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.

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).

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.

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.

Acupuncture for patients recovering from lacunar infarction: A protocol for systematic review and meta-analysis.

BACKGROUND: Lacunar infarction (LI) is the mild type in the classification of ischemic stroke, mostly occurs in the middle-aged and elderly, with mild hemiplegia and partial sensory disorder as the main manifestations. In the treatment of LI, acupuncture is often regarded as dominant therapy in the convalescence period. However, acupuncture for treatment of LI in the recovery period lacks high-quality reports and evidence-based medical evidence. Thus, we aim to evaluate the curative effect and safety of acupuncture for LI objectively. METHODS: Pubmed, Cochrane Library, Web of Science, EBSCO, Springer, China National Knowledge Infrastructure, Chinese Scientific and Technical Journals Database (VIP), Wan-fang Database, Chinese Biomedical Literature Database, Chinese Science Citation Database, and other electronic databases will be retrieved from the inception to May, 2021. Randomized controlled trials related to this subject will be searched. The inclusion criteria are established and a detailed literature search strategy is designed through discussion. Article retrieval, screening, excluding repetitive studies, assessment of quality, and data processing will be conducted by 2 reviewers independently using EndNote (X9) and Review Manager (5.3.5). The outcome measures include primary outcome measures (total effective rate, National Institute of Health Stroke Scale score, and Fugl-Meyer Assessment score), secondary outcome measures (blood pressure, plasma glucose, and blood lipid), and safety outcome measures. We will perform a meta-analysis, descriptive analysis, and subgroup analysis based on data conditions. RESULTS: The study of total effective rate, National Institute of Health Stroke Scale score, Fugl-Meyer Assessment score, blood pressure, plasma glucose, blood lipid, and adverse effects will provide evidenced outcome for high-quality synthesis and descriptive analysis. CONCLUSION: This systematic review will kindly provide evidence of whether acupuncture is an effective and safe intervention for LI in the recovery period. INPLASY REGISTRATION NUMBER: INPLASY202150060 (DOI:10.37766/inplasy2021.5.0060).

Analysis of Clinical Efficacy of Traditional Chinese Medicine in Recovery Stage of Stroke: A Systematic Review and Meta-Analysis.

BACKGROUND: We provide an updated meta-analysis with detailed information on a combination of TCM and routine treatment. METHODS: Retrieve appropriate articles with no language restrictions on keywords until 8 July 2019 in an electronic database. All trajectories are screened according to certain criteria. The quality of certified research was also evaluated. We made a detailed record of the results of the measurement. Meta-analysis was carried out by using the Revman 5.3 software. RESULTS: Sixty-seven RCTs were included, and 6594 subjects were analyzed. Compared with routine treatment, the total effective rate (TER) of TCM combined with routine treatment was improved, and the recovery of stroke was also significantly accelerated. Regulation of blood lipids by notably shrinking the contents of TC, TG, and LDL and enhancing the levels of HDL. The levels of serum hs-CRP, WHV, and WLV decreased significantly, indicating that the expression of thrombomodulin was decreased after the comprehensive treatment of traditional Chinese medicines (TCMs). The combination of TCM treatment could enhance the protection of neural function by decreasing the NIHSS scoring while increasing the BI scoring. Paeoniae Radix Rubra, Angeticae Sinensis Radix, etc., can effectively improve the clinical symptoms of stroke convalescent patients and promote the recovery of neurological function. ACU of Baihui, Renzhong, etc., can improve the clinical rehabilitation effect of patients. However, our findings must be handled with care because of the small sample size and low quality of clinic trials cited. Other rigorous and large-scale RCTs are in need to confirm these results. CONCLUSION: A combination of TCM and routine treatment in the treatment of stroke could improve TER, and it is beneficial to the rehabilitation of patients in the recovery period of apoplexy. These effects can be mediated by a combination of several mechanisms. Nevertheless, due to the limitations of this study, these results should be handled with caution.

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.

Physical Fitness Training in Patients with Subacute Stroke (PHYS-STROKE): multicentre, randomised controlled, endpoint blinded trial.

