Dataset Information

Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial.

ABSTRACT:

Background

Poststroke aphasia (PSA) is a disabling condition that decreases the quality of life, and the duration of the disease harms the quality of life of PSA patients. Acupuncture has been widely employed for PSA. There is some evidence for the immediate treatment efficacy of acupuncture for PSA; however, long-term results after acupuncture may be poorer.

Methods

This is a multicentre, randomized, blinded, nonacupoint (NA) acupuncture controlled, multimodal neuroimaging clinical trial. A total of 48 subjects with subacute PSA will be randomly assigned to an acupoint group or an NA control group. The acupoint group will receive acupuncture with normal needling at DU20, EX-HN1, HT5, GB39, EX-HN12, EX-HN13, and CV23. The NA control group will receive acupuncture in locations not corresponding to acupuncture points as sham acupoints. Both groups will receive identical speech and language therapy thrice a week for four weeks. The primary outcome will be the change in the aphasia quotient (AQ) score measured by the Western Aphasia Battery (WAB) test during the 12th week after randomization. Participants will be blindly assessed at prerandomization (baseline) and 4?weeks, 12?weeks, and 24?weeks after randomization. The secondary outcomes include the Boston Diagnostic Aphasia Examination (BDAE) score, the Disease Prognosis Scale score for ischaemic stroke, etc. Magnetic resonance imaging (MRI) and electroencephalogram (EEG) will also be performed at 4-time intervals as secondary outcomes. All scores and image evaluations will be taken at the same point as the linguistic evaluation. The multilevel evaluation technique will be used to assess the long-term efficacy of acupuncture therapy. MRI scans and EEG will be used to assess acupuncture-related neuroplasticity changes. Discussion. The results from our trial will help to supply evidence for the long-term acupuncture effects for PSA over a long follow-up period. It will provide valuable information for future studies in the field of PSA treatment. The trial was registered at the Chinese Clinical Trial Registry on 16 March 2020 (ChiCTR2000030879).

SUBMITTER: Li X

PROVIDER: S-EPMC7895559 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial.

Li Xiaolin X Gao Ying Y Zhang Chi C Zhang Qingsu Q Xin Xiyan X Tan Zhongjian Z Zhang Binlong B Fan Ruiwen R Huang Xing X Xu Minjie M Shu Xin X Yan Heming H Li Changming C Kong Qiao Q Li Shuren S Chang Jingling J

Evidence-based complementary and alternative medicine : eCAM 20210212

<h4>Background</h4>Poststroke aphasia (PSA) is a disabling condition that decreases the quality of life, and the duration of the disease harms the quality of life of PSA patients. Acupuncture has been widely employed for PSA. There is some evidence for the immediate treatment efficacy of acupuncture for PSA; however, long-term results after acupuncture may be poorer.<h4>Methods</h4>This is a multicentre, randomized, blinded, nonacupoint (NA) acupuncture controlled, multimodal neuroimaging clinic ...[more]

PMID: 33628323

Similar Datasets

Project description:IntroductionPoststroke depression is a serious and common complication of stroke, especially the ischemic poststroke depression. Antidepressants are used in poststroke depression, and acupuncture may be an alternative approach. However, the efficacy and mechanism of acupuncture for poststroke depression has not been confirmed.Methods/designThis is a multicenter, central-randomized, single-blind, sham-controlled clinical trial. We will allocate 208 subjects aged between 40 and 80 years old, diagnosed with initial poststroke depression (PSD) within 6 months to 2 groups randomly in a ratio of 1:1. Patients in the experimental group will be treated with traditional acupuncture and placebo pills, whereas the others in the control group will be treated with sham-acupoints acupuncture and antidepressant (fluoxetine hydrochloride tablets). All will be given acupuncture and/or medication treatment for 12 weeks, and then received 12-week follow-up. Patients will be evaluated with the 17-item Hamilton Depression Scale and Se1f-rating Depression Scale for depression state, National Institute of Health Stroke Scale for neurological deficit, Modified Barthel Index for activities of daily living, Treatment Emergent Symptom Scale for side effects of treatments, diagnosis and evaluation criteria of traditional Chinese medicine for stroke (try out) for curative effects of stroke, and clinical global impression for synthesize effect before and the 2nd, 4th, 8th, and 12th week of treatment, 24th week of follow-up. Study on mechanisms of acupuncture will be revealed through the diversity of brain metabolites (choline-containing compounds [Cho], N-acetylaspartate [NAA], myoinositol, glutamine and glutamate complex, creatine [Cr], Cho/Cr, Cho/NAA, Cr/NAA) in bilateral dorsolateral prefrontal cortex and anterior cingulate cortex monitored by proton magnetic resonance spectroscopy, and serum monoamine neurotransmitters (5-hydroxytryptamine, norepinephrine, dopamine) and cytokines (brain-derived neurotrophic factor [BDNF], interleukin [IL]-4, IL-6, IL-10, IL-18, IL-1β, tumor necrosis factor alpha) before and the 12th week of treatment. Baseline characteristics of patients will be summarized by groups and compared with chi-square for categorical variables, and 2-sample t tests or Wilcoxon rank-sum test for the continuous variables. Primary and secondary outcomes according to the measurement times are applicable to univariate repetitive measurement deviation analysis or 2-sample t tests, or Wilcoxon rank-sum test.ConclusionThe present research is designed to investigate efficacy and mechanism of traditional acupuncture therapy on ischemic PSD, also to explore the correlation between cerebra metabolic and serologic factors, and ischemic PSD. With this research, we are looking forward to find out an appropriate alternative nondrug therapy for PSD people to alleviate the adverse effects and drug dependence caused by antidepressants.

