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The first phase of the research has been completed
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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group | Other | Provide participants with routine rehabilitation treatment |
|
| observation group | Other | Participants received EDP treatment on the basis of conventional rehabilitation treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Liqiong Zhang | Anhui Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhangliqiong | Hefei | Anhui | 230032 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2022 | Dec 27, 2023 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2022 | Dec 27, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Routine rehabilitation treatment | Other | 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. |
|
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |