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

NCT06198946 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-10

No results posted yet for this study

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. 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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Zhang liqiong

    lead OTHER

Principal Investigators

  • Liqiong Zhang · Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2023-08-14
Completion
2024-09-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06198946 on ClinicalTrials.gov