StrokeNCT06198946
External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
A study testing External diaphragm pacing（EDP） and Routine rehabilitation treatment in people with Stroke and Respiratory Function, run by Zhang liqiong at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Stroke, Respiratory Function
- What is being tested?
- External diaphragm pacing（EDP） and Routine rehabilitation treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read more
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.
Read the 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.
- Conditions
- Stroke, Respiratory Function
- Being tested
- External diaphragm pacing（EDP）, Routine rehabilitation treatment
- Keywords
- External diaphragm pacing, Respiratory function, Diaphragm function, Stroke
- Medical subject headings
- Stroke, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External diaphragm pacing（EDP）Device
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.
Routine rehabilitation treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| control group | Other | Provide participants with routine rehabilitation treatment Receives: Other: Routine rehabilitation treatment |
| observation group | Other | Participants received EDP treatment on the basis of conventional rehabilitation treatment Receives: Device: External diaphragm pacing（EDP）; Other: Routine rehabilitation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Vital Capacity(FVC)
It is used to assess Respiratory function.FVC was evaluated using an exercise cardiopulmonary testing system (Nanjing Hanya Smax58ce).
Measured: Day 1 (before starting treatment) and 4 weeks later
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).
Measured: Day 1 (before starting treatment) and 4 weeks later
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).
Measured: Day 1 (before starting treatment) and 4 weeks later
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).
Measured: Day 1 (before starting treatment) and 4 weeks later
Thickening Fraction(TF)
It is used to assess Respiratory function.TF was evaluated using Sonoson portable color ultrasound (M-Turbo).
Measured: Day 1 (before starting treatment) and 4 weeks later
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).
Measured: Day 1 (before starting treatment) and 4 weeks later
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.
Measured: Day 1 (before starting treatment) and 4 weeks later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start13 Feb 2023
- Primary completion14 Aug 2023
- Study completion30 Sep 2024 (estimated)
Why it stopped: The first phase of the research has been completed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang liqiong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang liqiong, The First Affiliated Hospital of Anhui Medical University
- Investigators
- Liqiong Zhang, Study chair, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06198946
- Sponsor's protocol ID
- Zliqiong
- Status last verified
- Dec 2023
- First submitted
- 13 Dec 2023
- Last updated
- 10 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
- ClinicalTrials.gov ID
- NCT06198946
- Acronym / sponsor ID
- Zliqiong
- Conditions
- Stroke, Respiratory Function
- Keywords
- External diaphragm pacing, Respiratory function, Diaphragm function, Stroke
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: The first phase of the research has been completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhang liqiongUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Other | Other: Routine rehabilitation treatmentProvide participants with routine rehabilitation treatment |
| observation group | Other | Device: External diaphragm pacing（EDP）, Other: Routine rehabilitation treatmentParticipants received EDP treatment on the basis of conventional rehabilitation treatment |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 .
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | observation group |
| Routine rehabilitation treatmentParticipants 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 | control group, observation group |
Primary outcome
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).
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).
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).
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).
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).
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liqiong Zhang study chair
Anhui Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing External diaphragm pacing（EDP） and Routine rehabilitation treatment in people with Stroke and Respiratory Function, run by Zhang liqiong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 10 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forced Vital Capacity(FVC) (time frame: Day 1 (before starting treatment) and 4 weeks later). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2024.