Stroke Clinical Trial
Official title:
External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
Verified date | December 2023 |
Source | The First Affiliated Hospital of Anhui Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Zhangliqiong | Hefei | Anhui |
Lead Sponsor | Collaborator |
---|---|
Zhang liqiong |
China,
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 |
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