StrokeNCT07149129
Biofeedback After Stroke
A study testing Electromyographic Biofeedback in people with Stroke, run by Universidade Federal do Paraná at 1 site in Brazil.
Trial summary
Studies show that the use of electromyographic biofeedback combined with other therapies contributes to the reduction of upper limb spasticity after stroke. However, there is a lack of literature regarding the best protocols to use in clinical practice, as well as functional outcomes after this therapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stroke
- What is being tested?
- Electromyographic Biofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2025to Jun 2026
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a clinical diagnosis of stroke (imaging tests and a medical report)
- Spasticity with an Ashworth score equal to or less than 3 in the upper limb
- 20-60 years old
Who cannot join
- Other neurological impairments or trauma-orthopedic deformities in the upper limbs
- botulinum toxin/phenol injections within the previous 5 months
- medications that reduce muscle tone
- aphasia that prevents basic communication
- low vision or low visual acuity that prevents them from viewing the screen.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Use of Electromyographic Biofeedback in Upper Limb Rehabilitation After Stroke
Studies show that the use of electromyographic biofeedback combined with other therapies contributes to the reduction of upper limb spasticity after stroke. However, there is a lack of literature regarding the best protocols to use in clinical practice, as well as functional outcomes after this therapy. The objective of this research project will be to investigate the effect of electromyographic biofeedback on spasticity in individuals post-stroke in the sub-acute phase, and its outcomes regarding upper limb function and participation in activities of daily living. The study will be a randomized, triple-blind clinical trial in which the 45 participants will be divided into two groups: the experimental group will receive electromyographic biofeedback combined with functional training, and the control group will receive functional training with placebo biofeedback alone. The study hypothesis is that the use of electromyographic biofeedback contributes to improved functional outcomes and participation in activities of daily living in patients with upper limb spasticity resulting from stroke.
- Conditions
- Stroke
- Being tested
- Electromyographic Biofeedback, Sham (No Treatment)
- Keywords
- muscle spasticity, stroke, biofeedback, electromyography
- Medical subject headings
- Stroke, Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electromyographic BiofeedbackDevice
This intervention phase will last 30 minutes of training, during which the participant will be encouraged to actively and voluntarily relax their spastic muscles and will receive visual feedback through the software when this occurs. Two modes will be used in the software: the first, called "Recovery", which consists of a game in which the participant is encouraged to contract and relax their muscles in order to guide a rocket in a specific direction to earn points. The second, called "Maestro", in which the participant's objective is to keep the rocket below the specified line while maintaining their muscles relaxed. The participant will perform each mode for 15 minutes, totaling the proposed 30 minutes. There may be a break between each mode if the participant experiences fatigue. Afterward, they will receive standard occupational therapy.
Sham (No Treatment)Device
The intervention with the placebo group will have an identical structure to that of the intervention group, but during the biofeedback phase, the software screen will be a simulation, not corresponding to the patient's muscle activity. The patient will receive occupational therapy as usual, in a manner identical to that of the intervention group after the placebo biofeedback therapy.
| Study group | Role | What they receive |
|---|---|---|
| EMG Biofeedback - Intervention | Placebo comparator | This intervention phase will last 30 minutes of training, during which the participant will be encouraged to actively and voluntarily relax their spastic muscles and will receive visual feedback through the software when this occurs. Two modes will be used in the software: the first, called "Recovery", which consists of a game in which the participant is encouraged to contract and relax their muscles in order to guide a rocket in a specific direction to earn points. The second, called "Maestro", in which the participant's objective is to keep the rocket below the specified line while maintaining their muscles relaxed. The participant will perform each mode for 15 minutes, totaling the proposed 30 minutes. There may be a break between each mode if the participant experiences fatigue. Afterward, they will receive standard occupational therapy. Receives: Device: Electromyographic Biofeedback |
| EMG Biofeedback - Sham | Sham comparator | The intervention with the placebo (sham) group will have an identical structure to that of the intervention group, but during the biofeedback phase, the software screen will be a simulation, not corresponding to the patient's muscle activity. The patient will receive occupational therapy as usual, in a manner identical to that of the intervention group after the placebo biofeedback therapy. Receives: Device: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ashworth
The Ashworth scale will be used to measure the degree of spasticity of the upper limb muscles. The test will be performed manually and the score ranges from zero to four points. The higher the score, the greater the spasticity of the muscle tested.
Measured: Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.
Secondary outcomes (6)
Upper limb function and participation - The Functional Independence Measure (FIM)
The Functional Independence Measure (FIM) will be used to potentially classify the level of dependence of the subject as: complete (18 to 45 points), moderate independence (46 to 99), and full independence (100 to 126). The lower the subject's score, the more dependent they are. The minimally clinically important difference for this evaluation is 22 points.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Modified Ashworth scale
The Modified Ashworth scale will be used to measure the degree of spasticity in the upper limb musculature. The score ranges from zero to four points. The higher the score, the greater the spasticity of the tested muscle.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Motor Activity Log (MAL)
The Motor Activity Log (MAL) measures how much the upper limb is used in daily activities. The average is directly proportional to the quantity and quality of upper limb use. In both scales, the minimally clinically relevant difference is 1.0 points if the paretic limb is not dominant or 1.1 points if the paretic limb is dominant.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Box and Block Test (BBT)
In the Box and Block Test (BBT) the patient will be instructed to move as many blocks as possible from one side of the box to the other in 60 seconds, placing only one block at a time. The score obtained is equal to the number of blocks transported in one partition in one minute. It is assessed that the more blocks transported within the established time, the better the manual dexterity of the patient.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Jebsen Manual Function Test (JTT)
Jebsen Manual Function Test (JTT) will require to the participant to perform six tasks: turning cards and small common objects, simulating feeding, stacking chips, moving large light and heavy objects. Each task will be timed, and the participant will have a maximum of 120 seconds to complete each task.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Fugl-Meyer Assessment Scale
Fugl-Meyer Assessment Scale will be used to measure range of motion, coordination, reflex activity, tactile sensitivity, and proprioception of the shoulder, elbow, wrist, and hand regions. The scale can be divided into two domains: motor (66 points) and sensory (12). The scoring can be from zero to three points, where: absent function is 0, 1 (one) is partial function, and 2 (two) is normal function. The minimally clinically important difference of this scale is 10% of the gross value, which is 6.6 points in the motor domain and 1.2 points in the sensory domain. Only scores for the affected limb will be considered.
Measured: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies 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
- Model description
- Sham group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Paraná
- Sponsor type
- University, hospital or other
- Collaborators
- UTFPR
- Responsible party
- Principal investigator, Henrique Cunha Carvalho, Universidade Federal do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07149129
- Sponsor's protocol ID
- 84156424.6.0000.5547
- Other IDs
- 84156424.6.0000.5547
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethical or Consent Restrictions: Participants may not have given explicit consent for their data to be shared beyond the original study. Legal or Institutional Policies: Data sharing may be restricted by Brazillian laws.
Publications
Liu M, Xu L, Li H, Chen S, Chen B. Morphological and Functional Changes of the Tibialis Anterior Muscle After Combined Mirror Visual Feedback and Electromyographic Biofeedback in Poststroke Patients: A Randomized Trial. Am J Phys Med Rehabil. 2021 Aug 1;100(8):766-773. doi: 10.1097/PHM.0000000000001628.
PubMed 33105154Nordio S, Arcara G, Berta G, Dellai A, Brisotto C, Koch I, Cazzador D, Aspidistria M, Ventura L, Turolla A, D'Imperio D, Battel I. Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial. Dysphagia. 2022 Oct;37(5):1207-1216. doi: 10.1007/s00455-021-10385-2. Epub 2021 Nov 12.
PubMed 34767083Hou M, Zhao Y, Zhao L, Yuan X, Liu Z, Li H. Efficacy of game training combined with surface electromyography biofeedback on post-stroke dysphagia. Geriatr Nurs. 2024 Jan-Feb;55:255-262. doi: 10.1016/j.gerinurse.2023.11.019. Epub 2023 Dec 12.
PubMed 38091711Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
PubMed 27145936Feng S, Tang M, Huang G, Wang J, He S, Liu D, Gu L. EMG biofeedback combined with rehabilitation training may be the best physical therapy for improving upper limb motor function and relieving pain in patients with the post-stroke shoulder-hand syndrome: A Bayesian network meta-analysis. Front Neurol. 2023 Jan 10;13:1056156. doi: 10.3389/fneur.2022.1056156. eCollection 2022.
PubMed 36703623Woodford H, Price C. EMG biofeedback for the recovery of motor function after stroke. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD004585. doi: 10.1002/14651858.CD004585.pub2.
