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.

Effects of trunk exercises using virtual reality technology on trunk performance and impairment post stroke: a systematic review and meta-analysis.

OBJECTIVE: To systematically explore the effects of trunk exercises using virtual reality technology compared to conventional exercises for trunk impairment in patients with subacute and chronic strokes. METHODS: A comprehensive search of literature published from inception until December 2022 was conducted using PubMed, Cochrane Library, Web of Science, Scopus, IEEE, and the Physiotherapy Evidence Database (PEDro). The inclusion criteria encompassed all randomized controlled trials (RCT) published in the English language involving adults who had had strokes and the evaluation of the effectiveness of virtual reality -based trunk exercises in reducing trunk impairment post stroke as measured by the trunk control test (TCT) and/or the trunk impairment scale (TIS) compared to conventional trunk exercises. RESULT: A total of 397 studies were retrieved, and six studies were included in the current analysis. A random-effects meta-analysis of six studies indicated that video games had a very large, significant effect (SMD = 1.11; 95%, P < 0.0001) on the delivery of trunk exercises to reduce trunk impairment post stroke at both the subacute and chronic stages. CONCLUSION: The study findings indicate that trunk exercises using virtual reality have a highly significant effect on reducing trunk impairment in patients with subacute and chronic stroke. Large RCTs are needed to study the effects of virtual reality trunk exercises on the acute, subacute, and chronic stages of 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.

Application of rectal balloon ice water stimulation for the rehabilitation of stroke patients with neurogenic bowel dysfunction.

BACKGROUND: Neurogenic bowel dysfunction (NBD) is a common complication in stroke patients. OBJECTIVE: To investigate the effect of rectal balloon ice water stimulation on the rehabilitation of patients with NBD after a cerebral stroke. METHODS: Forty stroke patients with NBD were selected between March and August 2022 and randomly divided into a study group (n = 20) and a control group (n = 20). Based on routine rehabilitation training, rectal balloon ice water stimulation or finger rectal stimulation were performed on the study or control group, respectively. After two weeks, the changes in the NBD, self-rating depression scale (SDS) and self-rating anxiety scale (SAS) scores were compared between the two groups. RESULTS: Before the intervention, there were no significant differences in age, sex ratio, and NBD, SDS and SAS scores between the two groups (p > 0.05). The NBD, SDS and SAS scores of both groups were significantly decreased following intervention (p < 0.05). After 2 weeks of intervention, the NBD score of the study group was significantly lower than that of the control group (5.50±1.28 vs 6.45±1.05; p = 0.014). The SDS score of the study group was lower than that of the control group, and the difference was statistically significant (32.30±2.81 vs 44.05±2.19; p = 0.014). The study group also had significantly lower SAS scores than the control group (p = 0.024). In addition, the incidence of dizziness, headaches, nausea, vomiting and abdominal pain and distension in the study group was significantly lower than in the control group (p < 0.05). CONCLUSION: Rectal balloon ice water stimulation can significantly improve stroke patients with NBD's intestinal function and psychological status.

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.

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).

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.

Focal vibration of the plantarflexor and dorsiflexor muscles improves poststroke spasticity: a randomized single-blind controlled trial.