Project description:BackgroundAphasia is a common symptom in stroke patients, presenting with the impairment of spontaneous speech, repetition, naming, auditory comprehension, reading, and writing function. Multiple rehabilitation methods have been suggested for the recovery of poststroke aphasia, including medication treatment, behavioral therapy, and stimulation approach. Acupuncture has been proven to have a beneficial effect on improving speech functions in repetition, oral speech, reading, comprehension, and writing ability. Neuroimaging technology provides a visualized way to explore cerebral neural activity, which helps reveal the therapeutic effect of acupuncture therapy. In this systematic review, we aim to reveal and summarize the neuroimaging mechanism of acupuncture therapy on poststroke aphasia to provide the foundation for further study.MethodsSeven electronic databases were searched including PubMed, Web of Science, Embase, Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, the Wanfang databases, and the Chinese Scientific Journal Database. After screening the studies according to the inclusion and exclusion criteria, we summarized the neuroimaging mechanism of acupuncture on poststroke aphasia, as well as the utilization of acupuncture therapy and the methodological characteristics.ResultAfter searching, 885 articles were retrieved. After removing the literature studies, animal studies, and case reports, 16 studies were included in the final analysis. For the acupuncture type, 10 studies used manual acupuncture and 5 studies used electroacupuncture, while body acupuncture (10 studies), scalp acupuncture (7 studies), and tongue acupuncture (8 studies) were applied for poststroke aphasia patients. Based on blood oxygen level-dependent (BOLD) and diffusion tensor imaging (DTI) technologies, 4 neuroimaging analysis methods were used including amplitude of low-frequency fluctuation (ALFF), regional homogeneity (ReHo), seed-based analysis, and independent component analysis (ICA). Two studies reported the instant acupuncture effect, and 14 studies reported the constant acupuncture's effect on poststroke aphasia patients. 5 studies analyzed the correlation between the neuroimaging outcomes and the clinical language scales.ConclusionIn this systematic review, we found that the mechanism of acupuncture's effect might be associated with the activation and functional connectivity of language-related brain areas, such as brain areas around Broca's area and Wernicke's area in the left inferior temporal gyrus, supramarginal gyrus, middle frontal gyrus, and inferior frontal gyrus. However, these studies were still in the preliminary stage. Multicenter randomized controlled trials (RCT) with large sample sizes were needed to verify current evidence, as well as to explore deeply the neuroimaging mechanisms of acupuncture's effects.

Project description:IntroductionAphasia is a common language disorder acquired after stroke that reduces the quality of life of affected patients. The impairment is frequently accompanied by a deficit in cognitive functions. The state-of-the-art therapy is speech and language therapy but recent findings highlight positive effects of high-frequency therapy. Telerehabilitation has the potential to enable high-frequency therapy for patients at home. This study investigates the effects of high-frequency telerehabilitation speech and language therapy (teleSLT) on language functions in outpatients with aphasia compared with telerehabilitative cognitive training. We hypothesise that patients training with high-frequency teleSLT will show higher improvement in language functions and quality of life compared with patients with high-frequency tele-rehabilitative cognitive training (teleCT).Methods and analysisThis study is a randomised controlled, evaluator-blinded multicentre superiority trial comparing the outcomes following either high-frequency teleSLT or teleCT. A total of 100 outpatients with aphasia will be recruited and assigned in a 1:1 ratio stratified by trial site and severity of impairment to one of two parallel groups. Both groups will train over a period of 4 weeks for 2 hours per day. Patients in the experimental condition will devote 80% of their training time to teleSLT and the remaining 20% (24 min/day) to teleCT, vice versa for patients in the control condition. The primary outcome measure is the understandability of verbal communication on the Amsterdam Nijmegen Everyday Language Test and secondary outcome measures are intelligibility of the verbal communication, impairment of receptive and expressive language functions, confrontation naming. Other outcomes measures are quality of life and acceptance (usability and subjective experience) of the teleSLT system.Ethics and disseminationThis study is approved by the Ethics Committee Bern (ID 2016-01577). Results will be submitted to a peer-reviewed journal.Trial registration numberNCT03228264.

