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RESEARCH ARTICLE
Asia Pac J Clin Trials Nerv Syst Dis 2019,  4:3

A reminder incentive system promotes the functional recovery of stroke patients with hemiplegia: A large-sample, single-blind, randomized controlled trial


Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China

Date of Submission19-Sep-2018
Date of Acceptance12-Oct-2018
Date of Web Publication25-Feb-2019

Correspondence Address:
Bin Dong
Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province
China
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2542-3932.251476

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  Abstract 

Background and objectives: Acupuncture and physical rehabilitation training have been shown to promote recovery in stroke patients with hemiplegia. Many patients are unable to consistently complete rehabilitation training because of a variety of factors. The aim of this study was to investigate the effects of wearing a wrist watch with versus without a rehabilitation training-reminder incentive system on locomotor function in stroke patients with hemiplegia.
Participants and methods: This large-sample, single-blind, randomized controlled trial will be performed at the Second Affiliated Hospital of Anhui University of Chinese Medicine, Oxford International Rehabilitation Foundation Limited, and Oxford Brookes University. A total of 200 stroke patients with hemiplegia will be randomly divided into a test group and a control group. The two groups of patients will receive routine medication, acupuncture, and rehabilitation training. Patients in the test group will wear a smart watch with a reminder incentive system that encourages them to complete a set amount of personalized physical exercise tasks, and patients in the control group will wear a watch without a reminder incentive system. This study was approved by the Medical Ethics Committee of the Chinese Clinical Trial Registry on June 16, 2015 (approval No. ChiECRCT-20150034). Study protocol: 1.0. Participants will provide written informed consent.
Results: The primary outcome measure of this study is the differences in the Barthel index measured 3 weeks after discharge (i.e., after 6 weeks of treatment). The secondary outcome measures include neurological deficit scores, National Institutes of Health stroke scale score, Rivermead mobility index, Montreal Cognitive Assessment score, blood pressure, body weight, grip strength, Timed Up and Go Test score, exercise level, EuroQol five dimensions questionnaire score, and adverse events before treatment, after 3 weeks of treatment, and 3 weeks after discharge (after 6 weeks of treatment). In a pilot study, 60 stroke patients with hemiplegia received acupuncture and incentive rehabilitation training. The results showed that in stroke patients with hemiplegia who received elongated needle acupuncture at antagonistic muscles combined with muscle balance exercises, Barthel index and Fugl-Meyer Assessment scale scores increased and Modified Ashworth Scale scores decreased compared with those who received elongated needle acupuncture at antagonistic muscles alone.
Conclusion: We will perform a study involving 200 stroke patients to evaluate whether stroke patients with hemiplegia who receive acupuncture combined with rehabilitation training while wearing a smart watch with a reminder incentive system exhibit better recovery of locomotor function compared with those who receive similar interventions but are not exposed to a reminder incentive system. These experimental data will support the implementation of functional smart device-assisted rehabilitation medical programs.
Trial registration: This study was registered with Chinese Clinical Trial Registry on August 8, 2015 (registration number: ChiCTR-IOR- 15007179).

Keywords: stroke hemiplegia; locomotor dysfunction; electro-acupuncture; rehabilitation training; reminder incentive system; smart watch; artificial intelligence; randomized controlled trial


How to cite this article:
Gao DH, Peng YF, Dong B. A reminder incentive system promotes the functional recovery of stroke patients with hemiplegia: A large-sample, single-blind, randomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis 2019;4:3-13

How to cite this URL:
Gao DH, Peng YF, Dong B. A reminder incentive system promotes the functional recovery of stroke patients with hemiplegia: A large-sample, single-blind, randomized controlled trial. Asia Pac J Clin Trials Nerv Syst Dis [serial online] 2019 [cited 2019 May 24];4:3-13. Available from: http://www.actnjournal.com/text.asp?2019/4/1/3/251476




  Introduction Top


Research background

Stroke is a general term for acute cerebrovascular disease that is mainly characterized by fainting, unconsciousness, hemiplegia, slanting of the mouth, and abnormal language production, and has high rates of morbidity, mortality, and recurrence, as well as a high rate of complications (Goldstein and Simel, 2005). Stroke, cardiovascular disease, and cancer are considered to be the three major diseases that threaten human health (Donnan et al., 2008). An epidemio-logical survey found that nearly 8 million people develop strokes each year (GBD 2015 Disease and Injury Incidence and Prevalence Collaborators, 2016). At present, the incidence and mortality rates of stroke in China are the highest in the world, with about 2 million new cases of stroke per year and a stroke mortality rate that is 4–5 times that in European and American countries and 3.5 times that in Japan (Wang et al., 2017). Most stroke survivors who receive an early diagnosis experience long-term hemiplegia. A previous study reported that about 85% of stroke patients experience unilateral upper limb dysfunction (Broeks et al., 1999), which persists in 55–75% of stroke patients 3–6 months after onset (Wilkinson et al., 1997; Kwakkel et al., 1999). This not only greatly affects patient quality of life, but also imposes a heavy economic burden on families and society (Liu et al., 2011). At present, the annual cost of treating stroke in China is estimated to be more than 12 billion yuan RMB, and the annual expenditure, including direct and indirect costs, is close to 20 billion yuan RMB (Wang et al., 2017). Although stroke can occur at any age, aging is a main risk factor for stroke. About two thirds of stroke patients experience their first stroke at 60 years of age or older (Koton et al., 2014). It is estimated that by 2030, people over 60 years of age will account for 25% of the total population of China (State Council, 2016). The current drugs used to treat post-stroke hemiplegia mainly work to provide the brain with increased nutrition, improve the blood supply to the brain, and increase the energy supply to the brain (Scheidtmann et al., 2001; Chollet et al., 2011; Huang et al., 2016). However, few drugs are used to improve limb locomotor function in stroke patients. Therefore, treatment plans that reduce rates of disability, restore limb motor function, and improve quality of life in stroke patients are of great clinical and social significance. Restoring inde-pendent walking and improving the activities of daily life are the primary goals of rehabilitation for patients with post-stroke deficits in neurological function.

Brain plasticity and brain function reorganization appear to underlie recovery in individuals with brain injury (Hara, 2015). When the brain is partially damaged, the body makes corresponding changes to compensate for the impaired brain function. This may not only occur in the damaged lateral hemisphere, but may also involve changes in the function of the contralateral hemisphere (Di Pino et al., 2014). Treatments such as acupuncture appear to affect functional reorganization (Li and Wang, 2013). Thus, acupuncture appears to be a potential treatment for post-stroke hemiplegia. Acupuncture treatment for post-stroke hemiplegia has a long history in China, and it is regarded as having a curative effect. Rehabilitation techniques for post-stroke hemiplegia mainly include neurophysiological developmental therapy, motor imagery therapy, mandatory exercise therapy, and exercise re-learning techniques. Such rehabilitation techniques have been shown to improve the prognosis of stroke patients with hemiplegia, effectively improve patient locomotor and cognitive function, promote the recovery of neurological function, improve quality of life, and greatly decrease the degree of disability (Husemann et al., 2007; Borisova and Bohannon, 2009; Cakar et al., 2010). However, many patients miss rehabilitation training sessions due to the physical and metal inconvenience, and this can greatly affect the efficacy of the treatment. Prior to trial registration, the authors searched the CNKI database and analyzed the efficacy of different rehabilitation therapies in the treatment of post-stroke hemiplegia [Table 1].
Table 1: Trials examining the efficacy of different rehabilitation therapies in the treatment of post-stroke hemiplegia

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With new advances in technology, a variety of smart wearable devices have gradually entered our lives. Among them, smart watches are popular because they are affordable and easy to use. Smart watches can help patients to complete rehabilitation plans and thus increase the efficacy of rehabilitation training. Specifically, they can be used to conduct automatic monitoring of stroke patients and to deliver information that is part of an incentive system to remind patients to actively participate in rehabilitation treatment.

Study objective

This large-sample, single-blind, randomized controlled trial will compare the efficacy of comprehensive rehabilitation on recovery between post-stroke hemiplegia patients who wear a smart watch with a reminder incentive system and those who wear a smart watch without a reminder incentive system.


  Participants and Methods Top


Study design

A multi-center, single-blind, randomized, controlled trial.

Study setting

Second Affiliated Hospital of Anhui University of Chinese Medicine, China.

Investigator qualifications

The Second Affiliated Hospital of Anhui University of Chinese Medicine is a grade III, level A hospital. Each investigator should have a doctorate or master's degree, a professional title of associate chief physician or higher, and at least 10 years of clinical experience.

Study population

Recruitment

Posters for the recruitment of stroke patients with hemiplegia will be placed in the clinics and wards of the First and Second Departments of Rehabilitation at the Second Affiliated Hospital of the Anhui University of Chinese Medicine in China. Interested patients or their family members can contact the project manager via attending physicians or via telephone, e-mail, or Wechat.

Eligibility criteria

Stroke patients who are scheduled to receive treatment in the First and Second Departments of Rehabilitation at the Second Affiliated Hospital of the Anhui University of Chinese Medicine will be considered for inclusion in this study.

Inclusion criteria: Stroke patients who are scheduled to receive treatment at the First and Second Departments of Rehabilitation at the Second Affiliated Hospital of the Anhui University of Chinese Medicine will be considered for inclusion if they meet the following criteria, which were designated by a group of experts: a) fulfillment of the diagnostic criteria for stroke as per the clinical neurology guidelines (Chinese Medical Association, 2007); b) fulfillment of the diagnostic criteria for stroke as per the Diagnostic Efficacy Evaluation Standard for Stroke used by Chinese medicine practitioners (Encephalopathy Emergency Research Collaboration Group of Chinese Medicine Administration, 1996); c) first onset of stroke, onset time ≤ 4 months, and first admission for treatment; d) consciousness, steady vital signs; e) good cognitive function with intact communication skills including the ability to understand therapist instructions and cooperate with the training protocol; f) 40–75 years of age and either sex; and g) provision of written informed consent.

Exclusion criteria: Patients presenting with one or more of the following criteria, which were designated by a group of experts, will be excluded from the study: a) neurological impairment caused by a brain tumor, traumatic brain injury, brain parasite or associated disease, heart disease, or metabolic disease; b) transient cerebral ischemia or reversible neurological impairment; c) second stroke event or second admission for stroke treatment; d) severe primary diseases of the heart, liver, kidney, hematopoietic system, or endocrine system, or mental illness; e) poor consciousness and impaired communication; f) women who are lac-tating or pregnant; and g) participation in other clinical trials.

Withdrawal criteria: Patients presenting with one or more of the following criteria will be withdrawn from this study: a) poor compliance; b) severe adverse reactions; c) severe diseases of the heart, liver, kidney, hematopoietic system, or endocrine system; and d) lost to follow up.

All patients will receive medication and related laboratory examinations without charge as well as clinical follow-up as-sessments. The trial will provide patients with clinical trial liability insurance such that an insurance company will bear the treatment costs and offer financial compensation for trial-related injuries or deaths.

Interventions

All patients will receive routine medication and acupuncture treatment for 6 days (treatment from Monday to Saturday) per week, for a total of 3 weeks.

Routine medication: All patients will undergo conventional treatment to activate brain cells, promote blood circulation, and dissipate blood stasis, along with other symptomatic treatments.

Acupuncture: The goals of the acupuncture treatment will be to dredge the governor vessel and to regulate patient mentality with respect to prescribed medication (Wang et al., 2010). The patients will be asked to lie in a lateral position with their limbs placed in a conformable position. An elongated needle (φ 0.35 mm × 25–50 mm, Suzhou Medical Equipment Factory, Suzhou, Jiangsu Province, China) will be inserted and then the twirling reinforc-ing-reducing manipulation will be used. The needle will be left in place for minutes until the patient reports experiencing the sensation of needling. Fifteen minutes later, a 2-minute twirling reinforcing-reducing manipulation will be performed. The total duration of the manipulation will be 30 minutes. The elongated needles will be slowly inserted at the Fengfu (GV16) and Yamen (GV15) acupoints towards the lower mandible until a depth of 0.5–1.0 cun has been reached (1 cun equals the width of the interphalangeal joint of the patient's thumb). Another needle will be slowly inserted at the Fengchi (GB20) acupoint towards the tip of the nose until a depth of 0.8–1.2 cun has been reached. Acupuncture at the other acupoints will be performed vertically, and the depth of acupuncture will be varied according to the patient's muscle mass. The acupoints involved in the twirling reinforcing and reducing manipulation are shown in [Table 2].
Table 2: Acupoints involved in the twirling reinforcing and reducing manipulation and corresponding symptoms

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Other adjuvant therapies

Cupping therapy: Cups will be positioned on the Yangming meridian of the upper and lower limbs and left in place for 5–10 minutes, once per day.

Massage therapy: The upper and lower limbs on the affected side will be massaged and each joint will be released. Massage sessions will be 30 minutes long and will take place once per day, 6 days per week (from Monday to Saturday), for a total of 3 weeks.

Rehabilitation training: After a functional evaluation, a rehabilitation protocol will be developed with the expectation that the patient will complete the exercises once per day.

Limb exercises based on neurophysiological development therapy and re-learning techniques: Exercises included: i) placement of unaffected limbs; ii) passive movement of the joints of limbs on the affected side; iii) sensory stimulation; iv) use of the jointed reaction and movement of the upper and lower limbs to induce movement in the affected limbs; v) bed training including bridge movement, knee movement, double-swing movement, upper limb assistive movement, and posture change; vi) upper limb training including induction and control of the flexion and extension of the elbow joint, supination of the forearm, flexion and extension of the wrist joint, thumb abduction, and finger-to-finger training; vii) lower limb training including induction of the hip and knee movements in the supine and prone positions as well as corresponding control positions and prevention of foot drop and foot varus; viii) balance training including sitting up, sitting, and standing; ix) gaiting training including touching the heel to the floor; and x) training in the activities of daily living.

Homework: Limb coordination training and activities of daily living-related training

Physical therapy factor: Treatment with low frequency therapeutic instrument, intermediate frequency therapeutic instrument (Xiang yu yiliao) and Magneto-Vibratoey Therapeutic Instrument (YaSi YS2004).

Differential interventions

Test group: The wristband watch that will be worn by the patients (UK Oxford International Rehabilitation Foundation) has a daily automatic reset for the personalized target amount of exercise and a reminder incentive system to constantly remind the patient to achieve a personalized target amount of exercise.

Control group: The wristband that will be worn by the patients (UK Oxford International Rehabilitation Foundation) does not have reminder or incentive functions in the built-in program. It does not remind the patient to carry out rehabilitation training. The wristband only records the total daily activity of the patient.

Outcome measures

Primary outcome measure

We will evaluate differences in the Barthel index before treatment versus 3 weeks after discharge (i.e., after 6 weeks of treatment). The Barthel index is a commonly used index to evaluate the ability of daily activities from the domains of feeding, bathing, grooming, dressing, bowel functions, bladder, toilet use, transfer, mobility, and stair mobility with a total score of 105. Lower scores indicate poorer ability with respect to daily activities (Duffy et al., 2013).

Secondary outcome measures

The following outcome measures will be evaluated before treatment, after 3 weeks of treatment, and 3 weeks after discharge (after 6 weeks of treatment).

Neurological deficit score: We will use the neurological deficit score to evaluate consciousness, horizontal gaze function, facial paralysis, speech, upper limb muscle strength, hand muscle strength, lower limb muscle strength, and walking, with a full score of 45. Higher scores indicate more severe neurological deficits (the Fourth National Academic Conference on Cerebrovascular Disease, 1996).

National Institutes of Health Stroke Scale (NIHSS) score: The NIHSS is used to evaluate neurological deficits, including level of consciousness, horizontal eye movement, visual field test, facial palsy, motor function in the arm, motor function in the leg, limb ataxia, sensory function, language, speech, memory extinction, and inattention. Higher NIHSS scores indicate more severe neurological deficits (Kwah and Diong, 2014).

Rivermead mobility index: This measure is used to evaluate the degree of dyskinesia and the progression of treatment. The 15 items include turning over in bed, moving from a lying to sitting position, balancing while sitting, moving from a sitting to standing position, standing unsupported, transfer, walking inside (with an aid if necessary), moving up stairs, walking outside (on even ground), walking inside (with no aid), picking up an object off the floor, walking outside, bathing, moving up and down four steps, and running, with a full score of 15. Lower scores indicate more severe disability (Park and Kim, 2016).

Montreal Cognitive Assessment (MOCA) score: The MOCA is used to evaluate cognition, with a full score of 30. Lower scores indicate poorer cognition (Zuo et al., 2016).

Blood pressure: Blood pressure will be measured using a blood pressure meter (Jiangsu Yuyue Medical Equipment Co., Ltd., Danyang, Jiangsu Province, China; license No. 20010089 of Jiangsu Food & Drug Instrument Administration).

Body weight: Patients will be weighed using a balance scale (Wuxi Weigher Factory Co., Ltd., Wuxi, Jiangsu Province, China).

Grip strength: Grip strength will be measured using a dynamometer (Guangdong Zhongshan Xiangshan Group Co., Ltd., China).

Timed Up and Go Test (TUG) score: The TUG test is a simple test used to assess a participant's gait. During the test, the participant wears their regular footwear and sits in an armchair with a seat height of 45 cm and an armrest height of 20 cm. The participant is asked to sit back in the chair with their hands on the armrests. If a mobility aid will be used, the participant holds it in the hands. A marker (colored strip or otherwise distinct marker) is placed on the ground 3 meters away from the seat. When the tester gives the command “ready”, the participant is expected to rise from the chair and walk 3 meters in a natural fashion to the marker, where they are then expected to turn around, walk back to the chair, and sit down. During the test, no physical assistance is permitted. Before testing, the participant should complete one or two practice trials to ensure that they fully understand the test procedure. Participant performance is scored according to their gait and the risk of falling: 1 = normal, 2 = very slightly abnormal, 3 = mildly abnormal, 4 = moderately abnormal, 5 = severely abnormal (Chan et al., 2017).

Amount of exercise: The amount of exercise per day will be recorded by the smart watch worn by the participant.

EuroQol five dimensions questionnaire (EQ-5D) score: The EQ-5D is a measure of quality of life. It consists of five dimensions including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Lower EQ-5D scores indicate poorer quality of life (Nagy et al., 2018).

Adverse events: The chi-square test/Fisher's exact test will be used to compare the incidence of adverse events between the test and control groups. The details of the adverse events will be listed in a table, and the severity of the adverse events will be analyzed.

Acupuncture-related adverse events include broken needles, stuck needles, fainting, unbearable acupuncture pain (Visual Analogue Scale (VAS) score ≥ 8), severe post-needling pain lasting more than 2 hours (VAS score ≥ 4, full score of 10), local hematoma, and infection or abscess. The average severity and duration of other post-stroke discomforts (fatigue, palpitations, dizziness, headache, and insomnia after acupuncture, VAS score ≥ 4 for each symptom) as well as other unforeseen adverse events will be monitored. Acupuncture-related safety indicators will be described and assessed between the two groups.

Outcome measures are shown in [Table 3].
Table 3: Schedule for primary and secondary outcome measures

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Sample size

The sample size was calculated based on a power analysis of the results of a pilot study. Patients were divided into a test group and a control group. To achieve statistical significance, G*Power software (http://www.gpower.hhu.de/) was used to calculate the sample size. Alpha = 0.05 and power = 0.95 values were selected during the power analysis. The outcomes were measured at three time points, i.e., before treatment, after 3 weeks of treatment, and 3 weeks after discharge (after 6 weeks of treatment). The differences in outcome measures between the two groups was significant when the effect size was 0.12, and the required sample size was n = 182. The results of a pilot study revealed that 10% of the patients were lost. To ensure statistical significance, we will add 10% more patients in the proposed study. Thus, a total of 200 patients will be included. Because of the large number of patients included and the long trial period, interim analysis is necessary to monitor the treatment safety and efficacy. As the interim analysis will include data and results that have been unblinded, the investigators who perform the interim analysis should not directly participate in the clinical trial, which will be highly blinded. The investigators will only receive information about whether to continue the trial and instructions if it is necessary to modify the study protocol. Subsequent clinical studies will be adjusted based on the results of the interim analysis, including the possibility of terminating the trial.

The possibility of terminating the trial will be considered if the following conditions are encountered: multiple participants terminate the trial because of unacceptable adverse reactions, adverse reactions with an incidence and severity revealing more harm than good, non-ideal participant recruitment, inaccurate or imperfect data recorded, a request from the sponsor for safety reasons.

Randomization

Complete randomization will be used. An investigator will be responsible for randomization and he/she will not par-ticipate in participant recruitment. Participants will be numbered 1–200 according to recruitment sequence. The par-ticipants with an even number will be included in the test group, and those with an odd number will be placed in the control group. The digital randomization table will be signed and kept in a closed envelope. After grouping, the par-ticipants will be assigned corresponding identifiers.

Blinding

The evaluators and statistical analysts will be blind to the study design. The participants will be asked to remove their wrist watches during assessments to maintain group anonymity when interacting with the assessors. The participants will not be informed of their group status during the study, but they will know whether their wrist watch has a reminder and incentive system. Clinicians and rehabilitation therapists will not be blind to group status, as they will know whether each participant's wrist watch has a reminder and incentive system. These medical professionals will provide the participants with treatment and rehabilitation training as per the study protocol.

Ethics

This study will be performed in strict accordance with the Declaration of Helsinki and applicable laws and regulations in China. The study was approved by the Hospital Ethics Committee of the Clinical Trial Registration system (approval No. ChiECRCT-20150034) (Additional file 1) [Additional file 1]and registered with the Chinese Trial Registration system on August 8, 2015 (registration No. ChiECRCT-20150034), study protocol: 1:0. After the study has begun, any modifications to the study protocol or informed consent procedure should be approved by the Hospital Ethics Committee of the Clinical Trial Registration system.

Informed consent

Before recruitment, the clinicians from the study team will explain the study details to the patients and the patients will be asked to sign an informed consent form (Additional file 2) [Additional file 2]. The preparation of this manuscript followed the CONsolidated Standards of Reporting Trials (CONSORT) guidelines (Additional file 3) [Additional file 3].

Statistical analysis

Randomization of the study population: According to the intention-to-treat principle, all randomized participants will be statistically analyzed. Two-tailed tests will be performed, and a level of P < 0.05 will be considered statistically significant. Measurement data will be expressed as the mean ± SD, median, maximum value, and minimum value. The count data and ranking data will be expressed as the number of cases and percentages.

Comparison of data between groups: Paired t-tests or nonparametric tests will be used to compare the measurement data. The chi-square test or Fisher Exact test will be used to compare the count data. A nonparametric test will be used to compare the ranking data. Paired t-tests or nonparametric tests will be used to compare the measurement data with the baseline data, and nonparametric tests will be used to compare the count data with the baseline data.

Detailed methods: Case distribution and rate of loss to follow up: The case distribution in each study center will be described. The rate of loss to follow up for each group and the total rate of loss to follow up because of adverse events will be calculated and compared between the test and control groups using the Fisher exact test.

Demographic data and baseline data analysis: The demographic data and baseline indicators will be compared among the test and control groups.

Participant compliance: The two groups of participants will be evaluated to determine whether they received treatments with the prescribed courses and times according to the study protocol.

Efficacy analysis: Efficacy analyses will be performed in randomized populations. After randomization, the partici-pants those who will not receive any treatment and those who will receive treatment but without treatment efficacy will be considered lost, and they will be included in the efficacy analysis.

Management of missing data: Multiple imputation will be used to generate estimates for the missing data. An instru-mental variable approach will be used to handle data non-compliance.

Efficacy indicators: Analyses of covariance will be used to compare normally distributed data. The nonparametric test will be used to compare non-normally distributed data.


  Results Top


Trial flow chart

A flow chart of a large-sample single-blind, randomized controlled trial is shown in [Figure 1]. A total of 100 eligible patients per group will be included in the final analysis.
Figure 1: Study flow chart.

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Patient recruitment

According to patient admission at the First and Second Departments of Rehabilitation, Second Affiliated Hospital of Anhui University of Chinese Medicine of China, we anticipate that 200 patients will be included in the study by September 1, 2019.

Baseline data collection

Prior to recruitment, patient information including sex, age, onset time, cognitive function, and previous medical history will be collected.

Anticipated outcomes

We will collect data regarding the Barthel index, neurological deficit scores, National Institute of Health stroke scale scores, Rivermead mobility index, Montreal Cognitive Assessment scores, blood pressure, body weight, grip strength, Timed Up and Go Test scores, exercise level, EuroQol five dimensions questionnaire scores, and adverse events before treatment and during the follow up.

Possible adverse events

Possible adverse events during the trial include fatigue, palpitations, dizziness, headache, insomnia, inattention, muscle and ligament soft tissue strain, and acupuncture-related broken needles, stuck needles, fainting, unbearable acupuncture pain, local hematoma, and infection or abscess. Any adverse events should be reported to the Office of Science Research, Second Affiliated Hospital of Anhui University of Chinese Medicine within 24 hours. The original adverse event report and fax confirmation forms must be kept in the research center together with the case report form.

Results of a pilot study with a small sample-size

In a pilot study performed in 2010, 60 stroke patients with hemiplegia were randomly assigned to receive either elongated needle acupuncture at antagonistic muscles combined with muscle balance exercises (test group) or elongated needle acupuncture at antagonistic muscles alone (control group). All patients were included in the final analysis, and no patients dropped out of the study. We compared baseline information and treatment efficacy between the test and control groups.

Baseline information for 60 patients

We found no significant differences in patient age, course of disease, sex, or disease category between the two groups (P > 0.05; [Table 4]).
Table 4: Clinical data of stroke patients with hemiplegia included in a pilot study

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Daily living ability for 60 patients

In the test group, the Barthel index of stroke patients with hemiplegia was significantly increased after treatment compared with before treatment (P < 0.01). After treatment, the Barthel index in the test group was significantly higher than that in the control group (P < 0.01; [Table 5]).
Table 5: Effects of elongated needle acupuncture at antagonistic muscle combined with muscle balance exercises versus elongated needle acupuncture at antagonistic muscle alone on patient's daily living

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Muscle spasm on the affected side for 60 patients

Compared with before treatment, scores on the modified Ashworth Scale, which was used to evaluate muscle spasm in the affected side, was significantly lower after treatment in the two groups, (P < 0.01). After treatment, the modified Ashworth Scale score in the test group was significantly lower than that in the control group (P < 0.01; [Table 6]).
Table 6: Effects of elongated needle acupuncture at antagonistic muscle combined with muscle balance exercises versus elongated needle acupuncture at antagonistic muscle alone on patient's muscle spasm on the affected side

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Improvement in muscle spasm on the affected side for 60 patients

After treatment, muscle spasms in the test group were significantly improved compared with that the control group (P < 0.01; [Table 7]).
Table 7: Effects of elongated needle acupuncture at antagonistic muscle combined with muscle balance exercises versus elongated needle acupuncture at antagonistic muscle alone on patient's affected side muscle spasm improvement

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Lower limb locomotor function on the affected side for 60 patients

Compared with before treatment, scores on the Fugl-Meyer Assessment scale, which is used to evaluate lower limb locomotor function in the affected side, were significantly increased in the two groups after treatment (P < 0.01). After treatment, Fugl-Meyer Assessment scale scores in the test group were significantly higher than those in the control group (P < 0.01; [Table 8]).
Table 8: Effects of elongated needle acupuncture at antagonistic muscle combined with muscle balance exercises versus elongated needle acupuncture at antagonistic muscle alone on patient's lower limb locomotor function on the affected side

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  Discussion Top


Study limitations

This study has several limitations. First, the rehabilitation treatments used by the patients in the trial are different. At the same time, the severity of post-stroke hemiplegia differs greatly. Therefore, there are valid doubts about the comparability between two such groups of patients. In future studies, we hope to compare patients with consistent baseline data who receive the same rehabilitation treatments.

Treatment promotability

The results of this study will provide evidence to validate whether wearing a smart watch with a reminder and incentive system can promote the recovery of locomotor function in stroke patients with hemiplegia, and help clinicians discern whether a smart device can assist in increasing adherence to medical programs.

Interpretation

At present, a number of rehabilitation measures in clinical practices promote rehabilitation in stroke patients with hemiplegia (Scheidtmann et al., 2001; Husemann et al., 2007; Borisova and Bohannon, 2009; Cakar et al., 2010; Chollet et al., 2011; Huang et al., 2016). However, physical and mental inconvenience may preclude some patients from completing the full course of acupuncture and limit their adherence to the necessary rehabilitation training plan made by the clinician. This has a negative effect on rehabilitation. Previous studies have mainly compared the effects of different treatment methods on neurological function in stroke patients with hemiplegia (Scheidtmann et al., 2001; Husemann et al., 2007; Borisova and Bohannon, 2009; Cakar et al., 2010; Chollet et al., 2011; Huang et al., 2016). In this study, the smart watch reminder and incentive system will remind the patients to actively participate in the rehabilitation treatment, and we hypothesize that this will assist in the completion of acupuncture sessions in combination with rehabilitation.


  Data Authenticity Management Top


Data collection

Patients will be recruited in the hospital and baseline data will be collected directly. Outcome measures will be obtained through subsequent hospital visits. All personnel responsible for data collection will receive related training to ensure consistency of evaluation. During the trial, patient compliance should be encouraged to reduce dropouts. For dropouts, investigators should attempt to conduct a follow-up assessment via telephone. Follow-up assessments via telephone can be used as a complementary means of ensuring patient compliance. Each patient should provide two telephone numbers for future use. According to the intention-to-treat principle, for those who withdraw from the trial, the data from the last test will be used as the test results.

Data management

Each eligible patient must provide informed consent. All items on the case report form should be filled in. Each case report form should be kept by the investigators. A duplicate copy of the case report form will be kept by the data manager to establish a database. After accuracy confirmation, all information recorded on the case report form will be input in the computer using a double-entry strategy. Case report forms will be numbered and archived. Electronic data will be stored in categories and saved on multiple backups to avoid damage. All original files should be kept for a period of time within the corresponding regulations.

Data quality control

Study protocol selection

Randomization will be performed by the Department of Science Research, Second Affiliated Hospital of Anhui University of Chinese Medicine. The randomization scheme and various parameters designated during the process of scheme generation will be blinded, kept in a closed envelop, and signed by the personnel re-sponsible for randomization. These data will then be preserved by the data manager, who will not participate in the study. The randomization scheme will be only accessible by the data administrator with highest administration privileges.

Strict participant restrictions

Strict adherence to the inclusion and exclusion criteria is important for reducing bias. Definite inclusion and exclusion criteria are developed to restrict participants within a certain range and reduce the differences between patients. This contributes to the possibility of developing an objective conclusion regarding the outcome measures.

Blind measurement and judgment results

The smart watches will all have the same appearance. The clinicians will communicate with the patients to obtain individual feedback. A person blind to the grouping will evaluate the treatment efficacy and safety and record the related information. The obtained data will be statistically analyzed by a third party to ensure authenticity.

Quality control personnel

This study will have a two-level quality control system with a level 1 quality control check and level 2 quality control monitoring. The level 1 quality control check will be performed by at least one person who will be designated by the investigators and will not participate in treatment implementation. The level 2 quality control monitoring will be conducted by at least three persons who will be designated by the study team and will not participate in treatment implementation.

Quality assurance

Prior to the clinical trial, a special clinical training meeting will be held to conduct unified training for the clinical investigators. At the same time, a preliminary clinical trial will be performed. The study protocol and standard operation procedure will be described to familiarize each investigator with the study process and details, thus ensuring data reliability. The investigators should sign a statement regarding the trial results.

Measures to increase patient compliance

Patient compliance will be evaluated according to the number of treatments received by each patient.

To achieve better patient compliance and ensure that the number of patients included in the final analysis is not less than 50% of the total number of patients, the following measures will be used: the principle of voluntariness and provision of an informed consent form; improvement and maintenance of good patient compliance from the perspectives of medical treatment level, hospital environment, and medical costs; a full explanation of the treatment details to each patient, including the objective and necessity of each examination, treatment procedure, and re-evaluation, and achievement of patient agreement and cooperation; careful records of contact information for later follow-up assessments.

In addition, the use of a patient manual and daily reminders from medical staff may increase patient compliance. A minority of patients who have a poor compliance history should be emphasized in terms of communication and frequent reminders.

Monitoring

The clinical research associate will monitor the case report form and medical records for each patient during and after the trial. Study bias related to patient recruitment and study implementation should be recorded. A clinical quality control check will be conducted every 2 months by the clinical research associate. Trial progress will also be reported to the ethics committee and simultaneously updated in the registration database.

Confidentiality

The results and relevant data from this study will be recorded on case report forms, which will be kept confidential by a designated person.

Competing interest statement

This study is supported by self-fundraising. All wrist watches will be provided by the Oxford International Rehabilitation Foundation and Oxford Brookes University, who assisted with the study design. All authors declare that they have not received relevant financial support and that there are no conflicts of interest.

Data sharing statement and result dissemination

After de-identification (text, tables, figures, and appendices), the individual participant data that underlie the results reported in this article will be available indefinitely at www.figshare.com following publication. Other original data will be available from the corresponding author. The results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal.

Date of registration: August 8, 2015.

Recruitment time: September 1, 2015 to September 1, 2019.

Study completed: September 1, 2020.

Trial status: Recruiting.

Additional files

Additional file 1: Ethics Committee Approval (in Chinese).

Additional file 2: Informed Consent Form (in Chinese).

Additional file 3: CONSORT checklist.

Acknowledgements

The authors would like to thank the Oxford International Rehabilitation Foundation and Oxford Brookes University for their assistance in study design and provision of wrist watches.

Author contributions

All authors contributed to study design and manuscript writing.

Conflicts of interest

None declared.

Financial support

None.

Institutional review board statement

This study was approved by the Medical Ethics Committee of the Chinese Clinical Trial Registration (approval No. ChiECRCT-20150034). This study is performed in accordance with the relevant ethical requirement of Declaration of Helsinki. Informed consent of the study procedure will be obtained from all participants or their legal guardians.

Informed consent statement

The authors certify that they have obtained all appropriate patient consent forms. In the form the patients have given their consent for patients’ 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.

Reporting statement

This study followed the CONsolidated Standards Of Reporting Trials (CONSORT) Statement.

Biostatistics statement

The statistical methods of this study were reviewed by the biostatistician of Second Affiliated Hospital of Anhui University of Chinese Medicine of China.

Copyright license agreement

The Copyright License Agreement has been signed by all authors before publication.

Data sharing statement

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be available. Study protocol and informed consent form will be available immediately following publication, without end date. Results will be disseminated through presentations at scientific meetings and/or by publication in a peer-reviewed journal. Anonymized trial data will be available indefinitely at www.figshare.com.

Plagiarism check

Checked twice by iThenticate.

Peer review

Externally peer reviewed.

Open access statement

This is an open access journal, and articles are distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as appropriate credit is given and the new creations are licensed under the identical terms.

S-Editors: Yu J, Li CH; L-Editor: Song LP; C-Editor: Jia Y[35]



 
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