OBJECTIVES: To ascertain whether therapy-based rehabilitation services can influence outcome one year or more after stroke.
SEARCH STRATEGY: We searched the trials registers of the following Cochrane Review Groups: Stroke Group (last searched September 2007), Effective Practice and Organisation of Care Group (last searched October 2006) and Dementia and Cognitive Improvement Group (last searched October 2006). We also searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 4, 2006), MEDLINE (1966 to October 2006), EMBASE (1980 to October 2006), CINAHL (1982 to October 2006), AMED (1985 to October 2006), PEDro (1952 to October 2006), British Nursing Index (1993 to October 2006), DARE (1994 to October 2006), HMIC (1979 to October 2006) and NHS EED (1991 to October 2006). We also searched dissertation databases and ongoing trials and research registers, scanned reference lists and contacted researchers and experts in the field.
SELECTION CRITERIA: All randomised controlled trials of community-based stroke patients, in which at least 75% were recruited one year after stroke and received a therapy-based rehabilitation intervention that was compared with conventional care.
DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials and extracted data on a number of pre-specified outcomes. The primary outcomes were the proportion of participants who had deteriorated or were dependent in personal activities of daily living at the end of scheduled follow up.
MAIN RESULTS: We identified five trials of 487 participants that were eligible for the review. Overall, there was inconclusive evidence as to whether therapy-based rehabilitation intervention one year after stroke was able to influence any relevant patient or carer outcome. Trials varied in design, type of interventions provided, quality, and outcomes assessed.
AUTHORS' CONCLUSIONS: This review highlights the dearth of evidence investigating long-term therapy-based rehabilitation interventions for patients with stroke.
Objectives: This pilot study compared the motor evoked potential (MEP) changes using different settings of rTMS in the post-ischemic stroke patient. The goal of the study is to identify effect sizes for a further trial and evaluate safety aspects.
Methods: Eight post-stroke patients with upper limb hemiparesis for at least six months duration were studied in a tertiary hospital in Northeast Malaysia. Quasi experimental design was applied and the participants were randomised into two groups using software generated random numbers. One of the two settings: i) inhibitory setting, or ii) facilitatory setting have been applied randomly during the first meeting. The motor evoked potential (MEP) were recorded before and after application of the rTMS setting. A week later, a similar procedure will be repeated but using different setting than the first intervention. Each patient will serve as their own control. Repeated measures ANOVA test was applied to determine the effect sizes for both intervention through the options of partial eta-squared (η2p).
Result: The study observed large effect sizes (η2p > 0.14) for both rTMS settings in the lesion and non-lesion sides. For safety aspects, no minor or major side effects associated with the rTMS was reported by the participants.
Conclusions: The partial eta square of MEP value for both rTMS settings (fascilitatory and inhibitory) in both lesion and non-lesion sides represents large effect sizes. We recommend further trial to increase number of sample in order to study the effectiveness of both settings in ischemic stroke patient. Our preliminary data showed both settings may improve the MEP of the upper extremity in the ischemic stroke patient. No significant improvement noted when comparing both settings.
METHODS: Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi-centre, double-blind placebo-controlled trial which randomized subjects with acute ischemic stroke, to either MLC601 or placebo for 3 months in addition to standard stroke treatment and rehabilitation. Subjects were stratified according to whether they received or did not receive persistent rehabilitation up to month (M)3 (non- randomized allocation) and by treatment group. The modified Rankin Scale (mRS) and Barthel Index were assessed at month (M) 3, M6, M12, M18, and M24.
RESULTS: Of 880 subjects in CHIMES-E, data on rehabilitation at M3 were available in 807 (91.7%, mean age 61.8 ± 11.3 years, 36% female). After adjusting for prognostic factors of poor outcome (age, sex, pre-stroke mRS, baseline National Institute of Health Stroke Scale, and stroke onset-to-study-treatment time), subjects who received persistent rehabilitation showed consistently higher treatment effect in favor of MLC601 for all time points on mRS 0-1 dichotomy analysis (ORs 1.85 at M3, 2.18 at M6, 2.42 at M12, 1.94 at M18, 1.87 at M24), mRS ordinal analysis (ORs 1.37 at M3, 1.40 at M6, 1.53 at M12, 1.50 at M18, 1.38 at M24), and BI ≥95 dichotomy analysis (ORs 1.39 at M3, 1.95 at M6, 1.56 at M12, 1.56 at M18, 1.46 at M24) compared to those who did not receive persistent rehabilitation.
CONCLUSIONS: More subjects on MLC601 improved to functional independence compared to placebo among subjects receiving persistent rehabilitation up to M3. The larger treatment effect of MLC601 was sustained over 2 years which supports the hypothesis that MLC601 combined with rehabilitation might have beneficial and sustained effects on neuro-repair processes after stroke. There is a need for more data on the effect of combining rehabilitation programs with stroke recovery treatments.
DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).
OBJECTIVES: We assessed the effectiveness of frequent higher dose very early mobilisation (VEM) after stroke.
