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RecruitingNCT06443008Updated Feb 17, 2025

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

An interventional study of Observation Group in Biofeedback, Rehabilitation and Cerebral Infarction, sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine. Recruiting at 1 site in China. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-02-17.

Sponsored by The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

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

We divided the participants into control group and observation group using simple random method.We will number the numbers according to the order of inclusion: then from any row in the random number table as a starting point, we will get a random number sequentially from its series of numbers, paired with the included case number, and list the random distribution table.The control group was represented by odd numbers of random tables and even numbers by observation groups.The probability of being included in the control group and the observation group were 50% respectively.The control group underwent comprehensive rehabilitation training, and the observation group conducted myoelectric biofeedback treatment on the basis of the control group.

Control group treatment plan

  1. After stroke, medical staff should adjust the position of the patient every 2 hours, so that the patient's position is adjusted between the healthy side position and other positions, and provide the patient with soft pillow limit.
  2. Passive training, in the initial physical disability of the patient after treatment by the rehabilitation therapist to provide passive training for the patient, specifically by the rehabilitation therapist on the affected side joint.
  3. Anti-spasmodic activities, through the patient's activity training to avoid spastic symptoms, help the patient to change the posture to a healthy side position before the training begins.
  4. At the beginning of the training, the rehabilitation therapist places both hands under the patient's shoulder blades, so that the patient's shoulders and shoulder blades are stretched forward to help the patient stay seated.In addition, the patient is provided with Bobas handshake training to maintain the trunk forward tilt position during the training process, maintaining the center of gravity below, helping the patient to stay seated for a long time for balance training.
  5. Active training, the rehabilitation therapist instructs the patient to put the hand on the prepared cushion in advance, and then let the patient use both upper limbs to stretch the fixed elastic band to implement impedance training.After the above activities can be completed, you can try to implement refined operations, including threading and other activities that require high hand activities.After the patient's upper limb function has been restored, he or she can conduct autonomous life ability training under the guidance of a rehabilitation therapist, including basic activities such as getting up and washing.The pre-active training training time is maintained at about 0.5 h, and the maximum number of training times in one day is 3 times, and the intensity of training can be increased appropriately after the patient's physical condition has recovered.

Observation group treatment plan

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

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.

02

Conditions studied

  • Biofeedback
  • Rehabilitation
  • Cerebral Infarction

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Keywords

  • Rehabilitation treatment
  • upper extremity motor function
  • emg biofeedback
  • cerebral infarction
03

In context

Cerebral Infarction

219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.

This study's planned enrollment of 80 is below the median of 120 across 139 interventional studies indexed under Cerebral Infarction.

Browse Cerebral Infarction studies →

Lead sponsor

The Fourth Affiliated Hospital of Zhejiang University School of Medicine is the lead sponsor of 92 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Subject volunteered to participate in the experiment and signed
  2. Age ≥ 65 years old, no gender limit;
  3. Diagnosis of stroke patients;
  4. No other major cardiovascular diseases

Exclusion criteria

Exclusion Criteria:

  1. Subject's poor compliance
  2. Subjects with skin allergies
  3. Those who do not meet the criteria for diagnosis and inclusion;
  4. People with severe consciousness disorders, severe dementia, speech disorders, etc. who are unable to communicate and describe the disease;
  5. can not cooperate as required, poor compliance;
  6. participants in other clinical trials;
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • No intervention
    control group

    Comprehensive rehabilitation treatment in control group

  • Experimental
    Observation Group

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

    Device: Observation Group

Interventions

  • DeviceObservation Group

    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.

06

What researchers measure

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.

    Time frame: 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

    Assessment of Daily Living Ability Scale (ADL)is evaluated,The higher the score, the greater the independence of life.

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

07

Study locations

1 of 1 sites recruiting
  • Yinkai Cheng
    Yiwu, Zhejiang 310000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06443008
Lead sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Responsible party
Sponsor
First posted
Jun 5, 2024
Start date
Jul 1, 2024
Primary completion
Jun 1, 2025 (estimated)
Completion
Jun 1, 2025 (estimated)
Last update
Feb 17, 2025

Study contacts

Yinkai Cheng
Contact
505184583@qq.com
+86-15067757337
Yinkai Cheng
study chair · The Fourth Affiliated Hospital Zhejiang University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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