Cognitive behavioral psychotherapy for depression following stroke: a randomized controlled trial. Expanding the role of the stroke nurse: a pragmatic clinical trial. A very early rehabilitation trial for stroke (AVERT): phase II safety and feasibility. A randomized controlled trial of a stroke rehabilitation ward. Recovery from disability after stroke as a target for a behavioural intervention: results of a randomized controlled trial. Very early rehabilitation or intensive telemetry after stroke: a pilot randomised trial. A randomized controlled trial of modified constraint-induced movement therapy for elderly stroke survivors: changes in motor impairment, daily functioning, and quality of life. A randomized, controlled, a single-blind trial of nutritional supplementation after acute stroke. The effectiveness of community-based rehabilitation for stroke patients who remain at home: a pilot randomized trial.
There is inconclusive evidence of the effectiveness of psychological interventions for depression after stroke. We report the results from a randomized controlled trial of cognitive behavioral therapy (CBT).
                Stroke patients admitted to hospital were invited to complete mood questionnaires 1, 3 and 6 months after stroke. Patients who were depressed were invited to take part in a trial and randomly allocated to receive CBT (n=39), an attention placebo intervention (n= 43), or standard care (n=41). Outcome assessments were undertaken at 3 and 6 months after recruitment, on the Beck Depression Inventory, Wakefield Depression Inventory, Extended Activities of Daily Living scale, London Handicap Scale, and a rating of satisfaction with care.
                There were no significant differences between the groups in patients' mood, independence in instrumental activities of daily living, handicap, or satisfaction with care.
                CBT in the treatment of depression following stroke was found to be ineffective in this study. However, because of the small sample size, method of recruitment, and selection criteria, further randomized trials are required. This paper reports a study evaluating whether expanding a specialist nursing role to provide outreach education and support to stroke patients and carers after discharge from hospital is effective in promoting recovery.
                Building therapeutic relationships with patients and carers is a key component of the nursing role in stroke rehabilitation, although this is limited by the constraints of service organization.
                A pragmatic randomized controlled trial was undertaken. Patients with a diagnosis of stroke were randomized to receive continued support from a stroke nurse (n = 87) or usual care and follow-up (n = 89) after discharge from hospital. Patients were recruited from two hospitals in the north-west of England from November 1999 to April 2001. Patient dependence (Barthel Index), general health (Nottingham Health Profile), activities of living (Frenchay Activity of Living Index), depression (Beck Depression Inventory) and carer strain (Carer Strain Index) were assessed at 3 and 12 months after stroke.
                The continued intervention of a stroke nurse after discharge was associated with improved patient perceptions of general health at 12 months (median difference 42.6, P = 0.012), and in particular reduced negative emotional reaction (P = 0.037) and perceived social isolation (P = 0.002). In addition, the intervention reduced carer strain at 3 months (P = 0.045), and reduced deterioration in physical dependence from 3 to 12 months (P = 0.049).
                The provision of continued intervention from a stroke nurse after discharge from hospital, focusing on education and support, has tangible benefits for patients and carers. Very early rehabilitation, with an emphasis on mobilization, may contribute to improved outcomes after stroke. We hypothesized that a very early rehabilitation protocol would be safe and feasible.
                We performed a randomized, controlled trial with blinded outcome assessment. Patients at <24 hours after stroke were recruited from 2 Melbourne metropolitan stroke units. Patients were randomly assigned to receive standard care (SC) or SC plus very early mobilization (VEM) until discharge or 14 days (whichever was sooner). The primary safety outcome was the number of deaths at 3 months. The primary feasibility outcome was a higher "dose" of mobilization achieved in VEM. Secondary safety outcomes included adverse events (including falls and early neurologic deterioration), compliance with physiologic monitoring criteria, and patient fatigue after interventions. Secondary feasibility outcomes included "contamination" of standard care.
                Overall, 18% of patients screened were suitable for recruitment. Seventy-one patients were recruited and randomized, with 2 dropouts by 12 months. The majority experienced ischemic strokes (87%). The group mean+/-SD age was 74.7+/-12.5 years, and 58% (n=41) had a National Institutes of Health Stroke Scale score >7. There was no significant difference in the number of deaths between groups (SC, 3 of 33; VEM, 8 of 38; P=0.20). Almost all deaths occurred in patients with severe stroke. Secondary safety outcomes were similar between groups. The intervention protocol was successfully delivered, achieving VEM dose targets (double SC, P=0.003) and faster time to first mobilization (P<0.001).
                VEM of patients within 24 hours of acute stroke appears safe and feasible. Intervention efficacy and cost-effectiveness are currently being tested in a large randomized, controlled trial. In S.E. Kent, during 1978 and 1979, 225 patients, representing 228 occurrences of hemiplegia, were referred to a new 20-bed stroke rehabilitation ward. These patients were randomly allocated to treatment in the special ward (group A 112 strokes) or to remain in conventional treatment locations (group C 116 strokes); the two groups were closely similar, except for the initial level of consciousness. Survivors were observed at four-month intervals to one year. There are indications of benefit for patients in group A by comparison with Group C in terms of treatment received (number treated by remedial therapists, the extent of treatment, and the arrangements for after-care), and in outcome (survival and the proportion returned to the community). The direction of the trend of advantage is consistent with another recent controlled trial, although not all modes of improvement are identical in the two trials. It is suggested that every health district should develop a comprehensive policy of stroke management. Disability following stroke is highly prevalent and is predicted by psychological variables such as control cognitions and emotions, in addition to clinical variables. This study evaluated the effectiveness of a workbook-based intervention, designed to change cognitions about control, in improving outcomes for patients and their carers.
