Is early initiated cardiorespiratory fitness training within a model of stroke-integrated cardiac rehabilitation safe and feasible?

OBJECTIVE: To investigate the safety and feasibility of an early initiated stroke-integrated Cardiac Rehabilitation program. METHODS: People with acute first or recurrent ischaemic stroke, admitted to Epworth HealthCare were screened for eligibility and invited to participate. In addition to usual care neurorehabilitation, participants performed 1) cardiorespiratory fitness training 3-days/week during inpatient rehabilitation (Phase 1), and/or 2) 2-days/week centre-based cardiorespiratory fitness training plus education and 1-day/week home-based cardiorespiratory fitness training for 6-weeks during outpatient rehabilitation (Phase 2). Safety was determined by the number of adverse and serious adverse events. Feasibility was determined by participant recruitment, retention, and attendance rates, adherence to exercise recommendations, and participant satisfaction. RESULTS: There were no study-related adverse or serious adverse events. Of 117 eligible stroke admissions, 62 (53%) were recruited, while 10 (16.1%) participants withdrew. Participants attended 189 of 201 (94%) scheduled cardiorespiratory fitness training sessions in Phase 1 and 341/381 (89.5%) scheduled sessions in Phase 2. Only 220/381 (58%) scheduled education sessions were attended. The minimum recommended cardiorespiratory fitness training intensity (40% heart rate reserve) and duration (20 minutes) was achieved by 57% and 55% of participants respectively during Phase 1, and 60% and 92% respectively during Phase 2. All respondents strongly agreed (69%) or agreed (31%) they would recommend the stroke-integrated Cardiac Rehabilitation program to other people with stroke. CONCLUSION: Cardiorespiratory fitness training in line with multiple clinical practice guidelines included within a model of stroke-integrated Cardiac Rehabilitation appears to be safe and feasible in the early subacute phase post-stroke.

Electroacupuncture combined with wet compress formula ameliorates upper limb dysfunction associated with stroke: A retrospective analysis of 126 cases.

OBJECTIVES: Upper limb motor dysfunction (ULMD) is one of the most common complications of ischemic stroke (IS). Electroacupuncture (EA) is a noninvasive procedure that has the potential to manage symptoms associated with IS. To improve the treatment effects of EA, our hospital performed combined treating strategy against ULMD by subjecting IS patients to both EA and external application of wet compress formula (WCF). In the current analysis, the potential improving effects of the combined treatment against ULMD were evaluated. MATERIALS AND METHODS: 126 patients with ULMD induced by IS handled with normal rehabilitation treatment, EA treatment alone, and EA combined with WCF respectively were enrolled in the current analysis. The clinicopathological information and changes in motor function assessment scales, including Visual analogue (VAS), Fugl-Meyer assessment-upper extremity (FMA-UA), and Modified Barthel index (MBI) scales were collected and the difference between different treating strategies was assessed. RESULTS: All the treating strategies improved the values of VAS, FMA-UA, and MBI scales, with combined treating strategy showing the strongest improving effects, and traditional rehabilitation strategy showing the weakest effects. Moreover, the assessment of hand and wrist motor function by FMA-UE also showed that the combined treatment strategy has significantly stronger improving effects against ULMD compared with other strategies. CONCLUSIONS: The current analysis showed that the use of external application of WCF could substantially increase the treating effects of EA on ULMD induced by IS without severe side effects, which could guide the future clinical management of motor dysfunction.

Efficacy and Safety of Vagus Nerve Stimulation in Stroke Rehabilitation: A Systematic Review and Meta-Analysis.

