Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial
Qian-qian Sun1, Dan-dan Xie2, Jing Tao1, Tie-bin Yan3, Hui-hua Liu3, Qiang Li2, Bing-tian Zhang2, Jun Xu4, Xiao-kuo He M.D. 2
1 School of Rehabilitation Medicine, Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian Province, China
2 Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine), Shiyan, Hubei Province, China
3 Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, Guangdong Province, China
4 Central Hospital of Wuhan, Wuhan, Hubei Province, China
|Date of Web Publication||2-Aug-2017|
Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine), Shiyan, Hubei Province
Source of Support: This study was supported by the Special Subject of Chinese Medicine Rehabilitation Research of State Administration of Traditional Chinese Medicine of China., Conflict of Interest: None
Background and objectives: Effect of conventional rehabilitation methods is still not satisfactory to patients with post-stroke hemiplegia. Studies have demonstrated that acupuncture can improve motor function in stroke patients. Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. We will observe the effects of acupuncture on neural plasticity in patients with post-stroke hemiplegia after acupuncture at Quchi and Zusanli.
Design: This is a prospective multicenter randomized parallel controlled trial.
Methods: The trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) at Quchi and Zusanli will be performed 15 minutes before conventional rehabilitation training (priority) or 15 minutes after conventional rehabilitation training (delay), once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Patients will undergo one follow-up assessment for 4 months.
Outcome measures: The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures.
Discussion: We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity.
Ethics and dissemination: The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. We will submit the trial's results for presentation at international scientific meetings and to peer-reviewed journals. The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted in January–February 2017. Patient recruitment began in March 2017. The follow-up will be completed in September 2018. Data analysis will be conducted in June 2019.
Trial registration: This trial was registered in the Chinese Clinical Trial Registry (registration No. ChiCTR-IPR-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical Trial Registry (www.acmctr.org/index.aspx; identifier: AMCTR-IPR-17000038) on February 7th, 2017.
Keywords: clinical trial; post-stroke hemiplegia; acupuncture; plasticity; functional recovery; simplified Fugl-Meyer motor function score; Brunnstrom stage classification; Barthel Index; multicenter randomized parallel controlled trial
|How to cite this article:|
Sun Qq, Xie Dd, Tao J, Yan Tb, Liu Hh, Li Q, Zhang Bt, Xu J, He Xk. Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial. Asia Pac J Clin Trials Nerv Syst Dis 2017;2:108-16
|How to cite this URL:|
Sun Qq, Xie Dd, Tao J, Yan Tb, Liu Hh, Li Q, Zhang Bt, Xu J, He Xk. Acupuncture regulation promotes functional recovery in patients with post-stroke hemiplegia: study protocol for a multicenter randomized parallel controlled trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2017 [cited 2017 Nov 22];2:108-16. Available from: http://www.actnjournal.com/text.asp?2017/2/3/108/211592
| Introduction|| |
Stroke is a common acute cerebrovascular disease, and two million new patients are reported in China every year (Liu and Huang, 2011). At present, the main treatment of stroke is ultra-early thrombolysis, which has a protective effect on neurons in the acute phase of cerebral infarction (Morris, 2008). However, most patients experience different degrees of sequelae after treatment, and thus stroke rehabilitation is necessary. Rehabilitation methods mainly include physical therapy (such as electrical stimulation), occupational therapy, orthosis therapy, and family education. These methods increase the excitability and “use-dependent plasticity” of the central nervous system, reorganize neural networks, and promote recovery of injury function by enhancing hemiplegic limb sensation and motion information input to the injured hemisphere. However, although these methods can reduce disability and substantially improve the daily life of patients, one study reported that 45% of patients who received post-stroke rehabilitation were not functionally independent 6 months after stroke (Hummel and Cohen, 2006).