Project description:ObjectiveTo determine the safety and efficacy of aerobic exercise on activities of daily living in the subacute phase after stroke.DesignMulticentre, randomised controlled, endpoint blinded trial.SettingSeven inpatient rehabilitation sites in Germany (2013-17).Participants200 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.InterventionParticipants 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 measuresThe 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.ResultsCompared 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).ConclusionsAmong 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 registrationClinicalTrials.gov NCT01953549.

Project description:BackgroundRecovery of walking ability is an important goal for patients poststroke, and a basic level of mobility is critical for an early discharge home. Caregiver-mediated exercises could be a resource-efficient strategy to augment exercise therapy and improve mobility in the first months poststroke. A combination of telerehabilitation and face-to-face support, blended care, may empower patient-caregiver dyads and smoothen the transition from professional support to self-management. The Armed4Stroke study aims to investigate the effects of a caregiver-mediated exercise program using a blended care approach in addition to usual care, on recovery of mobility in the first 6 months poststroke.MethodsA multicentre, observer-blinded randomized clinical trial in which 74 patient-caregiver dyads will be enrolled in the first 3 months poststroke. Dyads are randomly allocated to a caregiver-mediated exercises intervention or to a control group. The primary endpoint is the self-reported mobility domain of the Stroke Impact Scale. Secondary endpoints include care transition preparedness and psychological functioning of dyads, length of inpatient stay, gait-related measures and extended ADL of patients, and caregiver burden. Outcomes are assessed at enrolment, end of treatment and 6 months follow-up.ResultsDuring 8 weeks, caregivers are trained to become an exercise coach using a blended care approach. Dyads will receive a tailor-made, progressive training program containing task-specific exercises focusing on gait, balance, physical activity and outdoor activities. Dyads are asked to perform the training program a minimum of 5 times a week for 30 min per session, supported by a web-based telerehabilitation system with instruction videos and a messaging environment to communicate with their physiotherapist.ConclusionsWe hypothesize that the Armed4Stroke program will increase self-reported mobility and independence in ADL, facilitating an early discharge poststroke. In addition, we hypothesize that active involvement of caregivers and providing support using blended care, will improve the care transition when professional support tapers off. Therefore, the Armed4Stroke program may complement early supported discharge services.Trial registrationNetherlands Trial Register, NL7422 . Registered 11 December 2018.

Project description:Background and objectivesChronic poststroke language impairment is typically worse in older individuals or those with large stroke lesions. However, there is unexplained variance that likely depends on intact tissue beyond the lesion. Brain age is an emerging concept, which is partially independent from chronologic age. Advanced brain age is associated with cognitive decline in healthy older adults; therefore, we aimed to investigate the relationship with stroke aphasia. We hypothesized that advanced brain age is a significant factor associated with chronic poststroke language impairments, above and beyond chronologic age, and lesion characteristics.MethodsThis cohort study retrospectively evaluated participants from the Predicting Outcomes of Language Rehabilitation in Aphasia clinical trial (NCT03416738), recruited through local advertisement in South Carolina (US). Primary inclusion criteria were left hemisphere stroke and chronic aphasia (≥12 months after stroke). Participants completed baseline behavioral testing including the Western Aphasia Battery-Revised (WAB-R), Philadelphia Naming Test (PNT), Pyramids and Palm Trees Test (PPTT), and Wechsler Adult Intelligence Scale Matrices subtest, before completing 6 weeks of language therapy. The PNT was repeated 1 month after therapy. We leveraged modern neuroimaging techniques to estimate brain age and computed a proportional difference between chronologic age and estimated brain age. Multiple linear regression models were used to evaluate the relationship between proportional brain age difference (PBAD) and behavior.ResultsParticipants (N = 93, 58 males and 35 females, average age = 61 years) had estimated brain ages ranging from 14 years younger to 23 years older than chronologic age. Advanced brain age predicted performance on semantic tasks (PPTT) and language tasks (WAB-R). For participants with advanced brain aging (n = 47), treatment gains (improvement on the PNT) were independently predicted by PBAD (T = -2.0474, p = 0.0468, 9% of variance explained).DiscussionThrough the application of modern neuroimaging techniques, advanced brain aging was associated with aphasia severity and performance on semantic tasks. Notably, therapy outcome scores were also associated with PBAD, albeit only among participants with advanced brain aging. These findings corroborate the importance of brain age as a determinant of poststroke recovery and underscore the importance of personalized health factors in determining recovery trajectories, which should be considered during the planning or implementation of therapeutic interventions.

Dataset Information

Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial.

Background

Methods

Publications

Evaluating the Long-Term Efficacy of Acupuncture Therapy for Subacute Poststroke Aphasia: Study Protocol for a Randomized, Blinded, Controlled, Multicentre Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets