DESIGN: Retrospective observational analysis.

SETTING: 56 acute stroke hospitals in eight countries.

PARTICIPANTS: 1074 trial physiotherapists, nurses, and other clinicians.

OUTCOME MEASURES: Number of babies born during trial recruitment per trial participant recruited.

RESULTS: With 198 site recruitment years and 2104 patients recruited during AVERT, 120 babies were born to trial staff. Births led to an estimated 10% loss in time to achieve recruitment. Parental leave was linked to six trial site closures. The number of participants needed to recruit per baby born was 17.5 (95% confidence interval 14.7 to 21.0); additional trial costs associated with each birth were estimated at 5736 Australian dollars on average.

CONCLUSION: The staff absences registered in AVERT owing to parental leave led to delayed trial recruitment and increased costs, and should be considered by trial investigators when planning research and estimating budgets. However, the celebration of new life became a highlight of the annual AVERT collaborators' meetings and helped maintain a cohesive collaborative group.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry no 12606000185561.

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.

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.

OBJECTIVES: This study was conducted to gain an insight into the experiences and views of poststroke patients and their urut Melayu practitioners.

METHODS: A qualitative study design was adopted. A total of 17 semistructured in-depth interviews were carried out with poststroke patients who were undergoing urut Melayu treatment at one of the three integrated hospitals. Information was solicited from their accompanying caregivers whenever necessary. The 2 urut Melayu practitioners at the hospital were also interviewed. All the interviews were carried out in Malay by the authors, at the Traditional and Complementary Medicine unit of the relevant hospital. The interviews were audiotaped, transcribed, and coded into categories through a constant-comparison method of data analysis. Illustrative quotations were identified to supplement the narrative descriptions of the themes.

RESULTS: It was found that urut Melayu was sought by patients who had experienced stroke brought about by hypertension and postdelivery complications. They reported the unique characteristics of urut Melayu and their positive experiences with it.

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.

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.

METHODS: This is an assessor-blinded randomized control trial comparing 2 types of intervention which are game-based circuit exercise (experimental group) and conventional circuit exercise (control group). Based on sample size calculation using GPower, a total number of 82 participants will be recruited and allocated into either the experimental or the control group. Participants in the experimental group will receive a set of structured game-based exercise therapy which has the components of resistance, dynamic balance and aerobic exercises. While participants in the control group will receive a conventional circuit exercise as usually conducted by physiotherapists consisting of 6 exercise stations; cycling, repeated sit to stand, upper limb exercise, lower limb exercise, stepping up/down and walking over obstacles. Both groups will perform the given interventions for 2 times per week for 12 weeks under the supervision of 2 physiotherapists. Outcomes of the interventions will be measured using 30-second chair rise test (for lower limb strength), Dynamic Gait Index (for postural stability), 6-minute walk test (aerobic capacity), Intrinsic Motivation Inventory questionnaire (for motivation level), stroke self-efficacy questionnaire (for self-efficacy) and Short Form-36 quality of life questionnaire (for quality of life). All data will be analyzed using descriptive and inferential statistics.

DISCUSSION: This study will provide the information regarding the effectiveness of including game elements into circuit exercise training. Findings from this study will enable physiotherapists to design more innovative exercise therapy sessions to promote neuroplasticity and enhance functionality and quality of life among stroke survivors under their care.

OBJECTIVES: To assess the effectiveness of a home-based carer-assisted in comparison to hospital-based therapist-delivered therapy for community-dwelling stroke survivors.

METHODS: An assessor blinded randomised controlled trial was conducted on 91 stroke survivors (mean age 58.9±10.6 years, median time post-onset 13.0 months, 76.5% males) who had completed individual rehabilitation. The control group received hospital-based group therapy delivered by physiotherapists as out-patients and the test group was assigned to a home-based carer-assisted therapy. Targeted primary outcomes were physical functions (mobility, balance, lower limb strength and gait speed). A secondary outcome index was health-related quality of life. An intention-to-treat analysis was used to evaluate outcomes at week 12 of intervention.

RESULTS: Both therapy groups improved significantly in all the functional measures; mobility (p  0.05).

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.

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.