Numerous studies have demonstrated that acupuncture can improve motor function in stroke patients (Yang et al., 2016; Cai et al., 2017; Cao et al., 2017; Ning et al., 2017). Acupuncture points Quchi (LI11) and Zusanli (ST36) are most commonly used in the treatment of post-stroke hemiplegia. Our previous studies suggested that acupuncture at these sites promoted proliferation and differentiation of endogenous neural stem cells in rat models of middle cerebral artery ischemia reperfusion (Chen et al., 2014). Additionally, acupuncture at Quchi and Zusanli enhanced expression of brain derived neurotrophic factor (BDNF) and glial cell-derived neurotrophic factor (GDNF) (Ye et al., 2014) and inhibited apoptosis (He et al., 2015), thereby promoting the recovery of motor function through the phosphoinositide 3-kinase/protein kinase B (PI3K/Akt) (He et al., 2015), Toll-like receptor 4/nuclear factor kappa B (TLR4/NF-κB) (He et al., 2016), extracellular regulated protein kinases (ERK) (He et al., 2015), and Notch signaling pathways (Chen et al., 2014). Other studies have reported that acupoint stimulation increases functional recovery in the hemiplegic limb by regulating the excitability of the cerebral cortex (Maioli et al., 2006; Zunhammer et al., 2012). Electroacupuncture at Zusanli and Sanyinjiao (SP6) increased the excitability of the hippocampal granular cell layer in rats, and elevated the magnitude of long-term potentiation by gating, thereby affecting brain plasticity (He et al., 2012).
Clinical neurophysiological methods will be used to determine whether acupuncture at Quchi and Zusanli can 1) regulate the excitability of the motor cortex corresponding to flexors and extensors of the bilateral upper and lower limbs, 2) induce competitive inhibition in the cerebral hemispheres, and 3) initiate changes in corticospinal long-term potentiation-like plasticity in stroke patients in different Brunnstrom stages. We will propose an optimal scheme for combined acupuncture and rehabilitation therapy.
| Methods/Design|| |
The multicenter randomized parallel controlled trial will be conducted in Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China.
A total of 210 patients with post-stroke hemiplegia will be randomized into an acupuncture priority group, acupuncture delay group, sham acupuncture priority group, and sham acupuncture delay group (n = 45). On the basis of basic treatment and conventional rehabilitation training, acupuncture (acupuncture priority group and acupuncture delay group) or sham acupuncture (sham acupuncture priority group and sham acupuncture delay group) will be performed at Quchi and Zusanli once a day for 30 minutes, 5 days per week, for 8 consecutive weeks. Acupuncture will be performed 15 minutes before conventional rehabilitation training in the acupuncture priority group and sham acupuncture priority group, and 15 minutes after conventional rehabilitation training in the acupuncture delay group and sham acupuncture delay group.
Investigators will assess the Brunnstrom stage classification, simplified Fugl-Meyer motor function score, and Barthel Index score in each participant every 2 weeks during the 8-week treatment. Follow-up assessments will be conducted once per month for 4 months. Electrophysiological examinations will be carried out before the first treatment and after the last treatment.
The primary outcome measure will be the difference in the simplified Fugl-Meyer motor function score between the post-treatment and pre-treatment assessments. Brunnstrom stage classification, Barthel Index score, and electrophysiological changes will serve as secondary outcome measures.
The study protocol follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidance for protocol reporting (Additional file 1).[Additional file 1]
We are recruiting patients with post-stroke hemiplegia who visit Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China.
Patients presenting with all of the following criteria will be considered for study inclusion.
- Accordance with the diagnostic criteria for stroke stated in Diagnostic Points of Various Cerebrovascular Diseases, formulated by the Fourth National Conference on Cerebrovascular Diseases of China (Chinese Neuroscience Association and Chinese Neurosurgery Society, 1996); confirmed by head computerized tomography or magnetic resonance imaging
- First occurrence of cerebral hemorrhage and cerebral infarction
- Course of disease ranging from 2 weeks to 1 year
- Limb movement dysfunction
- Brunnstrom stage classification (Brunnstrom, 1966) of the affected limb: stages 1–5
- Has not received regular Chinese medicine rehabilitation or modern rehabilitation
- Aged 30–80 years old, male or female
- Informed consent signed by the patient or their family
Patients with one or more of the following conditions will be excluded from this study.