INTRODUCTION: Recent randomized controlled trials (RCTs) have assessed the role of vagus nerve stimulation (VNS) when paired with standard rehabilitation in stroke patients. This review aimed to evaluate the efficacy and safety of VNS as a novel treatment option for post-stroke recovery. METHODS: We searched PubMed, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials (CENTRAL), and CINAHL Plus for articles published from their date of inception to June 2021. RCTs investigating the efficacy or safety of VNS on post-stroke recovery were included. The outcomes were upper limb sensorimotor function, health-related quality of life, level of independence, cardiovascular effects, and adverse events. The risk of bias was assessed using the Cochrane risk-of-bias tool, while the certainty of the evidence was assessed using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) criteria. Review Manager 5.4 was used to conduct the meta-analysis. RESULTS: Seven RCTs (n = 236 subjects) met the eligibility criteria. Upper limb sensorimotor function, assessed by the Fugl-Meyer Assessment for Upper Extremity (FMA-UE), improved at day 1 (n = 4 RCTs; standardized mean difference [SMD] 1.01; 95% confidence interval [CI]: 0.35-1.66) and day 90 post-intervention (n = 3 RCTs; SMD 0.64; 95% CI: 0.31-0.98; moderate certainty of evidence) but not at day 30 follow-up (n = 2 RCTs; SMD 1.54; 95% CI: -0.39 to 3.46). Clinically significant upper limb sensorimotor function recovery, as defined by ≥6 points increase in FMA-UE, was significantly higher at day 1 (n = 2 RCTs; risk ratio [RR] 2.01; 95% CI: 1.02-3.94) and day 90 post-intervention (n = 2 RCTs; RR 2.14; 95% CI: 1.32-3.45; moderate certainty of the evidence). The between-group effect sizes for upper limb sensorimotor function recovery was medium to large (Hedges' g 0.535-2.659). While the level of independence improved with VNS, its impact on health-related quality of life remains unclear as this was only studied in two trials with mixed results. Generally, adverse events reported were mild and self-limiting. CONCLUSION: VNS may be an effective and safe adjunct to standard rehabilitation for post-stroke recovery; however, its clinical significance and long-term efficacy and safety remain unclear.

Ayurvedic Treatment in the Rehabilitation of Ischemic Stroke Patients in India: A Randomized Controlled Trial Study Protocol.

In patients with ischemic stroke, motor and sensory impairments are common and are associated with functional disability. Conventional physiotherapy (CP) is the primary modality of rehabilitation for post-stroke sensorimotor dysfunction. Ayurveda is a commonly practiced alternative system of medicine that offers unique rehabilitative measures for post-stroke recovery. We hypothesize that Ayurvedic rehabilitative treatment (ART) is superior to similar duration CP in improving the sensorimotor recovery of patients with ischemic stroke at 90 days after enrollment. AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A Randomized controllEd trial (RESTORE) is an investigator-initiated, multicenter, prospective, randomized, controlled, parallel-arm, blinded outcome assessment trial being conducted under the Indian Stroke Clinical Trial (INSTRuCT) Network across the four comprehensive stroke centers in India. Consecutive hemodynamically stable adult patients with their first acute ischemic stroke between 1 and 3 months from stroke onset are being randomized (1:1) into two treatment groups to receive either 1 month of ART or 1 month of CP. The primary outcome measure is the Fugl Meyer Assessment-upper extremity for physical performance at 90 days. The secondary outcomes are the modified Rankin Scale, Barthel Index, Berg Balance, and SF-36 at 90 days. The safety outcomes include a composite of irreversible morbidity and mortality. A sample size of 140 (70 in each group) patients with ischemic stroke will allow us to detect a minimal clinical important difference of 9.4 (standard deviation) with superiority margin of 5, an attrition rate of 10%, alpha of 5%, and power of 80%. This randomized trial will systematically assess the efficacy and safety of traditional ART compared to CP. The trial has been registered in the Clinical Trial Registry India (CTRI/2018/04/013379).

Effect of cyborg-type robot Hybrid Assistive Limb on patients with severe walking disability in acute stroke: A randomized controlled study.

OBJECTIVES: To investigate whether early gait training using Hybrid Assistive Limb (HAL) is feasible and improves walking and independency compared with conventional physical therapy (CPT) in patients with severe walking disability after stroke. METHODS: We conducted a single-center, randomized controlled study. Patients with first-ever stroke who had severe walking disability were included. All patients started gait training within 10 days post-stroke onset. Twenty-four patients were randomly assigned into HAL or CPT groups. Outcome measures were collected at three time points, at baseline, completion of 20 sessions of gait training (second assessment), and 3 months after the initiation of gait training. The primary outcomes were changes in motor sub-scores of the Functional Independence Measure or Functional Ambulation Category at the completion of the second assessment from baseline. RESULTS: Twenty-two patients (median age, 68 years; 12 patients in the HAL group and 10 patients in the CPT group) completed the study. There were no significant differences in primary outcomes. Apathy scale, one of the secondary outcomes, showed a decreasing trend in the HAL group (mean change of -3.8, 95% CI -8.14 to 0.475), and a slight increasing trend in the CPT group (mean change of 1.2, 95% CI -2.66 to 5.06) at the second assessment. Patients in the HAL group experienced no adverse events. CONCLUSIONS: Early gait training in patients with severe walking disability after stroke using HAL was feasible. Walking ability and independency were not improved at the completion of 20 sessions of gait training.

How little is enough? The feasibility of conducting a dose-escalation study for exercise training in people with stroke.

QUESTION: Is it feasible and safe to conduct an exercise dose-finding study in people with stroke? Is it possible to determine a minimal dose of exercise required to see clinically meaningful improvements in cardiorespiratory fitness? METHODS: Dose-escalation study. Twenty people with stroke (n=5 per cohort) who were able to walk independently participated in home-based, telehealth-supervised aerobic exercise sessions 3 d/week at moderate-vigorous intensity for 8 weeks. Dose parameters of frequency (3 d/week), intensity (55-85% of heart rate peak) and program length (8 weeks) were kept constant. The duration of exercise sessions was increased by 5 min per session from Dose 1 (10 min/session) to Dose 4 (25 min/session). Doses were escalated if safe and tolerable (< 33% of a cohort reaching a dose-limiting threshold). Doses were efficacious if ≥ 67% of a cohort increased peak oxygen consumption ≥ 2mL/kg/min. RESULTS: Target exercise doses were well adhered to, and the intervention was safe (480 exercise sessions delivered; one fall resulting in minor laceration) and tolerable (no participants met the dose-limiting threshold). None of the exercise doses met our criterion for efficacy. CONCLUSIONS: It is possible to conduct a dose-escalation trial for people with stroke. The small cohort sizes may have limited the ability to determine an efficacious minimum dose of exercise. Providing supervised exercise session at these prescribed doses via telehealth was safe. REGISTRATION: The study was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12617000460303).

Post-stroke delirium and challenges for the rehabilitation setting: A narrative review.

INTRODUCTION: Post-stroke delirium (PSD) is a common yet underrecognized complication following stroke, with its effect on stroke rehabilitation being the subject of limited attention. The objective of this narrative review is to provide an overview of core issues in PSD including epidemiology, diagnostic challenges, and management considerations, with an emphasis on the rehabilitation phase. METHODS: Ovid Medline and Google Scholar were searched through February 2023 using keywords related to delirium, rehabilitation, and the post-stroke period. Only studies conducted on adults (≥18 years) and written in the English language were included. RESULTS: PSD affects approximately 25% of stroke patients, and often persists well into the post-acute phase, with a negative impact on rehabilitation outcomes including lengths of stay, function, and cognition. Certain stroke and patient characteristics can help predict risk for PSD. The diagnosis of delirium becomes more challenging when superimposed on stroke deficits (such as attentional impairment or other cognitive, psychiatric, or behavioural disorders), leading to underdiagnosis, overdiagnosis, or misdiagnosis. Particularly in patients with post-stroke language or cognitive disorders, common screening tools are less accurate. The multidisciplinary rehabilitation team should be involved in management of PSD as rehabilitative activities can be beneficial for patients who can participate safely. Addressing barriers to effective delirium care at various levels of the health care system can improve rehabilitation trajectories for these patients. CONCLUSIONS: PSD is a disease entity commonly encountered in the rehabilitation setting, but it is challenging to diagnose and manage. New delirium screening tools and management approaches specific for the post-stroke and rehabilitation settings are needed.

The association between fatigue severity and risk of falls among middle-aged and older Australian stroke survivors.

