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.
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
- Recruiting
Yinkai Cheng
Yiwu, Zhejiang, 310000
Yinkai Cheng, 15067757337, 505184583@qq.com
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:
- Does myoelectric biofeedback therapy promote the restoration of upper limb function in elderly patients with cerebral infarction?
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- Conditions
- Biofeedback, Rehabilitation, Cerebral Infarction
- 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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Observation Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted5 Jun 2024
- Study start1 Jul 2024
- Primary completion1 Jun 2025 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BiofeedbackStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinkai Cheng, Study chair, The Fourth Affiliated Hospital Zhejiang University School of Medicine
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06443008
- Acronym / sponsor ID
- KY-2024-099
- Conditions
- Biofeedback, Rehabilitation, Cerebral Infarction
- Keywords
- Rehabilitation treatment, upper extremity motor function, emg biofeedback, cerebral infarction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does myoelectric biofeedback therapy promote the restoration of upper limb function in elderly patients with cerebral infarction?
- What medical problems do participants have with myoelectric biofeedback therapy?
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
- 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.
- 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.
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –Comprehensive rehabilitation treatment in control group |
| Observation Group | Experimental | Device: Observation GroupThe observation group carried out myoelectric biofeedback therapy on the basis of the control group |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation GroupOn 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. | Device | Observation Group |
Primary outcome
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
Fugl-Meyer Functional Score (FMA) is evaluated, and the higher the score, the stronger the motor function.
1 secondary outcome
Influence on stroke quality of life in elderly patients with cerebral infarction
Time frame: Within 3 days of hospitalization, on the 1 day of discharge, one month after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Biofeedback
Recruiting
Trial to Evaluate Fecobionics in Fecal Incontinence (FI) (NORMAL and ABNORMAL-FI)
Normal Subjects, Fecal Incontinence
Recruiting
A Comparison of Heart Rate Variability Biofeedback, Mindfulness, and Psychoeducation-based Interventions on Clinical Recovery Outcomes in Patients Undergoing Total Knee Arthroplasty
Pain (Knee), Pain and Anxiety
Recruiting
Feasibility and Preliminary Effects of a Therapeutic Approach Using Ultrasound Visual Biofeedback in Children With AFI: a Pilot Randomized Clinical Trial.
Childhood Apraxia of Speech, Speech Sound Disorders
Not yet recruiting
Personalized Weight-Bearing With Smart Crutch Tips After Surgery for Tibial Plateau Fractures
Tibial Plateau Fracture
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yinkai Cheng study chair
The Fourth Affiliated Hospital Zhejiang University School of Medicine
1 site in 1 country: see every site and its status.
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.