- Unconsciousness, dementia combined with sensory aphasia or mental disorders, evaluated via the Mini-Mental State Examination (Folstein et al., 1983)
- Severe primary disease such as that of the heart, liver, kidney, and hematopoietic system
- Cognitive impairment, neuropsychiatric disorders, substance abuse or history of alcohol abuse
- Vital organ failure or critical illness
- Development of a disease such as cancer or a condition that has a greater effect on the quality of life of the patient compared with limb dysfunction after stroke
- Low likelihood of completing the basic course of treatment, expectation of poor compliance (i.e., unable to adhere to treatment) or difficultly with follow-up assessments
- Participation in other clinical trials.
Patients who meet one or more of the following criteria during the trial will be withdrawn from this study:
- Not treated as prescribed, cannot judge the effect
- Incomplete information affecting the efficacy or safety of participation
- Complications that affect efficacy and safety judgments or onset of diseases that affect the outcome
- The use of other therapies or drugs to increase the speed of recovery
The study design was completed in July 2013. Ethical approval was received in August 2013. Clinical registration was conducted from January–February 2017. Patient recruitment began in March 2017. The follow-up assessments will be completed in September 2018. Data analysis will be completed in June 2019.
Recruitment information will be posted on the bulletin boards in the relevant departments at Shiyan Taihe Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, and the Rehabilitation Hospital of Fujian University of Traditional Chinese Medicine, China. Outpatients and inpatients in the departments of neurology and rehabilitation will be recruited by physicians. Potential participants will be able to contact the project manager via telephone, email, and WeChat.
The baseline information is shown in [Table 1].
Randomization and blinding
Patients who meet the criteria will be accepted as study participants, and will be randomized into study groups by a professional statistician. The three hospitals will be coded. Random numbers will be produced using the random function UNIFORM(n) in SAS 9.0 (SAS Institute Inc., Cary, NC, USA) and sorted from smallest to largest. The rank number will be chosen as the basis for selecting the corresponding coding segments of each hospital. Similarly, four groups of random numbers will be produced. Each group in the study will contain 45 patients. Group assignment will be hidden in opaque envelopes. When a subject enters the trial, they will be assigned a number. The envelope with the corresponding number will be opened, and the subject will undergo the intervention indicated in the envelope. Patients and assessors will be blinded to group information.
On the basis of basic therapy (conventional medical treatment and health education), conventional rehabilitation training will be conducted for 30 minutes per day, 5 days per week, for 8 consecutive weeks in each group.
Acupuncture priority group: Patients will receive acupuncture 15 minutes before conventional rehabilitation training [Figure 1]. The acupuncture sites will be Quchi (LI11; in the elbow, specifically in the depression of the midpoint between Chize (LU5) and the lateral epicondyle of the humerus) and Zusanli (ST36; 3 cun (the width of the interphalangeal joint of the patient's thumb is considered as 1 cun) below Dubi (ST35), one finger width lateral from the anterior border of the tibia). Horizontal needling will be carried out until the desired sensation is produced, with a depth of 20 mm (Shi, 2008), without twirling, lifting, or thrusting, and then maintained for 30 minutes.
|Figure 1: Patterns of acupuncture and sham acupuncture.|
Note: (A, B) Sham acupuncture pattern; (C) true acupuncture. 1: Needle handle; 2: needle; 3: plastic ring; 4: plaster; 5: blunt tip of the needle; 6: sharp tip of the needle; 7: cutis.
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Acupuncture delay group: Patients will receive acupuncture 15 minutes after conventional rehabilitation training every day. The acupuncture protocol will be the same as in the acupuncture priority group.
Sham acupuncture priority group: Patients will receive sham acupuncture 15 minutes before conventional rehabilitation training every day. The needle tip used for sham acupuncture is flat, so it cannot pierce the skin [Figure 1]. Otherwise, the acupuncture protocol will be the same as in the acupuncture priority group.
Sham acupuncture delay group: Patients will receive sham acupuncture 15 minutes after conventional rehabilitation training. The acupuncture protocol will be the same as in the sham acupuncture priority group.
Evaluation of efficacy
During the 8-week treatment period, motor function in the hemiplegic limb will be examined every 2 weeks (via the Brunnstrom stage classification, simplified Fugl-Meyer motor function score, and Barthel Index). Patients will undergo one follow-up assessment per month for 4 months. Electrophysiological testing will be performed before the first treatment and after the last treatment.