OBJECTIVE: To determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke. DESIGN: Multicentre, randomised controlled, endpoint blinded trial. SETTING: Seven inpatient rehabilitation sites in Germany (2013-17). PARTICIPANTS: 200 adults with subacute stroke (days 5-45 after stroke) with a median National Institutes of Health stroke scale (NIHSS, range 0-42 points, higher values indicating more severe strokes) score of 8 (interquartile range 5-12) were randomly assigned (1:1) to aerobic physical fitness training (n=105) or relaxation sessions (n=95, control group) in addition to standard care. INTERVENTION: Participants received either aerobic, bodyweight supported, treadmill based physical fitness training or relaxation sessions, each for 25 minutes, five times weekly for four weeks, in addition to standard rehabilitation therapy. Investigators and endpoint assessors were masked to treatment assignment. MAIN OUTCOME MEASURES: The primary outcomes were change in maximal walking speed (m/s) in the 10 m walking test and change in Barthel index scores (range 0-100 points, higher scores indicating less disability) three months after stroke compared with baseline. Safety outcomes were recurrent cardiovascular events, including stroke, hospital readmissions, and death within three months after stroke. Efficacy was tested with analysis of covariance for each primary outcome in the full analysis set. Multiple imputation was used to account for missing values. RESULTS: Compared with relaxation, aerobic physical fitness training did not result in a significantly higher mean change in maximal walking speed (adjusted treatment effect 0.1 m/s (95% confidence interval 0.0 to 0.2 m/s), P=0.23) or mean change in Barthel index score (0 (-5 to 5), P=0.99) at three months after stroke. A higher rate of serious adverse events was observed in the aerobic group compared with relaxation group (incidence rate ratio 1.81, 95% confidence interval 0.97 to 3.36). CONCLUSIONS: Among moderately to severely affected adults with subacute stroke, aerobic bodyweight supported, treadmill based physical fitness training was not superior to relaxation sessions for maximal walking speed and Barthel index score but did suggest higher rates of adverse events. These results do not appear to support the use of aerobic bodyweight supported fitness training in people with subacute stroke to improve activities of daily living or maximal walking speed and should be considered in future guidelines. TRIAL REGISTRATION: ClinicalTrials.gov NCT01953549.

A clinical study to assess the influence of acupuncture at "Wang's Jiaji" acupoints on limb spasticity in patients in convalescent stage of ischemic stroke: study protocol for a randomized controlled trial.

BACKGROUND: Stroke is characterized by high morbidity, high mortality, and high disability. Spasticity, one of the most common complications after stroke, may reduce the potential success of rehabilitation and has a detrimental effect on stroke patients' daily function and quality of life. Moreover, the long-term management of spasticity is a financial burden to patients and increases societal costs. The current treatments, mainly including physical therapy, oral drugs, drug injection therapy, and surgical interventions, have been used to reduce spasticity. However, every conventional approach has its limitations. Acupuncture at the "Wang's Jiaji" acupoints, based on the experience of the famous old doctor of traditional Chinese medicine (TCM) Le Ting Wang in treating post-stroke limb spasm, has been widely practiced in our department. This intervention has effectively avoided the controversy around acupuncture at local acupoints on the limbs, and is easy to apply without side effects. Our previous studies had found that acupuncture at the "Wang's Jiaji-points" can reduce the occurrence and severity of spasticity occurring after stroke in the early stage (the first 21 days). In this study, we chose patients in the convalescent stage, 1-6 months after stroke, so as to study the efficacy and the specific intervention time of "Wang's jiaji" in the convalescent stage after stroke. METHODS: This is a randomized, controlled, and single-blind study. Patients in the convalescent stage within 1-6 months of ischemic stroke will be selected as subjects. A total of 100 subjects will be randomly assigned to two groups. The acupuncture group will be given acupuncture treatment five times a week; the medicine group will be given 10mg baclofen three times a day. These two groups will continue to receive current usual care for the prevention and treatment of cerebrovascular diseases, but drugs that affect muscle tone will not be allowed. The treatment will last for 2 weeks. The primary outcome measurement is the simplified Fugl-Meyer Assessment. The secondary outcome measurements are the Modified Ashworth Scale, Modified Barthel Scale, and the H-reflex, F response, and H/M ratios of electromyography. All outcome measurements are assessed at baseline, 2 weeks, 4 weeks, and 12 weeks after first treatment except the electromyography, which is assessed at baseline and 2 weeks after first acupuncture. DISCUSSION: This trial aims to evaluate the effects and the specific intervention time of "Wang's Jiaji" acupoints on spasticity after stroke. TRIAL REGISTRATION: ISRCTN registry, ISRCTN31511176 . Registered on 29 August 2017. Version number of protocol 2016-2-1161 Version date of protocol: 2016-1.

The Effectiveness of Fluidotherapy in Poststroke Complex Regional Pain Syndrome: A Randomized Controlled Study.