DESIGN: We conducted a parallel-group, single-blind, prospective randomised controlled trial with blinded end-point assessment using a web-based computer-generated stratified randomisation.
SETTING: The trial took place in 56 acute stroke units in five countries.
PARTICIPANTS: We included adult patients with a first or recurrent stroke who met physiological inclusion criteria.
INTERVENTIONS: Patients received either usual stroke unit care (UC) or UC plus VEM commencing within 24 hours of stroke.
MAIN OUTCOME MEASURES: The primary outcome was good recovery [modified Rankin scale (mRS) score of 0-2] 3 months after stroke. Secondary outcomes at 3 months were the mRS, time to achieve walking 50 m, serious adverse events, quality of life (QoL) and costs at 12 months. Tertiary outcomes included a dose-response analysis.
DATA SOURCES: Patients, outcome assessors and investigators involved in the trial were blinded to treatment allocation.
RESULTS: We recruited 2104 (UK, n = 610; Australasia, n = 1494) patients: 1054 allocated to VEM and 1050 to UC. Intervention protocol targets were achieved. Compared with UC, VEM patients mobilised 4.8 hours [95% confidence interval (CI) 4.1 to 5.7 hours; p stroke may be associated with a more favourable outcome.
FUTURE WORK: These results informed a new trial proposal [A Very Early Rehabilitation Trial - DOSE (AVERT-DOSE)] aiming to determine the optimal frequency and dose of EM.
TRIAL REGISTRATION: The trial is registered with the Australian New Zealand Clinical Trials Registry number ACTRN12606000185561, Current Controlled Trials ISRCTN98129255 and ISRCTN98129255.
FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 54. See the NIHR Journals Library website for further project information. Funding was also received from the National Health and Medical Research Council Australia, Singapore Health, Chest Heart and Stroke Scotland, Northern Ireland Chest Heart and Stroke, and the Stroke Association. In addition, National Health and Medical Research Council fellowship funding was provided to Julie Bernhardt (1058635), who also received fellowship funding from the Australia Research Council (0991086) and the National Heart Foundation (G04M1571). The Florey Institute of Neuroscience and Mental Health, which hosted the trial, acknowledges the support received from the Victorian Government via the Operational Infrastructure Support Scheme.
METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are HBT (experimental group) and usual practice (UP) (control group). Based on sample size calculation using GPower, a total number of 42 participants will be recruited and allocated into either the HBT or the UP group. Participants in HBT group will receive a set of structured exercise therapy consisting of progressive strengthening, balance and task-related exercises. While participants in UP group will receive a usual "intervention" practised by rehabilitation professional prior to discharging stroke patients from their care. Both groups are advised to perform the given interventions for 3 times per week for 12 weeks under the supervision of their caregiver. Outcomes of interventions will be measured using timed up and go test (for mobility), ten-meter walk test (for gait speed), stroke self-efficacy questionnaire (for self-efficacy) and hospital anxiety and depression scale (for anxiety level). All data will be analyzed using descriptive and inferential statistics.
DISCUSSION: This study will provide the information on the effectiveness of HBT in comparison to UP among stroke population who are discharged from rehabilitation. Findings from the study will enable rehabilitation professionals to design effective discharge care plan for stroke survivors in combating functional decline when no longer receiving hospital-based therapy.
TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry, ACTRN12619001182189 (last updated 22/11/2019).
AIM: The aim of this study was to classify the primary outcomes used in Cochrane Systematic Reviews (CSRs) into the ICF domains of functioning; to describe the differences in primary outcomes in reviews related to rehabilitation intervention and non-rehabilitation intervention; and to describe the trend of outcome selections according year of publication.
DESIGN: Methodological paper.
POPULATION: Adult stroke population.
METHODS: We analyzed the primary outcomes used in the CSRs published by the Cochrane Stroke Review Group up to December 2017. The primary outcomes were extracted and classified into the ICF domains of functioning (body functions, body structures and activity and participation).
RESULTS: One hundred and seventy-four papers with 216 primary outcomes were included in this analysis. Less than half (102/216, 47.2%) of the outcomes could be classified into the ICF domains of functioning. For the outcomes that could be classified into the ICF domains, the majority (72/102, 70.5%) were in the activity and participation domain, followed by body functions (26/102, 25.5%) and body structures (4/102, 4.0%). Of the outcomes that could not be classified into the ICF domains (N.=114), death (81/114, 71.1%) and recurrent stroke (21/114,18.4%) formed the majority of the outcome. There were 75 CSRs on rehabilitation related interventions; the majority of the outcomes (75/97, 77.3%) used in rehabilitation related CSRs could be classified into the ICF framework with more than half (49/75, 65.3%) in the activity and participation domain.
CONCLUSIONS: The majority of the primary outcomes selected by the Cochrane Stroke Review Group in their CSRs could not be classified into the ICF domains of functioning. Death and recurrence of vascular events remains the major outcome of interest. In rehabilitation related interventions, activity and participation domain is the functioning domain most commonly used.
CLINICAL REHABILITATION IMPACT: The systematic use of patients-centered ICF-based outcomes in CSRs could help the application of evidence in clinical decision making.
