Clinical Effects Of Early Rehabilitation Training At Different Time In Patients With Dysphagia After Stroke: Study Protocol For A Multicenter Randomized Controlled Trial

doi:10.21203/rs.3.rs-989007/v1

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Research Article

Clinical Effects Of Early Rehabilitation Training At Different Time In Patients With Dysphagia After Stroke: Study Protocol For A Multicenter Randomized Controlled Trial

https://doi.org/10.21203/rs.3.rs-989007/v1

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posted 08 Mar, 2022

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Background: Stroke is characterized by high morbidity, high mortality, high disability rate, high recurrence rate and heavy economic burden. Post-stroke dysphagia (PSD) is one of the common complications of stroke, which can easily lead to adverse consequences such as repeated aspiration, malnutrition, pulmonary infection, and even asphyxia, and seriously affect the quality of life and prognosis of patients. For PSD patients, scientific and practical early rehabilitation measures can better improve the swallowing function, but the best time for early rehabilitation of PSD patients has not been reported. Therefore, we report on a randomized controlled trial (RCT) in which patients were offered early rehabilitation training using rehabilitation exercises for dysphagia after stroke. This protocol was written according to the SPIRIT 2013 Statement.

Methods: This is a multi-center and pragmatic RCT. On the basis of sample size calculation, 180 patients with acute ischemic stroke were randomly enrolled from 3 different hospitals and divided into 4 groups: 1 control group and 3 experimental groups. The control group only received clinical routine electrical stimulation treatment, and the experimental group added rehabilitation exercise on this basis. According to the different starting time of rehabilitation exercise training after the onset of stroke, they were divided into 0-3 days group, 4-7 days group and 8-14 days group. Rehabilitation exercise training lasts for 4 weeks, once in the morning and once in the afternoon, about 30 minutes each time. Primary outcomes were the degree of improvement in patient swallowing function and efficacy assessment. Secondary outcomes, including incidence of choking, pulmonary infection, quality of life, and training compliance rates, were assessed at baseline and 4 weeks after intervention initiation.

Discussion: The purpose of this study was to investigate the improvement of swallowing function in PSD patients after early rehabilitation training at different time.

Trial registration: chictr.org.c, ID: ChiCTR2000029149. Full Registration on 1 May 2021. https://www.chictr.org.cn/ ChiCTR2000029149.

Early rehabilitation

Ischemic stroke

Early rehabilitation

RCT

Study protocol

Stroke, as the second leading cause of death and disability in the world, is characterized by high morbidity, disability, mortality and recurrence, and is one of the major global public health problems ^[1]. From 1990 to 2016, although global stroke mortality, morbidity and disability rates declined, the burden of disease remains high and is likely to continue to increase ^[2]. In China, the burden of stroke is also severe, and stroke is still the first cause of death and disability among adults in China ^{[3, 4]}. Post-stroke dysphagia (PSD) is one of the common complications of stroke, with an incidence of 51% ~ 73% ^[5]. It can be manifested as choking and recurrent fever when drinking water, and in severe cases may induce aspiration, pneumonia, dehydration, malnutrition, etc., which seriously affects the quality of life of patients. Sometimes it even endangers the lives of patients ^[6].

Stroke rehabilitation mainly includes subacute rehabilitation and early rehabilitation. Subacute rehabilitation is rehabilitation nursing 7 days to 3 months after stroke onset ^[7], early rehabilitation refers to the rehabilitation intervention measures starting from 1 day to 7 days after the onset of stroke^[8]. Some scholars also put forward that rehabilitation intervention within 1 day of stroke onset, that is, ultra-early stage, may have great application prospects in the recovery of neurological function ^[9]. The world Health Organization (WHO) recommended early recovery time for stroke patients: 48h after onset, with stable vital signs and no progression of neurological symptoms ^[10]. Therefore, the timely of early rehabilitation intervention may be more acceptable in clinical practice.

The early rehabilitation of stroke patients is based on the principle of neuroplasticity ^[11]. Early rehabilitation training for PSD patients can effectively prevent disuse atrophy of oropharyngeal muscle group, so that patients can safely absorb the required nutrients and water ^[12]. Guidelines for rehabilitation of stroke ^{[13, 14]}the importance of early rehabilitation for stroke patients was emphasized. Studies haveearly rehabilitation of PSD patients significantly improved swallowing function and reduced the incidence of adverse outcomes ^[15]. Tang etc. ^[16] conducted early rehabilitation intervention for 136 PSD patients, and the control group was added with feeding management on the basis of routine rehabilitation training. The results showed that after active early rehabilitation treatment, more than 85% of PSD patients' swallowing disorders were recovered and reduced, and the incidence of stroke-related pneumonia was reduced. In the study of Liang ^[17] et al. 62 patients with acute PSD underwent feeding posture adjustment and empty swallowing and other training. It was found that 71.8% of patients had a significant recovery of swallowing function within 2 days after swallowing rehabilitation intervention, while only 30% of patients in the control group had an improvement of swallowing function. Langhorne^[18] et al. compared the effects of early rehabilitation and general rehabilitation on stroke patients in a systematic evaluation, and data analysis showed that early rehabilitation resulted in higher scores of daily living ability and slightly shorter hospital stay. Therefore, timely intervention measures for patients with dysphagia after stroke are of great significance for their early rehabilitation.

Currently, there are no targeted drugs for rehabilitation treatment of PSD patients, and rehabilitation training has a relatively positive effect on the improvement of swallowing function. Many treatments for post-stroke dysphagia have been used clinically, including transcranial magnetic stimulation^[19], neuromuscular electrical stimulation^[20], acupuncture^[21],acupoint massage^[22], ice stimulation^[23], balloon dilation^[24], myoelectric biofeedback therapy^[25], swallowing disorders rehabilitation exercises^[26]. And so on, the combined application is better than using alone ^[11].

Although a large number of studies at home and abroad ^[27–29] show thatrehabilitation training has a significant effect on PSD patients, but the existing rehabilitation training mode is relatively single and lack of system, and patients' compliance and enthusiasm are not high, which reduces the effect of rehabilitation training. And research has shown that ^[30] early rehabilitation is more beneficial to the recovery of swallowing function in PSD patients, but there are few reports on the optimal timing of early rehabilitation in PSD patients.

We have completed the construction of rehabilitation exercise, and after preliminary test can effectively improve the swallowing function of PSD patients. On this basis, this study involved rehabilitation exercise in different stages of early rehabilitation of PSD patients, so as to systematize, standardize, simplify and visualize rehabilitation exercise. Finally, the optimal starting time of early rehabilitation therapy for PSD patients was determined, and the effects of starting rehabilitation training at different times were compared.

Aim

The main purpose of this study was to compare the recovery degree, prognosis and safety of swallowing function in PSD patients with early rehabilitation measures at different times, so as to provide a basis for exploring the best time of early swallowing function rehabilitation in PSD patients.

Study Design And Setting

Our study was a prospective, multicenter, subject and evaluator blind, practical randomized controlled trial. Study subjects will be recruited, treated and evaluated at three medical facilities. Informed consent will be obtained when screening is appropriate, followed by baseline assessment prior to randomization. Randomly generated sequences were assigned to a control group and three experimental groups in a ratio of 1:1:1:1. After randomization, the experimental group will start 4-week of continuous care regimen (neuromuscular electrical stimulation therapy and rehabilitation exercise) at different times, while the control group will only receive routine rehabilitation (neuromuscular electrical stimulation therapy). All four groups will be offered other conventional ischemic stroke treatments. The main outcome was to compare the recovery of swallowing function and efficacy of the four groups after the completion of 4-week rehabilitation training. Our protocol presentation is in accordance with the Standard Protocol Items: Recommendations for Interventional Trials 2013 (SPIRIT 2013) Guidelines ^[31]. The study flow-chart is presented as Fig. 1. The study enrollment, intervention, and evaluation schedule is show as Table 1.

Participants

The inclusion criteria are as follows: to be eligible, subjects must (1) Age 18 years or older; (2) It should comply with the Main Diagnostic Points of Various Cerebrovascular Diseases in China 2019 formulated by the Cerebrovascular Group of the Chinese Society of Neurology ^[32], and confirmed by CT or MRI examination; (3) Dysphagia was detected by the drinking water test and standard swallowing function score scale; (4) The time of admission was less than or equal to 3 days after onset; (5) The neurological Impairment Scale (National Institutes of Health Stroke Scale, NIHSS) was used to assess clear consciousness, no cognitive impairment, able to understand and execute simple instructions, and able to complete rehabilitation training; (6) After discharge, the patient lives alone and does not use smart phones; (7) Informed consent and voluntary participation in this study.

The exclusion criteria are as follows: (1) Progressive stroke; (2) Patients with thyroid disease and throat infection affecting local swallowing activities; (3) Patients with severe organ dysfunction, malignant tumor and other critical conditions; (4) Participate in other intervention researchers at the same time; (5) Withdrawal or loss of follow-up and incomplete participation in this study.

Table. 1 Participant timeline

Ethical Issues

Our protocol complies with the principles of the Declaration of Helsinki, and has been approved by the Ethics Committee of Lanzhou University Second Hospital. We also completed registration at Chictr.org.c (ChiCTR2000029149).

Recruitment Strategies And Informed Consent

First, all patients will be enrolled at the neurology inpatient units of three medical institutions to complete 4-week swallowing rehabilitation. The details of our study, including trial objectives, features, possible benefits and risks, other treatment options available, and the rights and obligations of subjects stated in the Declaration of Helsinki should then be made clear to patients by researchers with their grouping codes. After obtaining written informed consent, subjects will be enroll in the study. During the trial, if new ideas about research ethics emerge, the ERC will deal with written amendments to informed consent and, after approval, the individual's consent will be requested again. In the event that patients drop out; their available data will be retain for final analysis. We will strictly protect the personal information of research subjects and only use it for data analysis.

Randomization And Allocation Concealment

The sample size was allocated according to the proportion of monthly admission to the department of neurology of each hospital, and data were collected at the same time. In order to prevent contamination between the experimental group and the conventional group, the data of the control group were collected first, and the data of the experimental group were collected after all the patients in the control group were discharged. Subjects were randomly and equally assigned and recorded by computer-generated randomization grouping codes. Subjects were placed in sealed, opaque envelopes, which were opened upon admission and agreed to join the study to ensure secrecy of the assignment.

Double blindness was used. The evaluators and data analysts kept group assignments blind, patients were informed that they would begin rehabilitation intervention after assessment, baseline and post-intervention data were collected by two study investigators; Grouping is not recorded in the hospital's electronic medical record. In the last case, the blind was unblinded, and the sponsor, evaluator, implementer and data analyst were present to open the sealed envelope in order

Interventions

Control group

The control group will only receive clinical routine rehabilitation therapy -- neuromuscular electrical stimulation therapy on the basis of routine care for ischemic stroke, from the second day of admission to discharge, once a day, 20 minutes each time. Due to the rapid bed rotation, the average length of stay of PSD patients was about 7 days.

Experimental group

The experimental group was given rehabilitation exercise on the basis of the control group. According to the different times of starting rehabilitation exercise training after stroke onset, the experimental group was divided into 0–3 days group (group A), 4–7 days group (group B) and 8–14 days group (group C). Each group lasted for 4 weeks, once every morning and afternoon, about 30 minutes each time. One to one by the rehabilitation specialist nurses to teach patients and their families, and issued manuals, training videos and needed items (tongue depressors, whistles, molars), explain the purpose of rehabilitation exercises, significance and simple mechanism of action. Based on evidence-based medicine, the rehabilitation exercise was modified and perfected by Delphi method, and constructed to be suitable for PSD patients. The content mainly includes facial training, training the lips, tongue, throat, jaw movement training, the training well, Masake training method, Shaker training method, presented in the form of manuals, and with practice video, and music as the background, the stroke rehabilitation training swallowing visualization, visualization, simplification, details are shown in Table. 2.

Patients practice rehabilitation exercise for the first time, first open the rehabilitation exercise manual, teach rehabilitation exercise training action, after the basic understanding, in the ward of the TV broadcast rehabilitation exercise video, guide patients to follow the video training, for patients do not understand the place to explain, until patients understand the whole set of rehabilitation exercise. During rehabilitation training, caregivers of patients are required to participate in the training, because each patient is in a different state. When patients cannot complete certain movements themselves, caregivers can assist patients in training. In the rest of the training time, patients follow the video for training, caregivers for auxiliary training, if there is a problem with rehabilitation nurses for movement guidance.

Table 2

Post-Stroke Dysphagia rehabilitation exercise
Designation	Content	Methods
Ⅰ. Facial training	1.Cheek massage	Place your hands on both sides of your cheeks and massage clockwise for 4 beats and counterclockwise for 4 beats.
	2.TMJ massage	Place both hands on the bilateral TMJ and massage 4 beats clockwise and 4 beats counterclockwise for 4 consecutive 8 beats.
	3. Frown	Frown 4, relax 4, hold 2 8 beats.
	4. The gills	Drum gills 4 beats, air movement 2 beats left, air movement 2 beats right, lasting 4 eight-beats.
	5. Smile	Smile 4 beats, relax 4 beats, and continue for 4 octaves.
	6. Show	Grin on 4 beats, relax on 4 beats, and continue for 4 octaves.
	7. Open and close your mouth	Open mouth for 4 beats, close mouth for 4 beats. It lasts 4 octaves.
Ⅱ. Labial ministry training	1. Zipped lips pronounce "um"	Press your lips together and say "um" for 4 beats, relax for 4 beats. It lasts 4 octaves.
	2. Close your mouth and say "woo"	Press your lips together, say "woo" 4 beats, relax 4 beats. It lasts 4 octaves.
	3. "Yi" and "woo" conversion	Pronounce "yi" 2 beats, immediately pronounce "woo" 2 beats, relax 4 beats. It lasts 4 octaves.
	4. Keep your lips closed	Close your lips, press the 4, relax the 4. It lasts 4 octaves.
	5.Resistance training	Tongue depressor in the middle of lips, lips hold tongue depressor, forcibly close, pull out tongue depressor, and lips resistance 2 beat, relax 2 beat;With lip resistance 2 beats, relax 2 beats. It lasts 4 octaves.
		Tongue depressor on the right half of the lips, lips hold tongue depressor, forcibly close, pull out tongue depressor, and lips resistance 2 beat, relax 2 beat;With lip resistance 2 beats, relax 2 beats. It lasts 4 octaves.
		Tongue depressor on the left half of the lips, lips hold tongue depressor, forcibly close, pull out tongue depressor, and lips resistance 2 beat, relax 2 beat;With lip resistance 2 beats, relax 2 beats. It lasts 4 octaves.
	6.Whistle training	Whistle 4 beats, relax 4 beats. It lasts 4 octaves.
	7.To suck	Wrap your lips around the molar stick. It lasts 2 octaves.
Ⅲ. Tongue training	1.Slip the tongue	Extended tongue for 2 beats, contracted tongue for 2 beats. It lasts 4 octaves.
	2. Move your tongue up and down	The tongue touches the upper lip for 4 beats, and the tongue touches the lower lip for 4 beats. It lasts 4 octaves.
	3.Move your tongue from side to side	The tongue touches the left corner of the mouth 4 beats, and the tongue touches the right corner of the mouth 4 beats. It lasts 4 octaves.
	4.Tongue on top of palate	Tongue top palate 4 beats, relax 4 beats. It lasts 4 octaves.
	5.Licking your lips with the tip of your tongue	Lick your lips with the tip of your tongue 1 time, 8 beats. It lasts 4 octaves.
	6. Pronounce "T, D"	Pronounce "t" 2 beats, relax 2 beats; pronounce "d" 2 beats, relax 2 beats. It lasts 4 octaves.
	7. Pronounce "CH" and "C"	Pronounce "CH" 2 beats, relax 2 beats; Pronounce "C" 2 beats, relax 2 beats. It lasts 4 octaves.
	9. Pronounce the "K, G" sound	Pronounce "K" 2 beats, relax 2 beats; Pronounce "G" 2 beats, relax 2 beats; It lasts 4 octaves.
Ⅳ.Pharyngeal training	1. Hold your breath and sound training	The patient sat on the chair, supported the chair face with both hands and did pushing and pressing action 2 beats at the same time, held his breath, kept the upper body upright, closed the glottis 2 beats, suddenly opened the glottis, exhaled "ah" 2 beats, relaxed 2 beats. It lasts 2 octaves.
	2. Subglottic swallowing exercises	The patient placed his finger on the upper edge of the thyroid cartilage, took a deep breath in the nasal cavity for 2 beats, held his breath for an empty swallowing, and felt the thyroid cartilage move upward for 4 beats. Immediately after swallowing, he coughed for 2 beats. It lasts 2 octaves.
	3. Pronunciation training	Open mouth pronounce "ah" 4 beats, relax 4 beats;The tongue tip on top of the palate pronounce "yi" 4 beats, relax 4 beats. It lasts 2 octaves.
Ⅴ. Mandibular exercise training	1.Teething stick training	Place the molar stick between the patient's incisors, and let the patient bite. It lasts 2 octaves.
	2.Move your jaw from side to side	The jaw moves 2 beats to the left and 2 beats to the right. It lasts 4 octaves.
	3.Tap your teeth up and down	Tap teeth up and down for 2 consecutive eight beats.
VI.Respiratory muscle training	1.Abdominal breathing	Inhale for 2 beats, hold for 2 beats, exhale for 2 beats, and relax for 2 beats. It lasts 4 octaves. (Abdominal breathing take supine or comfortable meditative sitting position, relax the whole body, the right hand on the belly button, the left hand on the chest.As you inhale, expand your abdomen outward as much as possible, keeping your chest still.As you exhale, pull your stomach in as much as possible, keeping your chest still.)
VI.Respiratory muscle training	2.Lip constriction	Inhale for 2 beats, hold for 2 beats, and exhale for 4 beats. It lasts 4 octaves. (Breathe in through your nose and exhale with your lips closed. Hold the exhale for as long as possible.)
Ⅶ. Masake training method		Place the tip of your tongue between your teeth for 2 beats, empty swallow for 4 beats, relax for 2 beats. It lasts 4 octaves. (When swallowing, the tongue tip later between the teeth of a small part of the tongue or pull out a small part of the tongue by hand, and then the patient to swallow, so that the throat wall forward movement and tongue root close to increase the pressure of the pharynx.)
Ⅷ. Shaker training		Let the patient lie supine on the bed, raise the head to watch the toe 2 beats (note that the shoulder should not leave the bed surface), relax 2 beats. It lasts 4 octaves. (Have the patient lie on the bed on their back with their head as high as possible, but their shoulders should not leave the bed surface, and their eyes should be on their toes.)

Outcome Measures

Primary outcome measures

Degree of improvement in swallowing function: Swallowing function was assessed on the day of enrollment and the day of the end of the intervention. The Standard Swallowing Function Assessment Scale (SSA) was used, with a score ranging from 18 to 46, and the higher the score, the worse the patient's current swallowing function.

Efficacy assessment: Swallowing function was evaluated on the day of enrollment and the end of intervention. The Water Swallow Test (WST) of the patient was grade 1, and the swallowing disorder basically disappeared Using the WST rating, the patient was WST grade 1, and the swallowing disorder basically disappeared and was considered to be cured. The WST of patients increased by 2 grade or more, and the swallowing function improved significantly. The WST of the patient increased by 1 grade and the swallowing function improved. Patients with no significant changes in WST and swallowing function were considered ineffective. Effective rate = (cured + effective + effective) cases/total cases ×100%.

Secondary Outcome Measures

(1) Incidence of choking: During the intervention, the patient's family members recorded The Times of choking reaction during autonomous feeding or nasal feeding at any time, and The Times of choking for each patient/the total times of choking for all patients in the group multiplied by 100%.

(2) Incidence of pneumonia: Patients diagnosed with pneumonia were recorded by their competent doctors during the intervention. New or progressive pulmonary infiltrate appeared after stroke, with 2 or more clinical symptoms of infection: the patient's body temperature was greater than or equal to 38℃; Lung imaging (X - ray or CT) suggests recent inflammatory lesions or lung texture changes; New respiratory catarrh symptoms, cough, expectoration or aggravation of the original respiratory symptoms, purulent sputum or sputum volume increased significantly, with or without chest pain; New wet rales or changes in respiratory sounds were detected in the lungs. The total number of white blood cells is greater than or equal to 10×10⁹/L, and there is a history of aspiration, it is caused by food, oral and pharyngeal secretions, stomach contents and other irritant substances into the lower respiratory tract pneumonia.

(3) Quality of life: Assessment was performed at enrollment and on the day of the end of the intervention. The Swallowing Disorders Specific Quality of Life Scale (SWAL-QOL) included 11 items, which were divided into 44 related items. Each item included 5 grades, with a score ranging from 1 to 5. The higher the score, the higher the patient's quality of life was.

(4) Compliance rate: the number of rehabilitation exercises completed by patients or their family members during the intervention process is recorded, and the number of training completed by patients/the total number of rehabilitation exercises training multiplied by 100%.

Follow-up

Due to the limitations of clinical practice, PSD patients generally stay in hospital for 1 week, and then practice at home for another 3 weeks. Follow-up was conducted after the 4-week intervention period. The degree of recovery of swallowing function and quality of life of the patients were evaluated by video, and the patients or their caregivers were asked to collect the required information and give feedback in the form of photos.

Data Management And Quality Control

(1) The research group of director of nursing Department of Lanzhou University Second Hospital is responsible for the data management of the project. Data supervision is completed by the director's research group of the Nursing Department of Lanzhou University Second Hospital, which is independent of the sponsor and has no conflict of interest. If any content is not included in this plan, it shall be decided by the sponsor, evaluator and data supervisor through consultation. Interim results are available to the data analyst, final results are available at the end of the study, and the sponsor may terminate the study. At the stage of project design, experts in medical statistics, neurology and rehabilitation medicine will guide and determine the final research scheme.

(2) Intervention and data collection stage: subjects were selected strictly according to the inclusion criteria; Data will be obtained from medical records, direct interviews with patients or their caregivers. All rehabilitation nurses received centralized and unified training before the implementation of the study, to help them get familiar with and master the content of rehabilitation exercises, and to ensure the homogenization of operation modes of different personnel; The intervention time of each subject should be as consistent as possible and the intervention environment should be the same. During home training after discharge, patients were provided with daily feedback of training photos, and patients who failed to complete training without reason were provided with video supervision. Three graduate students to ensure the homogeneity of data collection methods completed data collection.

(3) Data entry and analysis stage: During data entry, two researchers input data separately for proofreading. After the input, 10% of the data will be randomly select for verification. If the check rate is greater than 90%, it is qualified.

(4) The audit team, independent of the investigator and sponsor, reviews the progress and materials of the study every three months.

Sample size considerations

We assumed a two-tailed comparison and set the type I error rate at 0.05 with 90% power. Based on previous studies ^{[33, 34]} of rehabilitation training for swallowing after stroke, we plan to screen approximately 180 patients with PSD. After screening, subjects were randomly divided into three experimental groups and a control group. For a conservative estimate (dropout rate = 10%), we assume that 164 subjects will complete the study. In order to reduce the lost follow-up rate, we will use regular communication via phone or social media to keep participants engaged.

Statistical analysis

In this study, Excel2010 was used for data entry, SPSS25.0 statistical software package was used for analysis, measurement data were expressed by Analysis of variance(ANOVA) for single-factor analysis, multivariate linear regression analysis for multi-factor analysis. Multiple fillings if missing data exists. Χ² test was used for univariate analysis and Logistic regression was used for multivariate analysis. P < 0.05 was considered as statistically significant difference. SSA score, WST score and SWAL-QOL score were completed at enrollment and at 4 weeks of intervention, and assessments at different time points were analyzed by repeated measures of ANOVA. Adverse events in each group will be recorded as the percentage (%) that was assessed for safety using the Chi-square test or Fisher's exact test..

It is estimated that the incidence of cerebrovascular diseases in China will increase by about 50% in 2030 compared with 2010 ^[35]. Deglutition disorder is caused by the injury of glossopharyngeal nerve and vagus nerve caused by cerebral apoplexy. Swallowing consists of four main stages: oral preparation, oral, pharyngeal and esophageal. Stroke typically affects the first three stages, mainly by interrupting chewing and moving food in the mouth or delaying the pharyngeal reflex. Many regions of the brain, especially the brainstem, thalamus, basal ganglia, cerebellum and motor and sensory cortex, are involved in the control of spontaneous and unconscious swallowing ^{[36, 37]}. Diseases or lesions in these regions may lead to abnormal lip closure, delayed or non-triggered swallowing reflex, and dysfunction of the swallowing oropharyngeal stage. This is manifested by incomplete oral cleaning, hydrocephalus, nausea and aspiration of food or secretions ^[38–40]. However, because the early rehabilitation measures in some neurology wards are relatively single and the bed turnover rate is relatively fast, most PSD patients still have no significant improvement of swallowing disorders when discharged. Therefore, the application of early rehabilitation nursing intervention in clinical treatment is very necessary and important for PSD patients.

Early rehabilitation nursing belongs to multi-project rehabilitation training, through the functional training of lips, tongue muscles, etc., continuously input stimulus information to brain cells, extend motor nerve synapses, and form a new conduction pathway with the normal neurite around, in order to restore brain cell function and feedback pathway. The rehabilitation exercise used in this study is based on evidence-based medical evidence construction, modified and improved by Delphi method, so as to make it more suitable for the practice of PSD patients. In addition, it can also provide rehabilitation guidance for PSD patients in hospitals, communities, families, etc., provide targeted continuity of care services for PSD patients, ensure the continuity of care services, thus reducing the number of patients hospitalized again, reduce the cost of rehabilitation treatment, and effectively reduce the economic burden of patients. It can improve the quality of life of PSD patients, and the nursing staff can establish a good nurse-patient relationship with the patient's family members by guiding the process of patient rehabilitation, and improve the satisfaction, which is worthy of being widely promoted in clinical nursing.

Epidemiological and statistical data showed that the incidence of dysphagia within 3 days of stroke onset was as high as 51% ^[41]. PSD patients in the acute stage mainly take drug therapy and pay little attention to functional recovery. However, the neglect of rehabilitation treatment of acute cerebral infarction is one of the important reasons for the high disability rate of cerebral infarction recognized by the medical community. Studies have suggested that the earlier rehabilitation after stroke is started, the better the effect ^[42]. However, this review did not provide a clear description of the time to start rehabilitation after stroke. There are also guidelines that clearly indicate that stroke patients should be involved in rehabilitation treatment as soon as possible after their condition is stable (with stable vital signs and no further progress of symptoms and signs) ^[14]. In 2014, the AHA/ASA recommendations for post-stroke rehabilitation ^[43] stated that it is currently agreed that activity should be started as early as possible after stroke, but there is still controversy over the exact start time. Therefore, we designed this study. Both the experimental group and the control group received basic nursing and rehabilitation measures. The experimental group started early rehabilitation at different times and was divided into three groups with the same duration of intervention. The limitations of this study are as follows: (1) There may be deviations in operation when patients are recruited from three medical institutions. Therefore we will implement strict training and supervision to ensure the uniformity and consistency of operation as far as possible. (2) These three hospitals are located in the same city, so their representativeness may be relatively poor. (3) Follow up after the completion of the 4-week rehabilitation intervention, since patients spend half of their time in hospital and half at home, which means that compliance of participants may be an issue. Therefore, we have designed rehabilitation training completion forms and regular telephone tracking to minimize this situation.

Trial Status

At the time of submission ethics approval has been granted. The study started recruiting patients in June 2021. Recruitment of the study is still ongoing and, so far, 60 patients have been recruited for this trial. We anticipate that 12 months will be needed to complete the trial.

PSD: Post-stroke dysphagia; SSA: Standard Swallowing Function Assessment Scale; WST: Water Swallow Test; SWAL-QOL: Swallowing Disorders Specific Quality of Life Scale; ANOVA: Analysis of variance; SPIRIT 2013: Standard Protocol Items: Recommendations for Interventional Trials 2013.

Acknowledgements

The authors would like to thank Yuxing Wang and Xiayu Xiao, Department of Geriatrics, Gansu Hospital of Traditional Chinese Medicine, and Jia Wu, Department of Neurology, First Hospital of Lanzhou University, for their help in collecting clinical data.

Protocol version

Version 1.0. Complete the protocol content by 2021.5.7.

Funding

Cuiying Science and Technology Innovation Project of the Second Hospital of Lanzhou University in 2020; No. CY2020-MS19

Availability of data and material

The trial plan and data can be obtained through the trial registration website. All de-identified data will be available after articles related to the data are published. A substantial contributor to the design, implementation and reporting of clinical trials will be qualified as an author of the final trial report.

Authors' contributions

HY conceived the research scheme and completed the research design. Manuscript drafted by HY, YHD, XLW. QX, JPZ and YPW have revised their papers, drawing tables and figures. HXW polished the final draft. Dr. XMD provided professional design advice. All the authors read the final manuscript.

Ethics approval and consent to participate

This study has been approved by the Ethics Committee of the Second Affiliated Hospital of Lanzhou University (Ref. : 2021A-194) and is being randomized Consent for publication.

Biological specimens

No biological specimens were collected as part of this trial.

Competing interests

The author claims no competing interests. The sponsor is responsible for promoting the study and has the final say on the study design.

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Clinical Effects Of Early Rehabilitation Training At Different Time In Patients With Dysphagia After Stroke: Study Protocol For A Multicenter Randomized Controlled Trial

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Abstract

Figures

Background

Methods/design

Aim

Study Design And Setting

Participants

Ethical Issues

Recruitment Strategies And Informed Consent

Randomization And Allocation Concealment

Interventions

Control group

Experimental group

Outcome Measures

Primary outcome measures

Secondary Outcome Measures

Follow-up

Data Management And Quality Control

Statistical analysis

Discussion

Trial Status

Abbreviations

Declarations

References

Supplementary Files

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