BACKGROUND: Fatigue is a common and often debilitating symptom experienced by many stroke survivors. Significant post stroke fatigue may predispose individuals to other health complications, such as falls, which can lead to fractures and soft tissue injuries. Only limited research has examined the association between fatigue and falls in stroke survivors. METHODS: Data were obtained from the Sax Institute's 45 and Up Study, from a subset of individuals who had experienced a stroke. The Modified Fatigue Impact Scale-5-item version (MFIS-5) was used to measure the level of fatigue. A logistic regression model, adjusted for stroke characteristics and comorbidities, was used to determine the magnitude of association between change in fatigue score and odds of having had a fall. RESULTS: A total of 576 participants completed the questionnaire. A total of 214 (37.2%) participants reported having had a fall in the previous 12 months. There was a statistically significant association between fatigue scores and fall status (p < 0.001). Specifically, for every 1-point increase in the fatigue score (MFIS-5) (i.e. higher level of fatigue), the odds of a person having a fall is 1.10 times greater (AOR = 1.10; 95% CI 1.05, 1.15; p < 0.001). CONCLUSION: This study revealed an association between an increasing risk of falls with increasing severity of post stroke fatigue. Accurate detection and management of fatigue may help reduce the risk of falls and should be the focus of future research.

Spatiotemporal, kinematic and kinetic assessment of the effects of a foot drop stimulator for home-based rehabilitation of patients with chronic stroke: a randomized clinical trial.

BACKGROUND: Gait disability affects the daily lives of patients with stroke in both home and community settings. An abnormal foot-ankle position can cause instability on the supporting surface and negatively affect gait. Our research team explored the ability of a portable peroneal nerve-targeting electrical stimulator to improve gait ability by adjusting the foot-ankle position during walking in patients with chronic stroke undergoing home-based rehabilitation. METHODS: This was a double-blinded, parallel-group randomized controlled trial. Thirty-one patients with chronic stroke and ankle-foot motor impairment were randomized to receive 3 weeks of gait training, which involved using the transcutaneous peroneal nerve stimulator while walking (tPNS group; n = 16, mean age: 52.25 years), or conventional home and/or community gait training therapy (CT group; n = 15, mean age: 54.8 years). Functional assessments were performed before and after the 3-week intervention. The outcome measures included spatiotemporal gait parameters, three-dimensional kinematic and kinetic data on the ankle-foot joint, and a clinical motor and balance function assessment based on the Fugl-Meyer Assessment of Lower Extremity (FMA-LE) and Berg Balance scales (BBS). Additionally, 16 age-matched healthy adults served as a baseline control of three-dimensional gait data for both trial groups. RESULTS: The FMA-LE and BBS scores improved in both the tPNS groups (p = 0.004 and 0.001, respectively) and CT groups (p = 0.034 and 0.028, respectively) from before to after training. Participants in the tPNS group exhibited significant differences in spatiotemporal gait parameters, including double feet support, stride length, and walking speed of affected side, and the unaffected foot off within a gait cycle after training (p = 0.043, 0.017, 0.001 and 0.010, respectively). Additionally, the tPNS group exhibited significant differences in kinematic parameters, such as the ankle angle at the transverse plane (p = 0.021) and foot progression angle at the frontal plane (p = 0.009) upon initial contact, and the peak ankle joint angle at the transverse plane (p = 0.023) and foot progression angle (FPA) at the frontal and transverse planes (p = 0.032 and 0.046, respectively) during gait cycles after 3 weeks of training. CONCLUSIONS: Use of a portable tPNS device during walking tasks appeared to improve spatiotemporal gait parameters and ankle and foot angles more effectively than conventional home rehabilitation in patients with chronic stroke. Although guidelines for home-based rehabilitation training services and an increasing variety of market devices are available, no evidence for improvement of motor function and balance was superior to conventional rehabilitation. Trial registration Chictr, ChiCTR2000040137. Registered 22 November 2020, https://www.chictr.org.cn/showproj.aspx?proj=64424.

Revisiting dose and intensity of training: Opportunities to enhance recovery following stroke.