BACKGROUND: Post-stroke spasticity is a cause of gait dysfunction and disability. Focal vibration (FV) of agonist-antagonist upper limb muscle pairs reduces flexor spasticity; however, its effects on ankle plantarflexor spasticity are uncertain. OBJECTIVE: To assess the effects of focal vibration administered by a trained operator to the ankle plantarflexor and dorsiflexor muscles on post-stroke lower limb spasticity. METHODS: A randomized, single-blind controlled trial of 64 participants with stroke and plantarflexor spasticity assigned to 3 groups by centralized, computer-generated randomization (1:1:1): 1) physiotherapy alone (CON), 2) physiotherapy+gastrocnemius vibration (FV_GM) and 3) physiotherapy+tibialis anterior vibration (FV_TA). Physiotherapists and assessors were blinded to group assignment. The experimental groups underwent 15, 20-min vibration sessions at 40 Hz. We performed evaluations at baseline and after the final treatment: Modified Ashworth Scale (MAS), Clonus scale, Functional Ambulation Categories (FAC), Fugl-Meyer Assessment - Lower Extremity (FMA_LE), Modified Barthel Index (MBI), and electromyography and ultrasound elastography. Primary outcome was remission rate (number and proportion of participants) of the MAS. RESULTS: MAS remission rate was higher in FV_GM and FV_TA than CON groups (CON vs. FV_GM: p=0.009, odds ratio 0.15 [95% confidence interval 0.03-0.67]; CON vs. FV_TA: p=0.002, 0.12 [0.03-0.51]). Remission rate was higher in the experimental than CON groups for the Clonus scale (CON vs. FV_GM: p<0.001, OR 0.07 [95% CI 0.01-0.31]; CON vs. FV_TA: p=0.006, 0.14 [95% CI 0.03-0.61]). FAC remission rate was higher in the FV_TA than the CON (p=0.009, 0.18 [0.05-0.68]) and FV_GM (p=0.014, 0.27 [0.07-0.99]) groups. Ultrasound variables of the paretic medial gastrocnemius decreased more in FV_GM than CON and FV_TA groups (shear modulus: p=0.006; shear wave velocity: p=0.008). CONCLUSIONS: Focal vibration reduced post-stroke spasticity of the plantarflexor muscles. Vibration of the tibialis anterior improved ambulation more than vibration of the gastrocnemius or physiotherapy alone. Gastrocnemius vibration may reduce spasticity by changing muscle stiffness.

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.

High-Definition Transcranial Direct Current with Electrical Theta Burst on Post-Stroke Motor Rehabilitation: A Pilot Randomized Controlled Trial.

BACKGROUND: High-definition transcranial electrical theta burst superimposing direct current stimulation (HD-tDCS-eTBS) not only incorporates the therapeutic advantages of tDCS and TBS but enhances stimulation focality and practicality. However, the applicability of this innovative neuromodulatory device in post-stroke rehabilitation remains uncertain. OBJECTIVE: This study aimed to assess the efficacy and safety of the HD-tDCS-eTBS on upper extremity (UE) motor function in patients with chronic stroke. METHODS: A patient-blinded, randomized controlled study was conducted. Twenty-four participants were randomly assigned into either the active HD-tDCS-eTBS group or sham HD-tDCS-eTBS group. Both groups received 20 minutes of active/sham HD-tDCS-eTBS combined with 30 minutes of conventional UE rehabilitation each time, 3 times a week for 4 weeks. Outcome measures including the Fugl-Meyer Assessment of Upper Extremity, Wolf Motor Function Test, Jebsen-Taylor Hand Function Test, Finger-Nose Test, and Modified Ashworth Scale were assessed before and immediately after the intervention period. RESULTS: Spasticity of shoulder adductor (P = .05), elbow extensor (P = .04), and thumb flexor (P < .01) were significantly reduced in the active HD-tDCS-eTBS group versus the sham group. Nonsignificant trends in the improvements of most other outcome measures were in favor of the active HD-tDCS-eTBS group with moderate to large effect sizes (P = .06-.26, ηp2 = 0.06-0.16). No severe adverse events except for slight skin redness under the stimulus electrode was detected after the HD-tDCS-eTBS. CONCLUSIONS: Our findings support that HD-tDCS-eTBS is safe and has therapeutic potential for post-stroke UE motor rehabilitation. TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT04278105).

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.

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.

Review of the effectiveness of neuromuscular electrical stimulation in the treatment of dysphagia - an update.

Background: Neuromuscular electrical stimulation (NMES) has been used as a treatment option in the therapy of dysphagia for several years. In a previous review of the literature, it was concluded that NMES might be a valuable adjunct in patients with dysphagia and in patients with vocal fold paresis. However, due to different stimulation protocols, electrode positioning and various underlying pathological conditions, it was difficult to compare the studies which were identified and it was concluded that more empirical data is needed to fully understand the benefits provided by NMES. The purpose of this systematic review is, therefore, to evaluate recent studies regarding a potential effectiveness of transcutaneous NMES applied to the anterior neck as a treatment for dysphagia considering these different aspects. Method: For this systematic review, a selective literature research in PubMed has been carried out on 5th May 2021 using the terms electrical stimulation AND dysphagia and screened for inclusion criteria by two reviewers in Rayyan. The search resulted in 62 hits. Results: Studies were excluded due to their publication language; because they did not meet inclusion criteria; because the topical focus was a different one; or because they did not qualify as level 2 studies. Eighteen studies were identified with varying patient groups, stimulation protocols, electrode placement and therapy settings. However, 16 studies have reported of beneficial outcomes in relation with NMES. Discussion: The purpose of this systematic review was to evaluate the most recent studies regarding a potential effectiveness of NMES as a treatment for oropharyngeal dysphagia considering different aspects. It could generally be concluded that there is a considerable amount of level 2 studies which suggest that NMES is an effective treatment option, especially when combined with TDT for patients with dysphagia after stroke and patients with Parkinson's disease, or with different kinds of brain injuries. Further research is still necessary in order to clarify which stimulation protocols, parameters and therapy settings are most beneficial for certain patient groups and degrees of impairment.

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.

Effects of robot-assisted therapy on upper limb and cognitive function in patients with stroke: study protocol of a randomized controlled study.

BACKGROUND: Impairments in upper limb motor function and cognitive ability are major health problems experienced by stroke patients, necessitating the development of novel and effective treatment options in stroke care. The aim of this study is to examine the effects of robot-assisted therapy on improving upper limb and cognitive functions in stroke patients. METHODS: This will be a single-blinded, 2-arm, parallel design, randomized controlled trial which will include a sample size of 86 acute and subacute stroke patients to be recruited from a single clinical hospital in Shanghai, China. Upon qualifying the study eligibility, participants will be randomly assigned to receive either robot-assisted therapy or conventional therapy with both interventions being conducted over a 6-week period in a clinical rehabilitation setting. In addition to comprehensive rehabilitation, the robot-assisted therapy group will receive a 30-min Armguider robot-assisted therapy intervention 5 days a week. Primary efficacy outcomes will include Fugl-Meyer Assessment for Upper Extremity (FMA-UE) and Mini-Mental Status Examination (MMSE). Other secondary outcomes will include Trail Making Test (TMT), Auditory Verbal Learning Test (AVLT), Digit Symbol Substitution Test (DSST), and Rey-Osterrieth Complex Figure Test (ROCFT). All trial outcomes will be assessed at baseline and at 6-week follow-up. Intention-to-treat analyses will be performed to examine changes from baseline in the outcomes. Adverse events will be monitored throughout the trial period. DISCUSSION: This will be the first randomized controlled trial aimed at examining the effects of robot-assisted therapy on upper limb and cognitive functions in acute and subacute stroke patients. Findings from the study will contribute to our understanding of using a novel robotic rehabilitation approach to stroke care and rehabilitation. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2100050856 . Registered on 5 September 2021.

Muscle Energy Technique plus Neurac Method in Stroke Patients with Hemiplegia Complicated by Diabetes Mellitus and Assessment of Quality of Life.

Objective: To analyze the role of muscle energy technique (MET) plus Neurac method in stroke patients with hemiplegia complicated by diabetes mellitus and the impact on quality of life. Methods: From January 2021 to December 2021, 100 stroke patients with hemiplegia complicated by diabetes mellitus treated in our institution and assessed for eligibility were recruited and randomly assigned (1 : 3) via the random sampling method to either the conventional rehabilitation group or the experimental group. The patients in the experimental group were randomized (1 : 1 : 1) into either the MET group (receives MET), the Neurac group (receives Neurac), or the joint group (receives MET plus Neurac). The primary endpoint is the clinical efficacy, and the second endpoint is the quality of life. Results: The eligible patients had similar pretreatment Barthel index scores, Visual Analogue Scale (VAS) scores, Berg balance scale (BBS) scores, Tinetti scores, Fugl-Meyer scores, and quality of life (QoL) scores (P > 0.05). The treatment herein achieved significant improvements in Barthel index scores, VAS scores (2.71 ± 0.28), BBS scores, Tinetti scores, Fugl-Meyer scores, and QoL scores (99.67 ± 10.62), and MET plus Neurac method obtained the best results versus both the conventional rehabilitation and monotherapy of either MET or Neurac (P < 0.05). Conclusion: Neurac method plus MET improves the independent mobility of stroke patients with hemiplegia and diabetes, relieves pain, enhances balance and stability, mitigates limb dysfunction, and boosts patients' quality of life, so it is worthy of clinical application.

