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BiofeedbackNCT06443008

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

A study testing Observation Group in people with Biofeedback and Rehabilitation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Biofeedback, Rehabilitation, Cerebral Infarction
What is being tested?
Observation Group
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
1 Jul 2024to 1 Jun 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • Subject's poor compliance
  • Subjects with skin allergies
  • Those who do not meet the criteria for diagnosis and inclusion;
  • 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;

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Yinkai Cheng

    Yiwu, Zhejiang, 310000

    Yinkai Cheng, 15067757337, 505184583@qq.com

    Recruiting

Other trials in China

About this study

Official title: Objective To Investigate the Effect of Myoelectric Biofeedback Therapy Combined With Comprehensive Rehabilitation Training on Upper Extremity Motor Function in Elderly Patients With Hemiplegia With Cerebral Infarction

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.

Being tested
Observation Group
Keywords
Rehabilitation treatment, upper extremity motor function, emg biofeedback, cerebral infarction
Medical subject headings
Cerebral Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Observation GroupDevice

    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.

Study groups in NCT06443008
Study groupRoleWhat they receive
control groupNo interventionComprehensive rehabilitation treatment in control group
Observation GroupExperimentalThe observation group carried out myoelectric biofeedback therapy on the basis of the control group
Receives: Device: Observation Group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (1)
  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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion1 Jun 2025 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06443008
Sponsor's protocol ID
KY-2024-099
Status last verified
Feb 2025
First submitted
28 May 2024
Last updated
17 Feb 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Observation Group in people with Biofeedback and Rehabilitation, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yinkai Cheng (+86-15067757337, 505184583@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of myoelectric biofeedback therapy on upper limb function in elderly patients with cerebral infarction (time frame: Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.

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