PURPOSE: Stroke is a global leading cause of adult disability with survivors often enduring persistent impairments and loss of function. Both intensity and dosage of training appear to be important factors to help restore behavior. However, current practice fails to achieve sufficient intensity and dose of training to promote meaningful recovery. The purpose of this review is to propose therapeutic solutions that can help achieve a higher dose and/or intensity of therapy. Raising awareness of these intensive, high-dose, treatment strategies might encourage clinicians to re-evaluate current practice and optimize delivery of stroke rehabilitation for maximal recovery. METHODS: Literature that tested and evaluated solutions to increase dose or intensity of training was reviewed. For each therapeutic strategy, we outline evidence of clinical benefit, supporting neurophysiological data (where available) and discuss feasibility of clinical implementation. RESULTS: Possible therapeutic solutions included constraint induced movement therapy, robotics, circuit therapy, bursts of training, gaming technologies, goal-oriented instructions, and cardiovascular exercise. CONCLUSION: Our view is that clinicians should evaluate current practice to determine how intensive high-dose training can be implemented to promote greater recovery after stroke.

Effect of early mobilization in patients with stroke and severe disturbance of consciousness: Retrospective study.

OBJECTIVES: This study aimed to investigate the effectiveness and safety of early mobilization with a physiatrist and registered therapist Operating rehabilitation (PROr) for patients with stroke and severe disturbance of consciousness (DoC). MATERIALS AND METHODS: We retrospectively screened records from patients with stroke admitted to our hospital from January 2015 to June 2021. Eligible patients with severe DoC were classified into two groups: patients who received standard rehabilitation (control group) and patients who received PROr (PROr group). We studied longitudinal change in the level of consciousness using the Japan Coma Scale (JCS) during hospital stay and compared in-hospital mortality, the incidence of respiratory complication, and modified Rankin Scale of discharge between the two groups. RESULTS: Among the 2191 patients screened for inclusion, 16 patients were included in the PROr group, and 12 patients were included in the control group. Early mobilization was more promoted in the PROr group compared to the control group, but there were no significant differences in in-hospital mortality, the incidence of respiratory complication, or modified Rankin Scale at discharge between the two groups. In patients who survived during their hospital stay, JCS scores 2 weeks after the onset of stroke and JCS scores at discharge significantly improved from the start of rehabilitation in the PROr group, but not in the control group. CONCLUSIONS: Early mobilization provided with the PROr program appears to be a safe treatment and may contribute to the improvement of consciousness level for patients with acute stroke and severe DoC.

Effects of Dual Transcranial Direct Current Stimulation and Modified Constraint-Induced Movement Therapy to Improve Upper-Limb Function after Stroke: A Double-Blinded, Pilot Randomized Controlled Trial.

BACKGROUND: Dual transcranial direct current stimulation (dual tDCS) can be combined with stroke rehabilitation interventions to promote excitatory changes in the cerebral cortex. OBJECTIVE: To investigate how the combined intervention of dual tDCS and modified constraint-induced movement therapy (mCIMT) using both anodal and cathodal stimulation affects on the recovery of upper limb function in chronic stroke patients. METHODS: This study was a double-blind randomized controlled trial. A total of 30 patients were randomly assigned to the experimental group (dual tDCS and mCIMT) or control group (sham dual tDCS and mCIMT). The experimental and control group performed mCIMT immediately after applying dual tDCS for 20 min, but the control group also performed mCIMT after applying sham tDCS for 20 min in a state where no current flows. The total intervention period was performed 5 times a week for 4 weeks. The outcome was assessed using Fugle-Meyer Assessment (FMA) Motor Activity Log (MAL) Accelerometer. RESULTS: There was a significant improvement in AOU of MAL and usage of unaffected side in the experimental group compared to the control group, and the experimental group showed more than a small effect difference compared to the control group in the effect size of all evaluations. CONCLUSIONS: This study has clinical significance in that it presents the possibility of convergence intervention that considers the therapeutic efficiency in clinical practice.

Educating Caregivers to Reduce Complications and Improve Outcomes of Stroke Patients (ECCOS) - A Cluster-Randomized Trial.