Primary outcome measure
The primary outcome measure will be the efficacy of the treatment after the 8-week period, stated as a percentage calculated by taking the difference between the final simplified Fugl-Meyer motor function score and the baseline score, and dividing this value by the baseline score.
The simplified Fugl-Meyer motor function score is commonly used to assess motor function in hemiplegic patients. The score is sensitive and reliable. This scale contains 50 items, and is interpreted as follows. Basic recovery: The motion score increased by 100%, and the patient exhibits normal motor function. Significant improvement: The motion score increased by 92–98%, and slight motor impairment is observed. Improvement: The motion score increased by 10–91%, and moderate to severe motor impairment is observed. No changes: The motion score increased by 0–9%, and severe motor impairment is present. Aggravation: Decreased motor scores and severe motor impairment are observed (Gao and Zhuo, 1994). Basic recovery, significant improvement, and improvement are considered to reflect efficacious treatment.
Secondary outcome measures
- The Barthel Index: The index was designed and formulated by Dorother Barthel and Floorence Mahney in 1965 (Mahoney and Barthel, 1965). The Barthel Index has been used to assess activities of daily living since the 1980's in China. The percentage produced by dividing (the Barthel Index at 8 weeks−the index at baseline) by the index at baseline is considered the basis for the evaluation of activities of daily living. The scores are interpreted as follows. Significant efficiency: Efficacy index increased by ≥ 20%. Effective: Efficacy index increased by 12–20%. Invalid: Efficacy index increased by 0–12%. Aggravation: Reduced efficacy index.
- Brunnstrom stage classification: This classification system is utilized to evaluate the functional recovery of a hemiplegic limb, and has grades from 1–6. A low grade represents poor limb function (Brunnstrom, 1966).
- Electrophysiological testing: Electrophysiological testing is conducted using a repetitive transcranial magnetic stimulation instrument (Yiruide Medical, Wuhan, China).
- Resting motor evoked potential threshold: We will stimulate the motor areas of the cerebral cortex corresponding to the bilateral flexor carpi radialis, extensor digitorum communis muscle, and gastrocnemius muscles, and regulate the output of stimulator. The resting motor threshold was defined as the lowest stimulation intensity required to evoke a motor evoked potential in the resting first dorsal interosseous > 50 μV in 5 out of 10 trials.
- Input-output curve (TMS-MEP): We will gradually increase the output of magnetic stimulator and record the amplitude of the motor evoked potential. An input-output curve will be drawn with the evoked potential amplitude on the Y-axis and the output of the magnetic stimulator on the X-axis. We will record the changes in the input-output curve before and after acupuncture at Quchi and Zusanli.
- Cortical resting period: A hand-muscle developer will be used to maximize isometric contractions of the hands of the participants. We will record the surface electromyographic activity of flexor and extensor muscles in both upper limbs. A magnetic stimulator will be employed to stimulate bilateral cortical motor areas. The cortical resting period will be defined as the time from surface electromyography activity interruption and reemergence.
- Paired inhibition and paired facilitation: The interval timing of two stimuli will be regulated using software. The first stimulus will be a conditioned stimulus with an input intensity that is 80% of the resting motor threshold. The second stimulus will be a testing stimulus with an input intensity that is 120% of the resting motor threshold. The stimulus intervals will be 3 and 15 ms, to produce paired inhibition and paired facilitation. The changes in paired inhibition and paired facilitation will be recorded before and after acupuncture.
- Motor evoked potential amplitude: We will use electromyography to record the N20 latency of the somatosensory evoked potential of the median nerve on the healthy and affected sides before and after acupuncture. Electrical stimulation of the median nerve and magnetic stimulation of the contralateral motor cortex interval will be controlled as N20+5 ms. A pair of electromagnetic stimuli will be presented with an interval of 10 seconds. After 200 pairs of consecutive stimuli, we will record the changes in the amplitude of motor evoked potentials via 120% of the resting motor threshold.
- Adverse events: We will record adverse events, including nausea, vomiting, convulsion, and pain, that occur during acupuncture.
The schedule of outcome measurement assessments is shown in [Table 2].
