External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
Phase: NA
Conditions: Stroke, Respiratory Function
Sponsor: Zhang liqiong

 
Research Proposal 
(Version number: 1.0; Version date: 2022.09.03) 
 
 
Project Name: External diaphragm pacing therapy and correlation study 
on trunk balance and respiratory function in stroke patients                            
Organization: The First Affiliated Hospital of Anhui Medical University                  
Department: Department of Rehabilitation Medicine                              
Researchers: ZHANG liqiong                                                
 
 

1.Integrity statement 
This study ensures that the operation is strictly in accordance with the test 
procedures and the authenticity of the data records; there is no conflict of 
interest in this study. 
 
2. Research topic 
External diaphragm pacing therapy and correlation study on trunk balance 
and respiratory function in stroke patients 
 
3. Research background: 
Stroke is a common neurological disease in clinical practice and is the leading 
cause of death and disability worldwide. Post-stroke patients are often left 
with multiple functional impairments. Although most people return to walking 
independently 6 months after stroke, balance and trunk control problems 
persist in the chronic stage of the disease, which has a significant impact on 
patients' quality of life. Impact. Post-stroke patients not only have functional 
impairments in limb movement and balance, but their respiratory function is 
also significantly lower than that of normal people. Clinical studies report that 
respiratory muscle training can not only improve respiratory function, but also 
promote the recovery of the body's balance function and trunk control ability. 
Some studies have pointed out that human trunk control also involves 
interaction with key respiratory muscles. When the activation of respiratory 
muscles is damaged, core stability decreases, affecting normal trunk balance. 
However, the correlation between trunk balance ability and respiratory 
function in stroke patients has not yet been clarified, which may provide new 
ideas for clinical rehabilitation evaluation and treatment of stroke patients. 
There are many clinical methods to evaluate the respiratory function of stroke 
patients. The commonly used quantitative evaluation methods are pulmonary 
ventilation function assessment and diaphragm ultrasound imaging. The 
diaphragm is the main respiratory muscle of the human body. Extracorporeal 
diaphragm pacing ( EDP ) therapy applies neuromuscular electrical 
stimulation of appropriate intensity and frequency to the phrenic nerve, which 
can improve the patient's respiratory movement by affecting the passive 
activity of the diaphragm and is beneficial to the treatment. Respiratory 
muscle weakness has significant effects. At present, clinical studies mostly 
use EDP for pulmonary function rehabilitation in patients with central nervous 
system diseases. It is believed that it can enhance the strength of respiratory 
muscles and improve patients' breathing exercises and quality of life. Studies 
have pointed out that EDP can not only improve the respiratory function of 
stroke patients, but also enhance trunk control ability. However, such reports 
are rare and limited to clinical observations. There are few studies on EDP's 
promotion of trunk balance function recovery and its specific mechanism of 
action. Based on this, the purpose of this study is to apply EDP to treat stroke 
patients, observe the improvement of trunk balance ability, lung function and 

diaphragm function in stroke patients, and analyze the correlation between 
trunk balance ability and respiratory function indicators. 
 
4. Research purpose 
Apply EDP to treat stroke patients, observe the improvement of trunk balance 
ability, lung function and diaphragm function in stroke patients, and analyze 
the correlation between trunk balance ability and respiratory function 
indicators. 
 
 
5. Design plan 
 
 
 
6. Research matters execution process 
2023.01.01 to 2023.08.01 , and relevant data before and after the intervention 
will be entered and sorted. Continue to review relevant domestic and foreign 
literature related to this topic and make a summary. 
2023.08.02-2023.09.30 The first stage of data analysis, discussion of results, 
and writing of the paper. 
2023.09. 3 0-2024.09.30 Continue to recruit subjects , conduct second-stage 
data analysis, discuss results, and write papers . 
 
7. Recruitment of participants 
30 stroke patients admitted to the Department of Rehabilitation Medicine of 
the First Affiliated Hospital of Anhui Medical University from January 2023 to 
August 2023 were randomly selected in the first phase . 
 
8. Ethical considerations 

This study has been approved by the Ethics Committee of the First Affiliated 
Hospital of Anhui Medical University. In accordance with the ethical principles 
of the "Ethical Review Methods for Biomedical Research Involving Humans", 
WMA's "Declaration of Helsinki" and CIOMS's "International Ethical 
Guidelines for Biomedical Research Involving Humans", after review and 
approval by the chief review committee, the review results will be reported to 
the ethics committee. Agree It carried out this research and published the 
research results publicly. Approval time is September 20, 2023, approval 
number: PJ2023-11-49. 
 
