Effects of Myoelectric Biofeedback on Upper Limb Function in Post-stroke Patients

NCT06443008 | Recruiting

• 1 other identifier: KY-2024-099
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical trial is to investigate the effect of myoelectric biofeedback therapy on upper limb function in elderly patients with cerebral infarction, and to analyze the adjustment of stroke condition and quality of life.The main questions it aims to answer are:

1. 1.Does myoelectric biofeedback therapy promote the restoration of upper limb function in elderly patients with cerebral infarction?
2. 2.What medical problems do participants have with myoelectric biofeedback therapy?

Conditions

Biofeedback; Rehabilitation; Cerebral Infarction

Keywords

Rehabilitation treatment; upper extremity motor function; emg biofeedback; cerebral infarction

Outcome Measures

Primary Outcomes (1)

• Effect of myoelectric biofeedback therapy on upper limb function in elderly patients with cerebral infarction

  Fugl-Meyer Functional Score (FMA) is evaluated, and the higher the score, the stronger the motor function.

  Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge

Secondary Outcomes (1)

• Influence on stroke quality of life in elderly patients with cerebral infarction

  Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge

Study Arms (2)

control group

NO INTERVENTION

Comprehensive rehabilitation treatment in control group

Observation Group

EXPERIMENTAL

The observation group carried out myoelectric biofeedback therapy on the basis of the control group

Device: Observation Group

Interventions

Observation Group DEVICE

On the basis of myoelectric biofeedback treatment in the control group, the control group was trained alternately in each muscle group (triangle muscle, triceps brachii muscle group and forearm extensor muscle group). For example,After disinfection of the triangular, triceps and extensor muscles of the patient, the feedback electrode was attached to the area. The stimulation frequency was set at 50 Hz and the stimulation pulse width was set at 200 μs.During treatment, the patient is instructed to listen carefully to the device's password, drive the affected limb according to the specific password, and then perform tension and relaxation training.For each muscle group, the training time of each muscle group is about 0.5 h, 1 / d.In the later stage of treatment, the training intensity can be increased appropriately, so that the patient can carry out weight lifting during the feedback treatment, and listen to the password issued by the device to carry out muscle strength exercise.

Observation Group

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Subject volunteered to participate in the experiment and signed informed consent
• Age ≥ 65 years old, no gender limit;
• Diagnosis of stroke patients;
• No other major cardiovascular diseases

You may not qualify if:

• Subject's poor compliance
• Subjects with skin allergies
• People with severe consciousness disorders, severe dementia, speech disorders, etc. who are unable to communicate and describe the disease;
• can not cooperate as required, poor compliance;
• participants in other clinical trials;

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Yinkai Cheng

Yiwu, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Cerebral Infarction

Condition Hierarchy (Ancestors)

Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Vascular Diseases; Cardiovascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Yinkai Cheng

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Yinkai Cheng

CONTACT

+86-15067757337; 505184583@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 5, 2024
• Study Start: July 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)