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

NCT06198946 | Suspended

• 1 other identifier: Zliqiong
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 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

Stroke; Respiratory Function

Keywords

External diaphragm pacing; Respiratory function; Diaphragm function; Stroke

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Study Arms (2)

control group

OTHER

Provide participants with routine rehabilitation treatment

Other: Routine rehabilitation treatment

observation group

OTHER

Participants received EDP treatment on the basis of conventional rehabilitation treatment

Device: External diaphragm pacing（EDP）; Other: Routine rehabilitation treatment

Interventions

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.

observation group

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.

control group; observation group

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 .

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhang liqiong: lead

Study Sites (1)

Zhangliqiong

Hefei, Anhui, 230032, China

Location

MeSH Terms

Conditions

Stroke; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liqiong Zhang

  Anhui Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: resident physician

Study Record Dates

• First Submitted: December 13, 2023
• First Posted: January 10, 2024
• Study Start: February 13, 2023
• Primary Completion: August 14, 2023
• Study Completion: September 30, 2024
• Last Updated: January 10, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)