                At discharge, stroke patients were randomly allocated (with their carers) to a 5-week intervention (n = 103) or control (normal care: n = 100). The main outcome (at 6 months) was recovery from disability using a performance measure, with distress and satisfaction as additional outcomes.
                The intervention group showed significantly better disability recovery, allowing for initial levels of disability, than those in the control group, F(1,201) = 5.61, p = 0.019. Groups did not differ in distress or satisfaction with care for patients or carers. The only psychological process variable improved by the intervention was Confidence in Recovery but this did not mediate the effects on recovery.
                A large proportion of intervention participants did not complete the workbook tasks. This was perhaps associated with the fairly low level of personal contact with workbook providers. The modest success of this intervention suggests that it may be possible to develop effective behavioural interventions to enhance recovery from disability in stroke patients. 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. To examine the benefits of modified constraint-induced movement therapy (mCIMT) on motor function, daily function, and health-related quality of life (HRQOL) in elderly stroke survivors.
                Two-group randomized controlled trial, with pretreatment and posttreatment measures.
                Rehabilitation clinics.
                Twenty-six elderly stroke patients (mean age, 72 y) with 0.5 to 31 months postonset of a first-ever cerebrovascular accident.
                Twenty-six patients received either mCIMT (restraint of the unaffected limb combined with intensive training of the affected limb) or traditional rehabilitation for a period of 3 weeks.
                Outcome measures included the Fugl-Meyer Assessment (FMA), FIM instrument, Motor Activity Log (MAL), and Stroke Impact Scale (SIS). The FMA evaluated the severity of motor impairment; the FIM instrument and MAL reported daily function; and the SIS detected HRQOL.
                The mCIMT group exhibited significantly greater improvements in motor function, daily function, and the physical domain of HRQOL than the traditional rehabilitation group. Patients in the mCIMT group perceived significantly greater percent of recovery after treatment than patients in the traditional rehabilitation group.
                These findings suggest mCIMT is a promising intervention for improving motor function, daily function, and physical aspects of HRQOL in elderly patients with stroke. The mCIMT was well tolerated by the elderly patients even though it is a rigorous training program. Although stroke patients who do not have difficulty swallowing may be at risk of undernutrition and worsening nutritional status during hospitalization, optimum methods for nutrition intervention in stroke patients have not been established.
                To examine the feasibility of enteral sip feeding as an effective nutrition intervention after acute stroke.
                Forty-two acute ischemic stroke inpatients with impaired nutritional status who did not have difficulty swallowing within 1 week after the stroke were entered into a single-blind, randomized, controlled, prospective study of enteral sip feeding. Twenty-one patients were randomized to receive daily oral food supplements for 4 weeks in addition to the hospital food, and 21 patients received only the hospital food for the same period. Main outcome measures were energy and protein intakes during the intervention period, change in nutritional status, disability, infective complications, length of stay, and mortality during hospitalization and at 3 months.
                Two patients, one from each group, were lost to follow-up immediately after randomization. Twenty patients received oral nutritional supplementation. The energy intake was significantly greater in the supplemented group: 1807 +/- 318 vs 1084 +/- 343 kcal/d (mean +/- SD; p < .0001) (estimated treatment effect, 723 kcal/d; 95% confidence interval [CI], 498 to 947), as was protein intake: 65.1 +/- 13.8 vs 44.1 +/- 12.8 g/d (p < .001) (estimated treatment effect, 21.0 g/d; 95% CI, 11.7 to 30.3). There also were significant differences between the two groups in the changes in serum albumin and serum iron concentrations between randomization and at follow-up. There was a trend to lower mortality at 3 months in the supplemented group with two deaths (10%) compared with seven deaths (35%) in the control group (p = .127, relative risk, 0.29; 95% CI, 0.07 to 1.21).
                This study suggests that enteral sip feeding is effective in improving nutritional intake and status in stroke patients who do not have swallowing difficulties. There also may be some beneficial effects on clinical outcome, but larger studies are required to confirm this observation and define more precisely the magnitude of any favorable effects. To assess the effectiveness of community-based rehabilitation for stroke patients who were not admitted to hospital in South London.
                Randomized controlled trial.
                Patients' homes in South London.
                Stroke patients not admitted to hospital after a stroke.
                Rehabilitation at home by rehabilitation team for up to three months or usual care.
                The primary outcome measure was the Barthel score. Secondary measures included the Motricity Index, Rivermead ADL, Hospital Anxiety and Depression score and Nottingham Health Profile.
                Forty-three patients who remained at home were randomized to rehabilitation team (23) or 'usual' care (20). The mean number of physiotherapy sessions was three (range 1-14) for the rehabilitation team group and two for the usual care group. Patients (with a deficit) in the rehabilitation arm of the trial were more likely to receive occupational, physical and speech therapy than those in the control arm (p = 0.03, 0.01 and 0.008, respectively). For those patients actually receiving therapy, there was no evidence that the amount received differed between the groups. However, the number of patients in each of these comparisons was very small. The outcome for patients in the rehabilitation team arm of the trial was nonsignificantly higher (0.05 < p < 0.2) than for those in the control arm for the areas of Nottingham Health Profile, anxiety, depression, caregiver strain and the proportion of patients living at home. Based on the data observed here, a trial with approximately 150 patients in each arm would be needed to have adequate power to detect a 33% difference between intervention and control groups in these outcomes.
                Community therapy support for patients not admitted to hospital is feasible but to determine whether it is cost- or clinically effective would require trials of adequate size.
There is insufficient evidence available to guide the management of fatigue after stroke. Further trials are required.