Would integrated Western and traditional Chinese medicine have more benefits for stroke rehabilitation? A systematic review and meta-analysis.

BACKGROUND: Stroke is a major cause of death or long-term disability worldwide. Many patients with stroke receive integrative therapy consisting of Western medicine (WM) and routine rehabilitation in conjunction with Chinese medicine (CM), such as acupuncture and Chinese herbal medicine. However, there is no available evidence on the effectiveness of the combined use of WM and CM interventions in stroke rehabilitation. AIMS: The purpose of this meta-analysis is to evaluate the results of all individual studies to assess the combined use of CM and WM in stroke rehabilitation compared with WM only. METHODS: The Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed. MEDLINE, EMBASE, Cochrane and China National Knowledge Infrastructure (CNKI) were searched. The included outcomes were dependency, motor function, depression and swallowing function. Subgroup analysis was performed, and publication bias was assessed using funnel plots. SUMMARY OF REVIEW: 58 studies and 6339 patients were included in the meta-analysis. Subgroup analysis revealed that combined therapy comprising both acupuncture and WM had a superior effect on improving dependency and swallowing function compared with standard WM therapy alone. Potential superiority of combined therapy comprising CM and WM in improving depression compared with standard WM therapy was also found. CONCLUSIONS: Our results indicate that the combined use of CM and WM could be more efficacious in stroke rehabilitation compared with the use of WM therapy alone. However, most studies were short in duration (2 to 4 weeks) and prone to different types of biases, which prevents making any conclusion regarding the long-term effects and raises concerns regarding true efficacy in context of high likelihood of Hawthorn bias. So, more randomised controlled trials with more rigorous design and longer duration of treatment and follow-up need to be conducted to compare WM alone versus WM and CM combined. PROSPERO REGISTRATION NUMBER: CRD42020152050.

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): Safety analyses of a randomized clinical trial.

BACKGROUND AND AIM: To report the six-month safety analyses among patients enrolled in the "Physical Fitness Training in Subacute Stroke-PHYS-STROKE" trial and identify underlying risk factors associated with serious adverse events. METHODS: We performed a pre-specified safety analysis of a multicenter, randomized controlled, endpoint-blinded trial comprising 200 patients with moderate to severe subacute stroke (days 5-45 after stroke) that were randomly assigned (1:1) to receive either aerobic, bodyweight supported, treadmill-based training (n = 105), or relaxation sessions (n = 95, control group). Each intervention session lasted for 25 min, five times weekly for four weeks, in addition to standard rehabilitation therapy. Serious adverse events defined as cerebro- and cardiovascular events, readmission to hospital, and death were assessed during six months of follow-up. Incident rate ratios (IRR) were calculated, and Poisson regression analyses were conducted to identify risk factors for serious adverse events and to test the association with aerobic training. RESULTS: Six months after stroke, 50 serious adverse events occurred in the trial with a higher incidence rate (per 100 patient-months) in the training group compared to the relaxation group (6.31 vs. 3.22; IRR 1.70, 95% CI 0.96 to 3.12). The association of aerobic training with serious adverse events incidence rates were modified by diabetes mellitus (IRR for interaction: 7.10, 95% CI 1.56 to 51.24) and by atrial fibrillation (IRR for interaction: 4.37, 95% CI 0.97 to 31.81). CONCLUSIONS: Safety analysis of the PHYS-STROKE trial found a higher rate of serious adverse events in patients randomized to aerobic training compared to control within six months after stroke. Exploratory analyses found an association between serious adverse events occurrence in the aerobic training group with pre-existing diabetes mellitus and atrial fibrillation which should be further investigated in future trials. DATA ACCESS STATEMENT: The raw data and analyses scripts are provided by the authors on a secure online repository for reproduction of reported findings.