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

December 27, 2023 updated by: Zhang liqiong

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230032
        • Zhangliqiong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: control group
Provide participants with routine rehabilitation treatment
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.
Other: observation group
Participants received EDP treatment on the basis of conventional rehabilitation treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity(FVC)
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
Forced Expiratory Volume in 1 second (FEV1)
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
Forced expiratory volume in 1 second as a percentage of forced vital capacity(FEV1/FVC)
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
diaphragmatic excursion of deep breath(DE-DB）
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
Thickening Fraction(TF)
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
diaphragmatic excursion of quiet breath(ED-QB)
Time Frame: 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).
Day 1 (before starting treatment) and 4 weeks later
the Modified Trunk Impairment Scale (mTIS)
Time Frame: 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.
Day 1 (before starting treatment) and 4 weeks later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhang liqiong

Investigators

  • Study Chair: Liqiong Zhang, Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

August 14, 2023

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

December 13, 2023

First Submitted That Met QC Criteria

December 27, 2023

First Posted (Actual)

January 10, 2024

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

December 27, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zliqiong

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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