OBJECTIVES: Stroke constitutes a significant public health problem in developing countries. Caregivers provide an important support system for patient care but usually lack knowledge and skill to attend their stroke patients. We assessed whether a caregiver-directed educational intervention would reduce hospital-acquired complications and improve stroke patients' outcomes. MATERIALS AND METHODS: We randomly assigned two Neurology inpatient wards to receive either standard care or an educational intervention. The coprimary outcomes included incidence of hospital-acquired complications and in-hospital mortality. Secondary outcomes included the modified Rankin Scale and mortality at three months. RESULTS: Among 164 patients recruited, 82 received intervention, and standard care each. The mean (Standard deviation) Glasgow coma scale of patients was 11.01 (3.4), and National Institute of Health Stroke Scale was 19.17 (8.54). The incidence of complications (72 in the intervention versus 81 in the control group; p=0.56) was not different. Ten patients (12.2%) in the intervention group and 16 (19.5%) in the control group (p=0.20) died in-hospital. Twenty patients (27.8%) in the intervention and twelve (18.2%) in the control group attained modified Rankin Scale 0-2 at three months (p=0.12). The mortality at three months (20 [24.4%] in the intervention versus 25 [30.5%] in the control group) was not different (p=0.38). The intervention group had fewer complications (42 versus 68 in the control group; p=0.01) during the initial ten days of hospital stay, but adjusted analysis revealed no difference. CONCLUSION: A structured educational intervention did not reduce the incidence of hospital-acquired complications, mortality, or morbidity. However, there was a trend towards fewer complications in the initial days of hospital stay. Extended hospital stay, caregiver fatigue, and dilution of the intervention over time might be reasons for the apparent lack of effect. CLINICAL TRIAL REGISTRATION-URL: http://www.ctri.nic.in. Unique identifier: CTRI/2018/11/016312.

Comprehensive and Structured 3-month Stroke Follow-up Using the Post-stroke Checklist (The Struct-FU study): A Feasibility and Explorative Study.

BACKGROUND: There is recent evidence supporting that a comprehensive post-stroke treatment program improves outcome. However, the prevalence of stroke-related health problems and the extent of needed interventions have not been well-delineated. The Struct-FU study aims to assess the feasibility of a comprehensive stroke follow-up model and to map stroke-related problems and subsequent multidisciplinary interventions using a modified Post-stroke Checklist (PSC). METHODS: We consecutively screened all acute stroke patients at Skåne University Hospital, Sweden during an eight-month period in 2018-2019. Patients discharged to own home were eligible for inclusion. We defined a stroke-related health problem as a health- or social issue corresponding to one of the 14 items in the modified PSC, and with onset after the stroke event. Three-months post-stroke, a semi-structured interview using a 14-item modified PSC was completed to map the prevalence of stroke-related health problems, as well as any subsequent multidisciplinary stroke team interventions prompted by the visit. RESULTS: The number of included patients was 200. Of these, 165 (82.9%) completed three-month follow-up, one died, and 34 were lost to follow-up. All patients completed the full PSC, and the majority (92.7%) reported stroke-related problems identified using the PSC, with the median number being three per patient, and half having four or more problems. Patients <=65 years (n=44) presented with more stroke-related problems than patients >65 years (n=121) (5 vs. 3, p=0.003). The median number of interventions was two per patient. Doctor's interventions (changes in medication, referrals or further work-up) were done in 53% of patients, 77% needed a nurse's or other stroke team professional's intervention (tailored advice, information, audits, rehabilitation assessments) and 15% needed no intervention. Only 3.6% of patients reported other stroke-related challenges (PSC item 14) than those specified in item 1-13. CONCLUSION: We report a high burden of stroke-related health problems in community dwelling stroke patients with mild to moderate stroke. Multidisciplinary interventions were prompted in the vast majority (85%). Only 3.6% of patients reported challenges not captured with the Post-stroke Checklist, reflecting that the comprehensive approach captures the majority of stroke-related health problems, and gives a good estimate of the total stroke-related health burden for each individual.

Occlusive Disease and Upright Activity in Acute Ischemic Stroke.