A trial flow chart is shown in [Figure 2].
|Figure 2: Flow chart of trial protocol.|
Note: Brunnstrom stage classification, simplified Fugl-Meyer motor function assessment, and Barthel Index will be carried out every two weeks during the eight weeks of treatment. Follow-up assessments will be conducted monthly for 4 months, and electrophysiological testing will be performed before the first treatment and after the last treatment.
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The inspector will conduct an audit every month at each rehabilitation center. In the early stage of the trial, the inspector will optimize research programs, standardize neurophysiological testing, conduct an ethical examination to ensure ethical standards are met, and complete personnel training in each center. During the trial, the inspector will focus on monitoring the test schedule, ensuring that informed consent is obtained, reviewing the case report forms, verifying the source data, assisting in the creating of reports regarding adverse events and serious adverse events, filing documents, and evaluating trial implementation. In the late stage of the trial, the inspector will compile multicenter data to submit to the evaluation center, guide the researchers in completing the necessary test documents according to the regulations, and explain the responsibilities to the researchers after the trial.
Sample size calculation: Using the methods of previous studies that evaluated the effect of acupuncture on hemiplegic limb function combined with modern rehabilitation therapy (Cai et al., 2017; Cao et al., 2017; Ning et al., 2017), we calculated a final effective sample size of n = 45 per group using the sample size estimation formula , indicating that a total of 180 participants are necessary. If we assume a patient loss rate of 15%, we will require 207 patients per group. Therefore, the sample size should be not less than 210 participants. We used α = 0.05 and β = 0.10 for these calculations.
Validity evaluation: Statistical analysis will be performed using SPSS 22.0 software (IBM, Armonk, NY, USA). Data will be expressed as mean ± standard deviation. We will conduct tests of normality and homogeneity for variance. Normally distributed data with homogeneity of variance will be evaluated using t-tests. Non-normally distributed data with heterogeneity of variance will be evaluated using a double total Z test. Ranked data will be analyzed using Ridit. A P value of < 0.05 will be considered statistically significant. If adverse reactions occur, these data will be included in the statistics. Invalid data and data from participants who withdrew from the study will be included in the efficacy analysis. Results will follow the intention-to-treat principle.
Case report forms will be completed by clinical researchers, who will ensure accurate, complete, and timely data entry and keep the original records. All the data regarding this trial will be presented to Shiyan Taihe Hospital for further analysis in combination with clinical data. After data entry, statisticians will further verify and check the integrity and accuracy of the data. Appropriate data will be published at Clinical Trial Management Public Platform (www.medresman.org) within 6 months after the completion of the trial.
Feasibility analysis of the present study
Acupuncture at Quchi and Zusanli in patients with post-stroke hemiplegia has been extensively used in clinical settings. There are no reports of side effects after acupuncture in a large number of clinical applications. Electrophysiological techniques have been carried out in various rehabilitation centers for clinical use. The research data from each test center will be comparable after the data are standardized. Each center has participated in provincial and ministerial clinical studies supported by the National Natural Science Foundation of China and the Science and Technology Project in 12th Five-Year Plan Period. The three rehabilitation centers belong to third-class first-grade hospitals, have strong scientific research programs, and are national hubs for rehabilitation and traditional Chinese medicine. The average number of inpatients being treated for stroke each day in these hospitals combined is close to 800, and inpatients undergo electrophysiological examination, electromyography, and transcranial magnetic stimulation.
The conditions of the clinical trial facilities will meet the standards for safe and effective clinical trials. All researchers will have the expertise, qualifications, and abilities to undertake the clinical trial and be trained in the protocols. Prior to the trial, researchers and the sponsor will reach an agreement regarding the test scheme, monitoring, auditing, standard operating procedures, and the division of responsibilities. The data in the case report form will come from the original file and will be consistent with the original file. All observations and examination results will be recorded in a timely, accurate, complete, standardized, and authentic manner in the medical records and correctly filled in the case report forms, and will not be altered at will. If any correction is made, the original record will be kept clear and valid, and the person who corrects the document will sign it with their name and the date. The data from clinical trials will be kept and managed as required. The investigators will keep clinical trial data for 5 years after the end of the clinical trial.