9. Inclusion and exclusion criteria 
Inclusion criteria: ①Patients who meet the diagnostic criteria for stroke for the 
first time; ②Patients whose disease duration is within 6 months, have 
received specialist and standardized treatment, and have stable vital signs; 
③are informed of this study, voluntarily accept rehabilitation treatment, and 
sign an informed consent form; ④no chronic breathing before and after 
stroke History of systemic and circulatory diseases. ⑤ The patient can 
maintain the starting posture evaluated by the mTIS scale for 10 seconds. 
The standard for the starting posture is: sitting on the edge of the bed without 
any support for the back and arms, with the thighs in full contact with the bed 
surface, and with the feet flat and the same width as the hips. On the ground, 
bend your knees 90° and place your arms on your thighs. 
Exclusion criteria: ① People with severe heart, lung and other organ function 
diseases, such as pulmonary embolism, pacemaker placement, etc.; ② 
People with severe cognitive impairment and abnormal hearing and 
understanding; ③ People who are not suitable for electrical stimulation 
treatment Other reasons include sudden instability of vital signs, malignant 
tumors, combined mental illness, etc. 
 
10. Grouping method 
Eligible patients were recruited by members of the project team and divided 
into experimental groups and control groups through a random number table 
method . Subjects were randomly enrolled and were unaware of their 
grouping , and only some researchers were informed of the grouping . 
 
1 1. Intervention methods 
The control group received routine rehabilitation training: with the help of 
rehabilitation therapists, corresponding muscle strength training, 
comprehensive training of hemiplegic limbs, balance function training, limb 
neuromuscular electrical stimulation, acupuncture and other comprehensive 
rehabilitation treatments were carried out according to the patient's functional 
injury site. On this basis, the observation group added an EDP-D2 external 
diaphragm pacemaker (Zhongke Tyco (Guangzhou) Electronic Technology 
Co., Ltd.) for treatment. The specific operation steps are as follows: After 

disinfecting the skin, place the small electrode pads on the lower 1/3 of the 
outer edge of the sternocleidomastoid muscles on the left and right sides, and 
place the large electrodes on the surface of the pectoralis major muscles on 
both sides, and fix them with medical tape. The pacing frequency and 
stimulation intensity are adjusted by the degree of stimulation. Each treatment 
time is 20 minutes, once a day, 5 days a week, and the treatment course is 4 
weeks. 
 
 
12. Measurement indicators 
(1) Pulmonary function measurement: Use an exercise cardiopulmonary 
testing system (Nanjing Hanya Smax58ce) to test the patient's lung function 
before treatment and 4 weeks after treatment, including forced vital capacity 
(FVC ), forced expiration in 1 second Forced Expiratory Volume in 1 second 
(FEV1), FEV1/FVC (%), standing and supine vital capacity (Position vital 
capacity, VC ), and calculate the change percentage of vital capacity from 
standing to supine position [ΔVC (%) : (upright vital capacity - supine vital 
capacity) / supine vital capacity (%)]. 
(2) Diaphragm function evaluation: The American Sonosonic portable color 
ultrasound (M-Turbo) was used to measure the diaphragmatic excursion of 
quiet breath (DE-QB) on the hemiplegic side of the two groups of patients 
before treatment and 4 weeks after treatment. and forced breathing 
diaphragm mobility (Diaphragmatic excursion of deep breath, DE-DB), and 
measure the thickness of the hemiplegic side diaphragm (The thickening of 
the diaphragm, Tdi) at the end of expiration and end of inhalation to calculate 
the diaphragm thickening rate [Thickening fraction, TF: (diaphragm thickness 
at end-inspiration - diaphragm thickness at end-expiration) / diaphragm 
thickness at end-expiration (%)]. 
(3) The Modified Trunk Impairment Scale to Norwegian Version ( mTIS ) is 
used to evaluate the patient's trunk balance ability before treatment and after 
4 weeks of treatment. 
 
1 3. Definition of effective identification of test participants 
Effective: The patient's intervention time is 4 weeks, and the patient's 
treatment is basically completed . The measurement indicators are completed 
according to standards and the data is complete . 
Withdrawal: Due to personal reasons, incompatibility with treatment, 
dissatisfaction with the research process or other reasons. 
Exclusion: Patients with severe comorbidities or complications who do not 
participate in the study. 
Loss to follow-up: The patient was suddenly discharged from hospital or 
transferred to another department during the trial, resulting in the continuation 
of the study. 

Confounding (confounding): A situation in which external factors or indicators 
have a false influence on the research results. 
Suspension: Refers to the premature termination of a study, which may be 
due to unpredictable safety issues, poor treatment efficacy, or other serious 
problems that have to stop the trial. 
Suspension: Suspension may occur due to safety issues, concerns about 
treatment efficacy, or other reasons that require further investigation. 
 
14. Statistical analysis methods 
All data were analyzed using spss26.0, count data were expressed as 
frequencies, and Fisher's exact probability method was used; for 
measurement data that conformed to normal distribution, the independent 
sample t test was used for comparison between groups, and Pearson 
correlation analysis was used for correlation; if it did not conform to normality 
Rank sum test was used for comparison of distribution between groups, and 
Spearman correlation analysis was used for correlation. P<0.05 was 
considered as a statistically significant difference. 
 
15. Expected results 
EDP therapy contributes to the restoration of respiratory function and trunk 
balance in stroke patients. Additionally,the trunk balance ability in stroke 
patients displays a correlation with Respiratory function.