OBJECTIVE: To evaluate whether combining fluidotherapy to conventional rehabilitation program provides additional improvements on pain severity, upper extremity functions, and edema volume in patients with poststroke complex regional pain syndrome (CRPS). DESIGN: Randomized controlled trial. SETTING: Training and research hospital. PARTICIPANTS: Thirty hemiplegic patients with subacute stage CRPS type-1 of the upper extremity. INTERVENTIONS: The patients randomly divided into 2 groups. Both groups received a 3 week conventional rehabilitation program (5 days/week, 2-4 hours/day). Experimental group received 15 sessions additional fluidotherapy application to the affected upper extremity (40 °C, 20 minutes in continuous mode, 5 sessions/week). MAIN OUTCOME MEASURES: We evaluated the distal upper arm edema with a volumeter. Other used clinical assessment scales were Brunnstrom recovery stages of the arm and hand for motor recovery, motor items of the functional independence measure for functional status, visual analog scale for pain severity, and the painDETECT questionnaire for presence and the severity of neuropathic pain. RESULTS: The mean age of the participants was 64.3 ± 11.66 (28-84). At the post-treatment evaluation, significant improvements were revealed regarding to the edema volume, pain visual analog scale, painDETECT and functional independence measure scores, and the Brunnstrom stages of upper extremity and hand in both groups (P < .05). But among the parameters mentioned above, only the decrease in edema volume and the painDETECT scores were greater in fluidotherapy group than the control group (P < .05). CONCLUSIONS: Addition of the fluidotherapy to the conventional rehabilitation program provides better improvements on neuropathic pain and edema volume in subacute stage poststroke CRPS.

Effectiveness and safety of electroacupuncture for poststroke patients with shoulder pain: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial.

BACKGROUND: Practitioners of complementary and alternative medicine have suggested that acupuncture could alleviate poststroke shoulder pain, based on the clinical evidence. This study protocol is aimed at showing the effectiveness and safety of electroacupuncture therapy for stroke survivors with shoulder pain. METHODS: After assessing their eligibility, 60 stroke survivors with shoulder pain will be enrolled from two traditional Korean medicine hospitals and randomly divided into either the verum or the sham electroacupuncture (EA) group with a 1:1 ratio. The participants will receive 9 sessions of EA procedures for 3 weeks. The verum EA consists of needling on 6 unilateral acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) with electronic stimulation. A non-penetrating Park sham device and fake electronic stimulation will be used in the sham group on the same acupoints. Patients and outcome assessors will be blinded throughout the entire study. A visual analog scale will be used primarily for the evaluation, and pain rating scale, Fugl-Meyer assessment for upper extremity, modified Ashworth scale, manual muscle test, passive range of motion test, Korean version of a modified Barthel index, and Korean version of the Beck depression inventory will be also be measured. A blinding index will be assessed. For safety, adverse events will be recorded. Data will be statistically analyzed by two-sample t-test or Wilcoxon rank sum test for efficacy and a chi-squared test or Fisher's exact test for safety, at 5% of significance level. DISCUSSION: We expect this double-center, randomized, sham-controlled, patient- and assessor-blinded parallel trial to explore the effectiveness and safety of EA therapy, compared with sham EA, for poststroke shoulder pain. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03086863.

Effect of Combined Treatment with MLC601 (NeuroAiDTM) and Rehabilitation on Post-Stroke Recovery: The CHIMES and CHIMES-E Studies.