Ethical requirements and informed consent
The protocols were approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2) on August 26th, 2013. Informed consent is provided by the patient or their family after they have indicated that they fully understand the treatment plan.
Adverse events refer to adverse medical events that occur after acupuncture, but may not have a causal relationship with the treatment. If severe adverse events occur, investigators will report details to the principle investigator, ethics committee, and the sponsor within 2 hours. The original data will contain when, in what way (such as telephone, fax, or written document), and to whom the severe adverse events reported. Clinical physicians will report and record adverse events simultaneously. The record will include: a description of the adverse events, time of occurrence, time of termination, extent and frequency of seizure, need for treatment, and if necessary, the physicians will record the treatment given.
Deviations from clinical trial protocols and revisions to clinical trial protocols
All important deviations concerning the inclusion/exclusion criteria, program implementation, patient management, and evaluation protocol will be listed. In the summary report, deviations will be properly summarized according to rehabilitation center and type. For important deviations, we will aim to define the timing, cause, and effect on outcomes. The severity of deviations, as well as the frequency and types of missing values will be described in the summary report along with any other issues and the potential impact on the results will be described.
The information provided by the sponsor, such as the case report form and informed consent documents will be kept confidentially. No person, other than an authorized researcher, may access these documents.
| Results|| |
Trial Status: This Trial Was Registered in the Chinese Clinical Trial Registry (Identifier: Chictr-Ipr-17010490) on January 20th, 2017, and in the Acupuncture-Moxibustion Clinical Trial Registry (www.acmctr.org/index.aspx; Identifier: Amctr-Ipr-17000038) on February 7th, 2017. Patient Recruitment Is Ongoing.
| Discussion|| |
Significance of this study
Our aim is to provide information that will allow caregivers to optimize the timing of acupuncture and rehabilitation therapy in patients with post-stroke hemiplegia. We adopted a multicenter, randomized, controlled approach. In patients with different Brunnstrom stages, the timing of acupuncture at Quchi and Zusanli will be adjusted. By observing the excitability of the motor cortex corresponding to flexors and extensors of the bilateral upper and lower limbs, competitive inhibition in the cerebral hemispheres, and changes in corticospinal long-term potentiation-like plasticity, as well as changes in motor function and daily living ability, we hope to effectively assess the efficacy of acupuncture in combination with rehabilitation therapy and verify the feasibility of this treatment program.
Advantages and limitations of this study
Acupuncture is a type of traditional Chinese medicine. Acupuncture at Quchi and Zusanli has been extensively applied in the treatment of post-stroke hemiplegia in clinical settings. No adverse reactions associated with acupuncture were reported in a large number of clinical applications. Electrophysiological techniques have been widely used to measure cerebral cortex excitability, corpus callosum inhibition, and corticospinal-like plasticity (Moliadze et al., 2003; Lo et al., 2005; Fitzgerald et al., 2006). The three rehabilitation centers belong to third-class first-grade hospitals, have strong scientific research programs, and are key national or provincial centers. The average number of inpatients with stroke in these rehabilitation centers daily is close to 800, and these centers are able to conduct electrophysiological examinations on large numbers of patients simultaneously.
Evidence for contribution to future studies
In this study, we will use electrophysiological techniques to assess whether acupuncture at Quchi and Zusanli enhances the effect of rehabilitation. We hope to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy, and identify the effects of acupuncture at Quchi and Zusanli on cortical excitability and plasticity.
| References|| |
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Case collection, electrophysiological examination and manuscript writing: QQS. Study design and manuscript writing: XKH. Study design: TBY, JT and JX. Case collection, acupucnture and electrophysiological examination: DDX, HHL and BTZ. Rehabilitation therapy: QL.
Conflicts of interest
The protocols have been approved by the Ethics Committee of Shiyan Taihe Hospital (Affiliated Hospital of Hubei University of Medicine) of China (approval No. 2014001-2). All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki.
Declaration of patient consent
The authors certify that they will obtain all appropriate patient consent forms. In the form, the patients will give their consent for their images and other clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed.
Data sharing statement
No data is reported in the article.
Checked twice by iThenticate.
Externally peer reviewed.
Additional file 1: SPIRIT checklist.
[Figure 1], [Figure 2]
[Table 1], [Table 2]