Effect of Acupuncture on Severely Affected Arm-Hand Motor Function on the Chronic Recovery Phase Patients with Post-Stroke Hemiplegia: A Randomized Parallel Controlled Trial

Cronkhite-Canada syndrome is a rare disease presented
with multiple gastrointestinal polyps, alopecia, onchodystrophy,
skin hyperpigmentation, weight loss, diarrhea and intermittent..


Introduction
Stroke is a common acute cerebrovascular disease, and two million new patients are reported in China every year [1]. One study reported that 65% of patients who received post-stroke rehabilitation had arm-hand dysfunction 6 months after stroke [2].
Effect of conventional rehabilitation methods including physical therapy (PT), occupational therapy (OT), is still not satisfactory to the severely affected arm-hand motor function on the chronic recovery phase patients with post-stroke hemiplegia. Some researchers' results suggested that acupuncture combined with rehabilitation training, such as PT, OT may be effective for treating post-stroke neurological impairment and dysfunction such as motor dysfunction, dysphagia [3]. Our previous studies confirmed acupuncture combined with MP (motor practice, abduction of the index finger) could improve motor function of the healthy subjects, there are benefits to starting rehabilitation therapy (defined as PT, OT) as soon as the needle removal when the acupuncture in the affected limbs [4][5][6][7]. The present study aimed to produce new information leading to improved timing for the combined use of acupuncture and modern rehabilitation therapy and identify the effects on severely affected arm-hand motor function on the chronic recovery phase patients with post-stroke hemiplegia.

Materials and Methods
This is a prospective randomized parallel controlled trial, the purpose is to provide an 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 Waiguan on cortical excitability and plasticity. All Informed consent signed by the patient or their family. Patients who meet the criteria will be accepted as study participants, and will be randomized into study groups by a professional statistician (age, sex, height body weight, Body mass index, course of disease, previous history of disease, Mini-Mental State Examination score, Brunnstorm stage classification, history of allergy). The both 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. Patients and assessors will be blinded to group information. On the basis of basic treatment and conventional rehabilitation training. Arm-hand motor extremity impairment before and after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Brunnstrom stage classification.
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 6 consecutive weeks in each group. Acupuncture with training group will be performed 30 minutes acupuncture at Quchi and Waiguan (at the region of arm-hand) at the same time PT was given, while acupuncture priority training group and acupuncture delay training group at the same acupuncture sizes will be performed 30 minutes before PT (priority) or after PT (delay), once a day for 30 minutes, The score is sensitive and reliable. 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 [8]. Basic recovery, significant improvement, and improvement are considered to reflect efficacious treatment. 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 [9]. Arm-hand motor function before and 2-, 4-, 6-week after intervention was measured using the Fugl-Meyer assessment, Wolf Motor Function Test, and Brunnstrom stage classification serve as the outcome measure.
Patients will undergo follow-up assessments for 4-,12-week after the intervention.

Safety
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 DOI: 10.26717/BJSTR.2020.25.004183 19030 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.

Statistical Analysis
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. Treatment effectiveness was evaluated by changes in FMA, WMFT (baseline versus post-intervention) using 1-and 2-sample t tests (within-and between-group comparisons, respectively). Analysis of covariance was used to control for baseline FMA score. McNemar and 2-sample Wilcoxon tests (within-and between-group comparisons, respectively) were conducted. 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. All statistical analyses were conducted by the first author who was blinded to treatment allocation.

Study Participation
Of

Safety
Although common post-stroke adverse events were observed at comparable frequencies in each group, no serious adverse events related to the intervention were observed.

Discussion
Acupuncture is an ancient Chinese therapeutic which has rapidly gained popularity all over the world. A number of randomized controlled trials have indicated its efficacy in the treatment of neurological disorders. Until now, it has been applied to stroke patients with motor deficits and led to a remarkable motor recovery for decades [8]. We have previously explored that electroacupuncture at acupoints and the results indicated that electroacupuncture at the acupoints, especially Quchi and Zusanli, could finally improve the recovery of motor or cognitive functions [9]. Some researchers' results suggested that acupuncture combined with rehabilitation training, including physical therapy (PT), occupational therapy (OT) may be effective for treating poststroke neurological impairment and dysfunction such as motor dysfunction [10]. A new guideline for adult stroke rehabilitation and recovery strongly suggested that there are benefits to starting rehabilitation therapy (defined as PT, OT, and SLT) as soon as the patient is ready and can tolerate it [11]. The time-dependent effects of acupuncture on cortical excitability is might able to induce long-term potentiation (LTP)like plasticity and increase motor learning in human motor cortex, and finally could improve the motor function [15][16][17][18]. We did not use continuous or intermittent stimulation either manually or by electric means once the needle was put in situ. We cannot answer whether strengthening stimulation during the session could have yielded a positive result. Nor can we answer whether acupuncture on sites such as the ear or head could have had a different result.

Conclusion
Our findings suggest that acupuncture may be as a useful alternative to conventional rehabilitation training (such as PT, OT) as an adjuvant to therapist-guided standard rehabilitation, especially to starting rehabilitation therapy as soon as the needle removal when the acupuncture in the affected limbs, and in patients with more severe AH impairment in the Brunnstrom stages I-II. Results of this exploratory study should be interpreted with caution.

Competing Interest Statement
The author denies that he has any intention to obtain any financial interests.