BACKGROUND AND PURPOSE: MLC601 has been shown in preclinical studies to enhance neurorestorative mechanisms after stroke. The aim of this post hoc analysis was to assess whether combining MLC601 and rehabilitation has an effect on improving functional outcomes after stroke. METHODS: Data from the CHInese Medicine NeuroAiD Efficacy on Stroke (CHIMES) and CHIMES-Extension (CHIMES-E) studies were analyzed. CHIMES-E was a 24-month follow-up study of subjects included in CHIMES, a multi-centre, double-blind placebo-controlled trial which randomized subjects with acute ischemic stroke, to either MLC601 or placebo for 3 months in addition to standard stroke treatment and rehabilitation. Subjects were stratified according to whether they received or did not receive persistent rehabilitation up to month (M)3 (non- randomized allocation) and by treatment group. The modified Rankin Scale (mRS) and Barthel Index were assessed at month (M) 3, M6, M12, M18, and M24. RESULTS: Of 880 subjects in CHIMES-E, data on rehabilitation at M3 were available in 807 (91.7%, mean age 61.8 ± 11.3 years, 36% female). After adjusting for prognostic factors of poor outcome (age, sex, pre-stroke mRS, baseline National Institute of Health Stroke Scale, and stroke onset-to-study-treatment time), subjects who received persistent rehabilitation showed consistently higher treatment effect in favor of MLC601 for all time points on mRS 0-1 dichotomy analysis (ORs 1.85 at M3, 2.18 at M6, 2.42 at M12, 1.94 at M18, 1.87 at M24), mRS ordinal analysis (ORs 1.37 at M3, 1.40 at M6, 1.53 at M12, 1.50 at M18, 1.38 at M24), and BI ≥95 dichotomy analysis (ORs 1.39 at M3, 1.95 at M6, 1.56 at M12, 1.56 at M18, 1.46 at M24) compared to those who did not receive persistent rehabilitation. CONCLUSIONS: More subjects on MLC601 improved to functional independence compared to placebo among subjects receiving persistent rehabilitation up to M3. The larger treatment effect of MLC601 was sustained over 2 years which supports the hypothesis that MLC601 combined with rehabilitation might have beneficial and sustained effects on neuro-repair processes after stroke. There is a need for more data on the effect of combining rehabilitation programs with stroke recovery treatments.

The effect and biomechanical mechanisms of intradermal needle for post-stroke hemiplegia recovery: Study protocol for a randomized controlled pilot trial.

The incidence of stroke has increased significantly in recent years. Post-stroke hemiplegia is a common stroke complication with long-term negative consequences. Several studies have suggested that acupuncture could be an effective intervention for the rehabilitation of post-stroke hemiplegia. Intradermal needling is a kind of acupuncture which is widely used in clinical settings. This study attempts to investigate the biomechanical effects of intradermal needle for post-stroke hemiplegia recovery.This proposed study is a single-centered, prospective, single-blinded (patient-assessor-blinded), randomized clinical pilot trial involving 40 patients with post-stroke hemiplegia. Patients will be randomized to an experimental group or control group in a 1:1 ratio. All of them will receive conventional rehabilitation therapies. Patients in the experimental group will be treated with intradermal needle, whereas patients in the control group will receive sham intradermal needle. The primary outcome measures will be biomechanically validated from the parameters of RSSCAN gait system: plantar pressure distribution, step length, and stride. The scores of clinical scales such as National Institutes of Health Stroke Scale, Fugl-Meyer Assessment, Berg Balance Scale, Barthel Index, and Stroke-specific Quality of Life Scale will be assessed as secondary outcome measures. All assessments will be conducted at baseline, 4 weeks after intervention and at the end of 3 months' follow-up.The purpose of this study is to explore the potential effect and biomechanical mechanisms of intradermal needle for post-stroke hemiplegia recovery, as well as to provide a basis for future larger clinical studies.

Arm rehabilitation in post stroke subjects: A randomized controlled trial on the efficacy of myoelectrically driven FES applied in a task-oriented approach.

PURPOSE: Motor recovery of persons after stroke may be enhanced by a novel approach where residual muscle activity is facilitated by patient-controlled electrical muscle activation. Myoelectric activity from hemiparetic muscles is then used for continuous control of functional electrical stimulation (MeCFES) of same or synergic muscles to promote restoration of movements during task-oriented therapy (TOT). Use of MeCFES during TOT may help to obtain a larger functional and neurological recovery than otherwise possible. STUDY DESIGN: Multicenter randomized controlled trial. METHODS: Eighty two acute and chronic stroke victims were recruited through the collaborating facilities and after signing an informed consent were randomized to receive either the experimental (MeCFES assisted TOT (M-TOT) or conventional rehabilitation care including TOT (C-TOT). Both groups received 45 minutes of rehabilitation over 25 sessions. Outcomes were Action Research Arm Test (ARAT), Upper Extremity Fugl-Meyer Assessment (FMA-UE) scores and Disability of the Arm Shoulder and Hand questionnaire. RESULTS: Sixty eight subjects completed the protocol (Mean age 66.2, range 36.5-88.7, onset months 12.7, range 0.8-19.1) of which 45 were seen at follow up 5 weeks later. There were significant improvements in both groups on ARAT (median improvement: MeCFES TOT group 3.0; C-TOT group 2.0) and FMA-UE (median improvement: M-TOT 4.5; C-TOT 3.5). Considering subacute subjects (time since stroke < 6 months), there was a trend for a larger proportion of improved patients in the M-TOT group following rehabilitation (57.9%) than in the C-TOT group (33.2%) (difference in proportion improved 24.7%; 95% CI -4.0; 48.6), though the study did not meet the planned sample size. CONCLUSION: This is the first large multicentre RCT to compare MeCFES assisted TOT with conventional care TOT for the upper extremity. No adverse events or negative outcomes were encountered, thus we conclude that MeCFES can be a safe adjunct to rehabilitation that could promote recovery of upper limb function in persons after stroke, particularly when applied in the subacute phase.

Acupuncture treatment on the motor area of the scalp for motor dysfunction in patients with ischemic stroke: study protocol for a randomized controlled trial.

BACKGROUND: Scalp acupuncture has shown a remarkable treatment efficacy on motor dysfunction in patients with stroke in China, especially the motor area of Jiao's scalp acupuncture, which is the most widely used treatment. However, previous studies have summarized that the clinical curative effect of acupuncture treatment for stroke remains uncertain. Meanwhile, no randomized controlled trials on Jiao's scalp acupuncture have been performed. The aim of this study is to evaluate the efficacy and safety of Jiao's scalp acupuncture for motor dysfunction in ischemic stroke. METHODS/DESIGN: This is an assessor- and analyst-blinded, randomized controlled trial. One hundred and eight stroke patients with motor dysfunction meeting the inclusion criteria will be allocated by a 1:1 ratio into either an acupuncture treatment group or a control group. Stroke patients in the control group will receive conventional rehabilitation treatment, whereas a combination of Jiao's scalp acupuncture and conventional rehabilitation treatment will be applied to the acupuncture group. Forty treatment sessions will be performed over an 8-week period. The Fugl-Meyer Assessment scale will be assessed as the primary outcome measure. The Modified Barthel Index, the Stroke-Specific Quality of Life, and the Stroke Syndrome of Traditional Chinese Medicine scales will be selected as secondary outcome measurements. All assessments will be conducted at baseline, week 4 (treatment 20), week 8 (treatment 40), week 12 (follow-up), and week 16 (follow-up). DISCUSSION: This is the first trial evaluating the efficacy and safety of Jiao's scalp acupuncture for motor dysfunction in ischemic stroke. The results of this trial are expected to provide relevant evidence demonstrating that Jiao's scalp acupuncture can be used as an effective rehabilitation treatment method for improving motor dysfunction in ischemic stroke. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02871453 . Registered on 17 July 2016.

Prognostic Factors and Pattern of Long-Term Recovery with MLC601 (NeuroAiD™) in the Chinese Medicine NeuroAiD Efficacy on Stroke Recovery - Extension Study.

BACKGROUND: The Chinese Medicine NeuroAiD Efficacy on Stroke recovery - Extension (CHIMES-E) study is among the few acute stroke trials with long-term outcome data. We aimed to evaluate the recovery pattern and the influence of prognostic factors on treatment effect of MLC601 over 2 years. METHODS: The CHIMES-E study evaluated the 2 years outcome of subjects aged ≥18 years with acute ischemic stroke, National Institutes of Health Stroke Scale (NIHSS) score 6-14, pre-stroke modified Rankin Scale (mRS) score ≤1 included in a multicenter, randomized, double-blind, placebo-controlled trial of MLC601 for 3 months. Standard stroke care and rehabilitation were allowed during follow-up with mRS score being assessed in-person at month (M) 3 and by telephone at M1, M6, M12, M18 and M24. RESULTS: Data from 880 subjects were analyzed. There was no difference in baseline characteristics between treatment groups. The proportion of subjects with mRS score 0-1 increased over time in favor of MLC601 most notably from M3 to M6, thereafter remaining stable up to M24, while the proportion deteriorating to mRS score ≥2 remained low at all time points. Older age (p < 0.01), female sex (p = 0.06), higher baseline NIHSS score (p < 0.01) and longer onset to treatment time (OTT; p < 0.01) were found to be predictors of poorer outcome at M3. Greater treatment effect, with more subjects improving on MLC601 than placebo, was seen among subjects with 2 or more prognostic factors (OR 1.65 at M3, 1.78 at M6, 1.90 at M12, 1.65 at M18, 1.39 at M24), especially in subjects with more severe stroke or longer OTT. CONCLUSIONS: The sustained benefits of MLC601 over 2 years were due to more subjects improving to functional independence at M6 and beyond compared to placebo. Selection of subjects with poorer prognosis, particularly those with more severe NIHSS score and longer OTT delay, as well as a long follow-up period, may improve the power of future trials investigating the treatment effect of neuroprotective or neurorestorative therapies.