Ignite Creation Date:
2024-05-06 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06198946
Status:
SUSPENDED
Last Update Posted:
2024-01-10
First Post:
2023-12-13
Brief Title:
External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
Sponsor:
Zhang liqiong
Organization:
The First Affiliated Hospital of Anhui Medical University
Study Overview
Official Title:
External Diaphragm Pacing Therapy and Correlation Analysis of Trunk Balance and Respiratory Function in Stroke Patients
Status:
SUSPENDED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The first phase of the research has been completed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 pacingEDP 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
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:
ObjectiveTo observe the enhancement of trunk balance ability pulmonary function and diaphragm function in stroke patients after treatment of external diaphragm pacingEDP and analyze the potential correlation between trunk balance ability and respiratory function metrics
MethodsThirty 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 n15 and a control group n15 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 FEV1FVC change in percentage of Vital Capacity from sitting to supine position ΔVC diaphragmatic excursion of quiet breathDE-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
MethodsThirty 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 n15 and a control group n15 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 FEV1FVC change in percentage of Vital Capacity from sitting to supine position ΔVC diaphragmatic excursion of quiet breathDE-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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None