receiving MP exhibited new ability to perform valued activities.
                The results support the efficacy of programs incorporating mental practice for rehabilitating affected arm motor function in patients with chronic stroke. These changes are clinically significant. Visual feedback related to weight distribution and center-of-pressure positioning has been shown to be effective in increasing stance symmetry following stroke, although it is not clear whether functional balance ability also improves. This study compared the relative effectiveness of visual feedback training of center-of-gravity (CoG) positioning with conventional physical therapy following acute stroke.
                Forty-six people who had strokes within 80 days before the study, resulting in unilateral hemiparesis, and who were in need of balance retraining participated.
                Initially, subjects were randomly assigned to visual feedback or conventional physical therapy groups for balance retraining until 16 subjects per group were recruited. The next 14 subjects were assigned to a control group. All subjects received physical therapy and occupational therapy (regular therapy) 2 hours a day, and subjects in the 2 experimental groups received additional balance training 30 minutes a day until discharge. The visual feedback group received information about their CoG position as they shifted their weight during various activities. The conventional therapy group received verbal and tactile cues to encourage symmetrical stance and weight shifting. Static (postural sway) and activity-based measures of balance (Berg Balance Scale, gait speed, and the Timed "Up & Go" Test) were contrasted across the 3 groups at baseline, at discharge, and at 1 month following discharge using an analysis of variance for repeated measures.
                All groups demonstrated marked improvement over time for all measures of balance ability, with the greatest improvements occurring in the period from baseline to discharge. No between-group differences were detected in any of the outcome measures.
                Visual feedback or conventional balance training in addition to regular therapy affords no added benefit when offered in the early stages of rehabilitation following stroke. To assess whether the provision of computerized physiologic trend data could improve outcome in newborn infants requiring intensive care.
                Randomized, controlled trial, with subsidiary questionnaire studies.
                Tertiary neonatal intensive care unit with 12 intensive care cots.
                All infants admitted between January 1991 and September 1993 who were < or =32 wks gestation or >32 wks gestation, and ventilated for >4 hrs or asphyxiated.
                Randomization to one of four groups for first 7 days of life: A) no display of trend data; B) continuous display of trend data; C1) alternating 24-hr display of trend data, starting with display in first 24 hrs; and C2) alternating 24-hr display of trend data, starting with no display in first 24 hrs.
                The short-term effects of monitoring on patient outcome was judged by volume of colloid given, number of blood gases taken, and by measurement taken from cranial Doppler ultrasound. Medium-term measures included time ventilated, time given supplemental oxygen, death, time to death or discharge, and cranial ultrasound at discharge. Long-term outcome was assessed by neurodevelopmental status at age 1 to 4 yrs of age. Staff and parent questionnaires assessed their respective attitudes to the introduction of this technology. None of the patient outcome measures, short-, medium-, or long-term, demonstrated any significant benefit from the provision of computerized physiologic trend monitoring. Staff questionnaires demonstrated an acceptance of the system and an improved understanding of neonatal physiology as a result of computerized physiologic trends. Parent questionnaires demonstrated increased anxiety caused by the system in 11% of parents, although only 1% of parents continued to have concerns if the system were able to help their child.
                A randomized, controlled trial was unable to demonstrate any benefit to patients resulting from the introduction of a computerized physiologic trend monitoring system. Benefits of the system have been recognized, however, in subsidiary studies, staff education, and research studies. Although intervention is effective in reducing the disability associated with stroke, limited resources mean that physiotherapy services often cease by six months after stroke. The purpose of this clinical trial was to investigate the efficacy of resource-efficient physiotherapy services in improving mobility and quality of life after stroke. Twenty-six people with residual walking difficulties after stroke were randomised into an experimental or control group after discharge from physiotherapy services. The experimental group participated in a six-week, home-based mobility program. The control group participated in a six-week, home-based program of upper-limb exercises (i.e. 'sham' mobility exercises). Subjects met with the therapist for prescription of exercises only three times during the six weeks. Strategies used to offset potential problems associated with minimal subject-therapist interaction included videotaped instructions to encourage correct performance of exercises, modification of the environment and involvement of carers to enhance safety, and telephone contact and self-monitoring to promote compliance. Standing (Functional Reach), walking (MAS Item 5) and quality of life (SA-SIP30) were measured prior to, immediately after, and two months after intervention ceased by an assessor who was blinded to group allocation. Subjects in the experimental group demonstrated significant improvement in standing compared to the control group (p = 0.01) which was maintained two months after the cessation of intervention (p = 0.04). There was no difference between the groups in walking (p = 0.50) or quality of life (p = 0.70). The six-week, resource-efficient mobility program was effective in improving some of the mobility in people after discharge from stroke rehabilitation. The provision of resource-efficient programs is recommended wherever possible so that people affected by stroke may continue rehabilitation for longer.
Continuous monitoring of physiological variables for the first two to three days may improve outcomes and prevent complications. Attention to the changes in physiological variables is a key feature of a stroke unit, and can most likely be aided by continuous monitoring without complications related to immobility or to treatments triggered by the relief of abnormal physiological variables. Well-designed, high-quality studies are needed because many questions remain open and deserve further research. These include when to start continuous monitoring, when to interrupt it, which people should be given priority, and which treatments are most appropriate after the identification of abnormalities in physiological variables.