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

Not Applicable

Suspended

• Conditions: Stroke; Respiratory Function
• Interventions: Other: Routine rehabilitation treatment; Device: External diaphragm pacing（EDP）

• Registration Number: NCT06198946
• Lead Sponsor: Zhang liqiong

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-02-13
• Primary Completion: 2023-08-14
• Status Verified: 2023-12
• Study First Submitted: 2023-12-13
• Study First Submitted QC: 2023-12-27
• Last Update Submitted: 2023-12-27
• Study First Posted: 2024-01-10
• Last Update Posted: 2024-01-10
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Routine rehabilitation treatment	Provide participants with routine rehabilitation treatment
observation group	Routine rehabilitation treatment	Participants received EDP treatment on the basis of conventional rehabilitation treatment
observation group	External diaphragm pacing（EDP）	Participants received EDP treatment on the basis of conventional rehabilitation treatment

Primary Outcome Measures

Name	Time	Method
Forced Vital Capacity(FVC)	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.FVC was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).
Forced Expiratory Volume in 1 second (FEV1)	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.FEV1 was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).
Forced expiratory volume in 1 second as a percentage of forced vital capacity(FEV1/FVC)	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.FEV1/FVC(%) was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).
diaphragmatic excursion of deep breath(DE-DB）	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.DE-DB was evaluated using Sonoson portable color ultrasound (M-Turbo).
Thickening Fraction(TF)	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.TF was evaluated using Sonoson portable color ultrasound (M-Turbo).
diaphragmatic excursion of quiet breath(ED-QB)	Day 1 (before starting treatment) and 4 weeks later	It is used to assess Respiratory function.DE-QB was evaluated using Sonoson portable color ultrasound (M-Turbo).
the Modified Trunk Impairment Scale (mTIS)	Day 1 (before starting treatment) and 4 weeks later	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.

Trial Locations

Locations (1)

Zhangliqiong; 🇨🇳 Hefei, Anhui, China