External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients

Stroke Clinical Trial

Official title:

External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT06198946
• Other study ID #: Zliqiong
• Status: Suspended
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: The First Affiliated Hospital of Anhui Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to observe the enhancement of trunk balance ability, pulmonary function, and diaphragm function in stroke patients after treatment of external diaphragm pacing（EDP）, and analyze the potential correlation between trunk balance ability and respiratory function metrics. The main questions it aims to answer are:

• What is the effect of EDP treatment on trunk balance and respiratory function in stroke patients?

• Is there a correlation between trunk balance ability and respiratory function?

Participants admitted to the Department of Rehabilitation Medicine at the First Affiliated Hospital of Anhui Medical University were randomly divided into an observation group and a control group：

• The control group received conventional rehabilitation therapy for 4 weeks.

• The observation group received EDP treatment in addition to conventional rehabilitation therapy for 4 weeks.

Description:

Objective：To observe the enhancement of trunk balance ability, pulmonary function, and diaphragm function in stroke patients after treatment of external diaphragm pacing（EDP）, and analyze the potential correlation between trunk balance ability and respiratory function metrics.

Methods：Thirty stroke patients admitted to the Department of Rehabilitation Medicine at the First Affiliated Hospital of Anhui Medical University from January 2023 to August 2023 were selected. They were randomly divided into an observation group (n=15) and a control group (n=15). The control group received conventional rehabilitation therapy, while the observation group received EDP treatment in addition to conventional rehabilitation therapy for 4 weeks. Independent sample t-tests and rank-sum tests were used to compare the Modified Trunk Impairment Scale (mTIS) scores, Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), FEV1/FVC change in percentage of Vital Capacity from sitting to supine position (ΔVC), diaphragmatic excursion of quiet breath(DE-QB), diaphragmatic excursion of deep breath (DE-DB), and Thickening Fraction (TF) between the two groups of patients. Pearson correlation analysis was employed to explore the correlations among these indicators.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 30
• Est. completion date: September 30, 2024
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients who meet the diagnostic criteria for stroke for the first time;

• Patients whose disease duration is within 6 months, have received specialist and standardized treatment, and have stable vital signs;

• Patients are informed of this study, voluntarily accept rehabilitation treatment, and sign an informed consent form;

• Patients who have no chronic breathing before and after stroke History of systemic and circulatory diseases.

• 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:

• Those who are complicated by severe heart, lung and other organ dysfunction diseases, such as pulmonary embolism, pacemaker placement, etc.;

• Those who are complicated by severe cognitive impairment and abnormal hearing and understanding;

• There are other reasons why electrical stimulation treatment is not suitable, Such as sudden unstable vital signs, malignant tumors, combined with mental illness, etc.

Related Conditions & MeSH terms

• Respiratory Function
• Stroke

Intervention

Device:
• External diaphragm pacing(EDP)
After the skin is disinfected, place the small electrode pads on the lower 1/3 of the outer edges 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. Adjust the pacing according to the patient's tolerance. Frequency and stimulation intensity, each treatment time is 20 minutes, treatment is once a day, 5 days a week, and the treatment course is 4 weeks.

Other:
• Routine rehabilitation treatment
Participants received comprehensive rehabilitation treatments such as muscle strength training, hemiplegic limb comprehensive training, balance function training, limb neuromuscular electrical stimulation, acupuncture and other comprehensive rehabilitation treatments. Each project was 30 minutes/time, once a day, 5 days a week, and the treatment course was 4 weeks.comprehensive rehabilitation treatments, each item is 30 minutes/time, once a day, 5 days a week, and the treatment course is 4 weeks.

Locations

Country	Name	City	State
China	Zhangliqiong	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Zhang liqiong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Vital Capacity(FVC)	It is used to assess Respiratory function.FVC was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).	Day 1 (before starting treatment) and 4 weeks later
Primary	Forced Expiratory Volume in 1 second (FEV1)	It is used to assess Respiratory function.FEV1 was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).	Day 1 (before starting treatment) and 4 weeks later
Primary	Forced expiratory volume in 1 second as a percentage of forced vital capacity(FEV1/FVC)	It is used to assess Respiratory function.FEV1/FVC(%) was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).	Day 1 (before starting treatment) and 4 weeks later
Primary	diaphragmatic excursion of deep breath(DE-DB)	It is used to assess Respiratory function.DE-DB was evaluated using Sonoson portable color ultrasound (M-Turbo).	Day 1 (before starting treatment) and 4 weeks later
Primary	Thickening Fraction(TF)	It is used to assess Respiratory function.TF was evaluated using Sonoson portable color ultrasound (M-Turbo).	Day 1 (before starting treatment) and 4 weeks later
Primary	diaphragmatic excursion of quiet breath(ED-QB)	It is used to assess Respiratory function.DE-QB was evaluated using Sonoson portable color ultrasound (M-Turbo).	Day 1 (before starting treatment) and 4 weeks later
Primary	the Modified Trunk Impairment Scale (mTIS)	It is used to assess trunk balance ability and includes the dynamic seated balance subscale (10 points) and the coordination subscale (6 points), with a total score of 16 points.	Day 1 (before starting treatment) and 4 weeks later