DESIGN: This post hoc descriptive exploration of data from the large international very early rehabilitation trial (A Very Early Rehabilitation Trial (AVERT)) examined the four common post acute rehabilitation pathways (inpatient rehabilitation, home with community rehabilitation, inpatient rehabilitation then community rehabilitation and home with no rehabilitation) experienced by participants in the 3 months post stroke and describes their 12-month outcomes.
SETTING: Hospital stroke units in AUS, UK and SE Asia.
PARTICIPANTS: Patients who had an acute stroke recruited within 24 hours who were ≤65 years.
RESULTS: 668 participants were ≤65 years; 99% lived independently, and 88% no disability (modified Rankin Score (mRS)=0) prior to stroke. We had complete data for 12-month outcomes for n=631 (94%). The proportion receiving inpatient rehabilitation was higher in AUS than other regions (AUS 52%; UK 25%; SE Asia 23%), whereas the UK had higher community rehabilitation (UK 65%; AUS 61%; SE Asia 39%). At 12 months, 70% had no or little disability (mRS 0-2), 44% were depressed, 28% rated quality of life as poor or worse than death. For those working prior to stroke (n=228), only 57% had returned to work. A noteworthy number of working age survivors received no rehabilitation services within 3 months post stroke.
CONCLUSIONS: There was considerable variation in rehabilitation pathways and post acute service use across the three regions. At 12 months, there were high rates of depression, poor quality of life and low rates of return to work.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561).
METHODS: This cross-sectional study involved 65 stroke survivors with UL dysfunction (mean (SD) age = 64.83 (8.05) years, mean (SD) post-stroke duration 41.62 (35.24) months) who attended community-based rehabilitation program. Upper limb functionality was assessed using the UL items of Stroke Specific Quality of Life Scale (SSQOL), the Lawton Instrumental Activities of Daily Living (IADL) Scale and the Jebsen-Taylor Hand Function Test (JTHFT). The stroke survivors' performance in completing JTHFT using their affected dominant hand was compared with standard norms.
RESULTS: The three most affected UL daily living tasks were writing (64.7%, n=42), opening a jar (63.1%, n=41) and putting on socks (58.5%, n=38). As for IADL, the mean (SD) score of Lawton scale was 3.26 (2.41), with more than 50% unable to handle finance, do the laundry and prepare meals for themselves. Performances of stroke survivors were much slower than normal population in all tasks of JTHFT (p<0.05), with largest speed difference demonstrated for 'stacking objects' task (mean difference 43.24 secs (p=0.003) and 24.57 (p<0.001) in males and females, respectively.
CONCLUSION: UL functions are significantly impaired among stroke survivors despite undergoing rehabilitation. Rehabilitation professionals should prioritize highly problematic tasks when retraining UL for greater post-stroke functionality.
METHODS: This was a cross-sectional study of stroke survivors attending post-stroke care clinics in three public hospitals in the states of Pahang and Terengganu, Malaysia. The HRQoL was assessed by EuroQol-5 dimension-5 levels. Data on socio-demographic, clinical profiles, malnutrition risk, and physical activity level were collected through an interviewer-administered survey. Descriptive analyses for HRQoL profiles and multiple logistic regression analyses for its associated factors were performed. Crude and adjusted odds ratios were reported.
RESULTS: A total of 366 stroke survivors were recruited with a mean age of 59 ± 11 years. The most -commonly reported health problems were mobility (85%), followed by usual activities (82%), pain/discomfort (63%), anxiety/depression (51%) and self-care (41%). The mean of the EQ visual analogue scale and the median of the EQ5D summary index was reported at 60.3 ± 14.2 and 0.67 ± 0.37, respectively. Malnutrition risk (mobility, usual activities, and self-care), wheelchair users (self-care and usual activities), speech impairment (usual activities and pain/discomfort), number of stroke episodes (self-care and pain/discomfort), body mass index, physical activity level and types of strokes (usual activities), age and use of a proxy (anxiety/depression), working and smoking status (mobility), were factors associated with either single or multiple dimensions of HRQoL.
CONCLUSION: Routine malnutrition screening, tailored program for speech therapy, prevention of recurrent stroke, and physical activity promotion should be addressed and further reinforced in current rehabilitation interventions to improve the HRQoL among stroke survivors in Malaysia.
FINDINGS AND CONCLUSIONS: Stroke recovery involves adapting to new limitations and discovering the support necessary to live life. These changes are influenced by a range of environmental factors. Healthcare professionals need to support stroke patients in identifying challenges and work to find innovative ways to address them. Stroke survivors may benefit from the use of an assistive device beyond its clinical function to participate purposefully in activities of daily living. Implications for Rehabilitation Stroke is a cause of disability that limits everyday activities and reduces social participation. Assistive devices help achieve independence, social inclusion and shape stroke recovery. Individuals with disabilities in low and middle income countries often do not have access to assistive devices and resort to innovative solutions that are purpose built. Stroke recovery involves adapting to new limitations and discovering the support necessary to live life as best as possible.