PubMed 17443550Elshafey MA, Abd-Elaziem A, Gouda RE. Functional stretching exercise submitted for spastic diplegic children: a randomized control study. Rehabil Res Pract. 2014;2014:814279. doi: 10.1155/2014/814279. Epub 2014 Jul 20.
PubMed 25143834Koh SH, Park HH. Neurogenesis in Stroke Recovery. Transl Stroke Res. 2017 Feb;8(1):3-13. doi: 10.1007/s12975-016-0460-z. Epub 2016 Mar 18.
PubMed 26987852
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Electromyographic Biofeedback in Upper Limb Rehabilitation After Stroke
- ClinicalTrials.gov ID
- NCT07149129
- Acronym / sponsor ID
- 84156424.6.0000.5547
- Conditions
- Stroke
- Keywords
- muscle spasticity, stroke, biofeedback, electromyography
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Universidade Federal do ParanáUniversity, hospital or other
- Collaborators
- UTFPR
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 29 Aug 2025 (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.
Studies show that the use of electromyographic biofeedback combined with other therapies contributes to the reduction of upper limb spasticity after stroke. However, there is a lack of literature regarding the best protocols to use in clinical practice, as well as functional outcomes after this therapy. The objective of this research project will be to investigate the effect of electromyographic biofeedback on spasticity in individuals post-stroke in the sub-acute phase, and its outcomes regarding upper limb function and participation in activities of daily living. The study will be a randomized, triple-blind clinical trial in which the 45 participants will be divided into two groups: the experimental group will receive electromyographic biofeedback combined with functional training, and the control group will receive functional training with placebo biofeedback alone. The study hypothesis is that the use of electromyographic biofeedback contributes to improved functional outcomes and participation in activities of daily living in patients with upper limb spasticity resulting from stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sham group
| Arm | Type | Receives |
|---|---|---|
| EMG Biofeedback - Intervention | Placebo comparator | Device: Electromyographic BiofeedbackThis intervention phase will last 30 minutes of training, during which the participant will be encouraged to actively and voluntarily relax their spastic muscles and will receive visual feedback through the software when this occurs. Two modes will be used in the software: the first, called "Recovery", which consists of a game in which the participant is encouraged to contract and relax their muscles in order to guide a rocket in a specific direction to earn points. The second, called "Maestro", in which the participant's objective is to keep the rocket below the specified line while maintaining their muscles relaxed. The participant will perform each mode for 15 minutes, totaling the proposed 30 minutes. There may be a break between each mode if the participant experiences fatigue. Afterward, they will receive standard occupational therapy. |
| EMG Biofeedback - Sham | Sham comparator | Device: Sham (No Treatment)The intervention with the placebo (sham) group will have an identical structure to that of the intervention group, but during the biofeedback phase, the software screen will be a simulation, not corresponding to the patient's muscle activity. The patient will receive occupational therapy as usual, in a manner identical to that of the intervention group after the placebo biofeedback therapy. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a clinical diagnosis of stroke (imaging tests and a medical report)
- Spasticity with an Ashworth score equal to or less than 3 in the upper limb
- 20-60 years old
Key exclusion criteria (5 listed)
- Other neurological impairments or trauma-orthopedic deformities in the upper limbs
- botulinum toxin/phenol injections within the previous 5 months
- medications that reduce muscle tone
- aphasia that prevents basic communication
- low vision or low visual acuity that prevents them from viewing the screen.
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 |
|---|---|---|
| Electromyographic BiofeedbackThis intervention phase will last 30 minutes of training, during which the participant will be encouraged to actively and voluntarily relax their spastic muscles and will receive visual feedback through the software when this occurs. Two modes will be used in the software: the first, called "Recovery", which consists of a game in which the participant is encouraged to contract and relax their muscles in order to guide a rocket in a specific direction to earn points. The second, called "Maestro", in which the participant's objective is to keep the rocket below the specified line while maintaining their muscles relaxed. The participant will perform each mode for 15 minutes, totaling the proposed 30 minutes. There may be a break between each mode if the participant experiences fatigue. Afterward, they will receive standard occupational therapy. | Device | EMG Biofeedback - Intervention |
| Sham (No Treatment)The intervention with the placebo group will have an identical structure to that of the intervention group, but during the biofeedback phase, the software screen will be a simulation, not corresponding to the patient's muscle activity. The patient will receive occupational therapy as usual, in a manner identical to that of the intervention group after the placebo biofeedback therapy. | Device | EMG Biofeedback - Sham |
Primary outcome
Ashworth
Time frame: Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.
The Ashworth scale will be used to measure the degree of spasticity of the upper limb muscles. The test will be performed manually and the score ranges from zero to four points. The higher the score, the greater the spasticity of the muscle tested.
6 secondary outcomes
Upper limb function and participation - The Functional Independence Measure (FIM)
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Modified Ashworth scale
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Motor Activity Log (MAL)
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Box and Block Test (BBT)
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Jebsen Manual Function Test (JTT)
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
Upper limb function and participation - Fugl-Meyer Assessment Scale
Time frame: The tests will be applied at pre (baseline), through study completion, an average of 1 month.
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 29 Aug 2025.
- Background: PubMed 33105154Liu M, Xu L, Li H, Chen S, Chen B. Morphological and Functional Changes of the Tibialis Anterior Muscle After Combined Mirror Visual Feedback and Electromyographic Biofeedback in Poststroke Patients: A Randomized Trial. Am J Phys Med Rehabil. 2021 Aug 1;100(8):766-773. doi: 10.1097/PHM.0000000000001628.
- Background: PubMed 34767083Nordio S, Arcara G, Berta G, Dellai A, Brisotto C, Koch I, Cazzador D, Aspidistria M, Ventura L, Turolla A, D'Imperio D, Battel I. Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial. Dysphagia. 2022 Oct;37(5):1207-1216. doi: 10.1007/s00455-021-10385-2. Epub 2021 Nov 12.
- Background: PubMed 38091711Hou M, Zhao Y, Zhao L, Yuan X, Liu Z, Li H. Efficacy of game training combined with surface electromyography biofeedback on post-stroke dysphagia. Geriatr Nurs. 2024 Jan-Feb;55:255-262. doi: 10.1016/j.gerinurse.2023.11.019. Epub 2023 Dec 12.
- Background: PubMed 27145936Winstein CJ, Stein J, Arena R, Bates B, Cherney LR, Cramer SC, Deruyter F, Eng JJ, Fisher B, Harvey RL, Lang CE, MacKay-Lyons M, Ottenbacher KJ, Pugh S, Reeves MJ, Richards LG, Stiers W, Zorowitz RD; American Heart Association Stroke Council, Council on Cardiovascular and Stroke Nursing, Council on Clinical Cardiology, and Council on Quality of Care and Outcomes Research. Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2016 Jun;47(6):e98-e169. doi: 10.1161/STR.0000000000000098. Epub 2016 May 4.
- Background: PubMed 36703623Feng S, Tang M, Huang G, Wang J, He S, Liu D, Gu L. EMG biofeedback combined with rehabilitation training may be the best physical therapy for improving upper limb motor function and relieving pain in patients with the post-stroke shoulder-hand syndrome: A Bayesian network meta-analysis. Front Neurol. 2023 Jan 10;13:1056156. doi: 10.3389/fneur.2022.1056156. eCollection 2022.
- Background: PubMed 17443550Woodford H, Price C. EMG biofeedback for the recovery of motor function after stroke. Cochrane Database Syst Rev. 2007 Apr 18;2007(2):CD004585. doi: 10.1002/14651858.CD004585.pub2.
- Background: PubMed 25143834Elshafey MA, Abd-Elaziem A, Gouda RE. Functional stretching exercise submitted for spastic diplegic children: a randomized control study. Rehabil Res Pract. 2014;2014:814279. doi: 10.1155/2014/814279. Epub 2014 Jul 20.
- Background: PubMed 26987852Koh SH, Park HH. Neurogenesis in Stroke Recovery. Transl Stroke Res. 2017 Feb;8(1):3-13. doi: 10.1007/s12975-016-0460-z. Epub 2016 Mar 18.
- Individual participant dataSharing planned: No. Ethical or Consent Restrictions: Participants may not have given explicit consent for their data to be shared beyond the original study. Legal or Institutional Policies: Data sharing may be restricted by Brazillian laws.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electromyographic Biofeedback in people with Stroke, run by Universidade Federal do Paraná at 1 site in Brazil.
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 3 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 29 Aug 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ashworth (time frame: Ashworth will be applied at pre (baseline), through study completion, an average of 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07149129, which also lists 8 linked publications.
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 29 Aug 2025.