The impact of out-of-bed upright activity on outcomes in ischemic stroke patients with severe extra- and intracranial stenosis or occlusion is unknown. Using ultrasound findings from a cohort recruited to A Very Early Rehabilitation Trial (AVERT) which compared higher dose very early mobilisation (VEM) to usual care (UC), we aimed to explore the association between occlusive disease and 3-month outcomes and occlusive disease-by-mobilisation treatment interactions. Participants with ischemic stroke, with carotid and transcranial Doppler ultrasounds performed ≤1 week after admission, were included in this single centre substudy in Melbourne, Australia. Reports were retrospectively reviewed to determine the degree of stenosis or presence of occlusion in the relevant arterial territory. Stenosis ≥70% extracranial or ≥50% intracranial were classified as severe or occlusion. Overall, 19% (n = 36/191) had occlusive disease in the affected circulation. About 40% (n = 14/36) with occlusive disease and 51% (n = 79/155) without had a 3-month favourable outcome (mRS 0-2) (adjusted OR0.53, CI0.17-1.67). Fourteen percent (n = 5) with occlusive disease and 4% (n = 6) without died by 3 months (adjusted OR2.52, CI0.6-10.7). Fifty percent (n = 11/22) of UC (adjusted OR0.86, CI0.23-3.2) and 21% (n = 3/14) of VEM participants (adjusted OR0.16, CI0.01-2.7) with occlusive disease had a favourable outcome. Almost 30% (n = 4) VEM participants with occlusive disease died (adjusted OR3.99, CI0.69-22.9) compared to 5% (n = 1) UC participants with occlusive disease (adjusted OR0.45, CI0.02-8.6), however numbers were small. No stenosis-by-treatment interactions were found. High quality prospective studies are needed to help guide decision making about when patients with occlusive disease should commence upright activity in acute stroke.

Higher Doses Improve Walking Recovery During Stroke Inpatient Rehabilitation.

BACKGROUND AND PURPOSE: We investigated the effect of higher therapeutic exercise doses on walking during inpatient rehabilitation, typically commencing 1 to 4 weeks poststroke. METHODS: This phase II, blinded-assessor, randomized controlled trial recruited from 6 Canadian inpatient rehabilitation units, between 2014 and 2018. Subjects (n=75; 25/group) were randomized into: control (usual care) physical therapy: typically, 1 hour, 5 days/week; Determining Optimal Post-Stroke Exercise (DOSE1): 1 hour, 5 days/week, more than double the intensity of Control (based on aerobic minutes and walking steps); and DOSE2: 2 hours, 5 days/week, more than quadruple the intensity of Control, each for 4 weeks duration. The primary outcome, walking endurance at completion of the 4-week intervention (post-evaluation), was compared across these groups using linear regression. Secondary outcomes at post-evaluation, and longitudinal outcomes at 6 and 12-month evaluations, were also analyzed. RESULTS: Both DOSE1 (mean change 61 m [95% CI, 9-113], P=0.02) and DOSE2 (mean change 58 m, 6-110, P=0.03) demonstrated greater walking endurance compared with Control at the post-evaluation. Significant improvements were also observed with DOSE2 in gait speed (5-m walk), and both DOSE groups in quality of life (EQ-5D-5 L) compared with Control. Longitudinal analyses revealed that improvements in walking endurance from the DOSE intervention were retained during the 1-year follow-up period over usual care. CONCLUSIONS: This study provides the first preliminary evidence that patients with stroke can improve their walking recovery and quality of life with higher doses of aerobic and stepping activity within a critical time period for neurological recovery. Furthermore, walking endurance benefits achieved from a 4-week intervention are retained over the first-year poststroke. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01915368.

The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.

BACKGROUND: Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation. METHODS: A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits. RESULTS: All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05). CONCLUSIONS: When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking. TRIAL REGISTRATION: NCT03499210. Prospectively registered on March 28, 2018.

Determining Maximal Tolerable Aerobic Training Intensity in the Acute Phase after Stroke: a Novel Dose Ranging Trial Protocol.

INTRODUCTION: There is strong evidence that cardiorespiratory fitness (CRF) training improves fitness and mobility after stroke. Despite the large number of studies, the most efficacious dose is yet to be determined. Furthermore, the safety of early post-stroke training, while theoretically beneficial, remains uncertain. The aim of this study is to determine the maximum safe and tolerable intensity of CRF training early post-stroke. METHODS: This is a stratified (low to moderate exercise capacity), Phase I, 5+5 dose ranging trial protocol. Participants will be recruited within one month post-stroke and stratified by their exercise-capacity (i.e. low and moderate capacity). Cohorts of five participants will perform 12 interval-based training sessions for four-weeks at a pre-determined target-intensity. The intensity will increase in each consecutive cohort, in each stratum according to pre-defined rules until the maximum safe and tolerable intensity is reached, as determined by the occurrence of dose-limiting events and occurrence of adverse events. Dose-limiting events are defined as symptoms indicative of over-training including pain and inability to perform usual activities. STUDY OUTCOME: Maximum safe and tolerable intensity of CRF training in stroke survivors with low and moderate exercise capacity. DISCUSSION: This study is a first step in the systematic development of a CRF training intervention. We believe similar dose ranging designs may be useful for development of other rehabilitation interventions in different study populations.

Cardiopulmonary exercise testing and aerobic treadmill training after stroke: Feasibility of a controlled trial.

PURPOSE: To investigate the feasibility and safety of a randomized controlled trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training in individuals in the chronic phase after stroke. METHODS: The following data were recorded: number of individuals contacted to participate, that attended in the evaluation session, and that were included (recruited) in the study; retention, attendance and adherence rates; reasons for exclusion, withdrawal, non-attendance and non-completing exercise; adverse events. RESULTS: From 230 individuals that were contacted, 39 (17%) attended the evaluation session and 22 (9.6%) were recruited in the study, 11 in each group (control and experimental). The main source of recruitment was other research projects (43.5%). The main reason for exclusion was unavailability (22%). Six out of 39 individuals (15.4%) that attended in the evaluation session were not able to perform the cardiopulmonary exercise testing. All subjects included showed a respiratory exchange ratio ≥1.0 (considered as maximal effort in the CPET). Retention rate was 81% and the main reason of withdrawal was unavailability (75%). The overall attendance rate was 88% and the main reason for non-attendance was illness/sickness (20.8%). The adherence rate was 99% and the reasons for non-completing sessions were illness/sickness (60%) or delay (40%). No serious adverse events occurred. CONCLUSION: Recruitment rate was low, retention rate was moderate, attendance and adherence rates were high. No serious adverse events occurred. It was feasible and safe to execute a randomized clinical trial that performed cardiopulmonary exercise testing and 12 weeks of aerobic treadmill training.

Comprehensive Use of Dynamic Electrical Neurostimulation and Botulinum Toxin Therapy in Patients with Post-Stroke Spasticity.

BACKGROUND: Acute cerebrovascular accident poses a threat to the health of the nation. Dynamic electric neurostimulation decreases the excitability of the receptor apparatus, optimize microcirculatory processes, analgesic and antispasmodic effects. METHODS: This article discusses the rehabilitation of 96 men and women with post-stroke spasticity, mean age of 60.51 ± 4.9 years, in the early recovery period after ischemic stroke, randomized into 4 equal groups: Group 1 received botulinum toxin therapy in combination with dynamic electric neurostimulation and basic therapy, including massage and therapeutic exercises; Group 2 -botulinum toxin therapy and basic therapy; Group 3 - dynamic electric neurostimulation and basic therapy; Group 4 - basic therapy only. Study methods included the use of the Modified Asworth Scale to assess spasticity, the Rivemead Motor Assessment test, and goniometry to assess the range of joint movements. RESULTS: During a three-week observation, it was found that the inclusion of botulinum toxin therapy and dynamic electrical neurostimulation in the standard therapy of post-stroke spasticity in patients after ischemic stroke in the early recovery period contributed to patients' recovery. CONCLUSIONS: Botulinum toxin therapy and dynamic electrical neurostimulation contributed to a more significant decrease in spasticity in the proximal and distal parts of the paretic upper extremity. It is also increased the amplitude of voluntary movements in the affected shoulder, elbow, and wrist joints, compared to the separate use of botulinum toxin therapy and dynamic electric neurostimulation as part of basic rehabilitation.