StrokeNCT07262528
fNIRS Neurofeedback for Post-stroke Hand Rehabilitation
A study testing Standard Rehabilitation supplemented with Biofeedback HEG and Standard Rehabilitation in people with Stroke, run by University of Rzeszow at 1 site in Poland.
Trial summary
Cardiovascular diseases are one of the main causes of disability. Among post-stroke individuals, 80% experience upper limb dysfunction, while only 5% to 20% of individuals regain full limb and hand function. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Standard Rehabilitation supplemented with Biofeedback HEG and Standard Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2025to 6 May 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with hemiparesis after a first ischemic stroke,
- subacute stroke period (no longer than 3 months),
- upper limb paresis rated 2-4 by Brunnstrom recovery stages,
- participants aged 18 to 70 years,
- consent to participate in the study.
Who cannot join
- unstable general condition,
- visual field disorders,
- inability to sit independently,
- cognitive impairment (Mini-Mental State Examination, MMSE > 24).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
University of Rzeszów
Rzeszów, 35-959
Agnieszka Guzik, + 48 17 872 10 00, aguzik@ur.edu.pl
About this study
Official title: Hand Rehabilitation in People With Hemiparesis After a Stroke Using 3D Imaging With fNIRS Neurofeedback
Cardiovascular diseases are one of the main causes of disability. Among post-stroke individuals, 80% experience upper limb dysfunction, while only 5% to 20% of individuals regain full limb and hand function. The purpose of this study is to evaluate the effects of hand rehabilitation of post-stroke individuals using HEG Neurofeedback The study will include 30 participants in the early sub-acute phase post-stroke, who will be assigned to either the study group or the control group. Participants in the experimental group will follow a rehabilitation program extended with HEG Neurofeedback training, while participants in the control group will follow the standard rehabilitation program.
The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement.
Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.
Read the detailed description
This study is a prospective, randomized, single-blind clinical trial with intervention. Participants will be recruited from among patients treated at the Rehabilitation Clinic. Inclusion criteria: individuals with hemiparesis after a first ischemic stroke, subacute stroke period (no longer than 3 months), upper limb paresis rated 2-4 by Brunnstrom recovery stages, participants aged 18 to 70 years, consent to participate in the study. Exclusion criteria: unstable general condition, visual field disorders, inability to sit independently, cognitive impairment (Mini-Mental State Examination, MMSE > 24). The minimum size of the sample was calculated taking into account the number of individuals after stroke hospitalized annually in the re habilitation ward, i.e. approximately 120 patients, of which those in the acute phase of recovery constitute about 40%. It was assumed that 80% of the patients would have a minimum 2 in Brunnstrom scale. A fraction size of 0.8 was used, with a maximum error of 5%, a sample size of 30 patients was obtained.
The allocation of interventions will be determined based on a simple randomization sequence generated using Microsoft Excel. The study coordinator will register participants, generate the random allocation sequence, and assign and schedule participants for the interventions.
Fifteen participants will be assigned to the experimental group and fifteen to the control group.
Interwention. The experimental group will be provided with rehabilitation at the Rehabilitation Clinic and additional exercises with Biofeedback HEG. HEG therapy will be conducted for 15 days, every day from Monday to Friday. The duration of one session is 30 minutes. Participants from the control group will be provided with rehabilitation at the Rehabilitation Clinic and an additional 30 minutes of individual physiotherapy focused on restoring hand function.
Participants will be assessed twice, before the start of the therapy series and immediately after its completion. Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.
- Conditions
- Stroke
- Being tested
- Standard Rehabilitation supplemented with Biofeedback HEG, Standard Rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Rehabilitation supplemented with Biofeedback HEGOther
The experimental group will be provided with rehabilitation at the Rehabilitation Clinic and additional exercises with Biofeedback HEG. HEG therapy will be conducted for 15 days, every day from Monday to Friday. The duration of one session is 30 minutes. The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement.
Standard RehabilitationOther
Participants from the control group will be provided with rehabilitation at the Rehabilitation Clinic and an additional 30 minutes of individual physiotherapy focused on restoring hand function.
| Study group | Role | What they receive |
|---|---|---|
| Standard Rehabilitation supplemented with Biofeedback HEG | Experimental | Not described Receives: Other: Standard Rehabilitation supplemented with Biofeedback HEG |
| Control: Standard Rehabilitation | Other | Not described Receives: Other: Standard Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)
Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.
Measured: Baseline (Day 1)
Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)
Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.
Measured: Immediately after therapy completion (Day 15)
Hand motor control - Brunnström Recovery Stages (Hand Section)
Assessment will be performed using the hand section of the Brunnström Recovery Stages to classify the stage of motor recovery in the affected hand. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.
Measured: Baseline (Day 1)
Hand motor control - Brunnström Recovery Stages (Hand Section)
Assessment will be repeated using the Brunnström Recovery Stages to determine any progression in hand motor recovery. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.
Measured: Immediately after therapy completion (Day 15)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Dec 2025
- Primary completion15 Jan 2026
- Study completion6 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnieszka Guzik, PhD, University of Rzeszow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262528
- Sponsor's protocol ID
- 8/01/2020
- Status last verified
- Apr 2026
- First submitted
- 28 Sep 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hand Rehabilitation in People With Hemiparesis After a Stroke Using 3D Imaging With fNIRS Neurofeedback
- ClinicalTrials.gov ID
- NCT07262528
- Acronym / sponsor ID
- 8/01/2020
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 6 May 2026 (estimated)
- First posted
- 3 Dec 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.
Cardiovascular diseases are one of the main causes of disability. Among post-stroke individuals, 80% experience upper limb dysfunction, while only 5% to 20% of individuals regain full limb and hand function. The purpose of this study is to evaluate the effects of hand rehabilitation of post-stroke individuals using HEG Neurofeedback The study will include 30 participants in the early sub-acute phase post-stroke, who will be assigned to either the study group or the control group. Participants in the experimental group will follow a rehabilitation program extended with HEG Neurofeedback training, while participants in the control group will follow the standard rehabilitation program.
The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement.
Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.
Detailed description
This study is a prospective, randomized, single-blind clinical trial with intervention. Participants will be recruited from among patients treated at the Rehabilitation Clinic. Inclusion criteria: individuals with hemiparesis after a first ischemic stroke, subacute stroke period (no longer than 3 months), upper limb paresis rated 2-4 by Brunnstrom recovery stages, participants aged 18 to 70 years, consent to participate in the study. Exclusion criteria: unstable general condition, visual field disorders, inability to sit independently, cognitive impairment (Mini-Mental State Examination, MMSE > 24). The minimum size of the sample was calculated taking into account the number of individuals after stroke hospitalized annually in the re habilitation ward, i.e. approximately 120 patients, of which those in the acute phase of recovery constitute about 40%. It was assumed that 80% of the patients would have a minimum 2 in Brunnstrom scale. A fraction size of 0.8 was used, with a maximum error of 5%, a sample size of 30 patients was obtained.
The allocation of interventions will be determined based on a simple randomization sequence generated using Microsoft Excel. The study coordinator will register participants, generate the random allocation sequence, and assign and schedule participants for the interventions.
Fifteen participants will be assigned to the experimental group and fifteen to the control group.
Interwention. The experimental group will be provided with rehabilitation at the Rehabilitation Clinic and additional exercises with Biofeedback HEG. HEG therapy will be conducted for 15 days, every day from Monday to Friday. The duration of one session is 30 minutes. Participants from the control group will be provided with rehabilitation at the Rehabilitation Clinic and an additional 30 minutes of individual physiotherapy focused on restoring hand function.
Participants will be assessed twice, before the start of the therapy series and immediately after its completion. Motor control of the hand will be assessed using the Fugl-Meyer Scale and Brunnström recovery stages.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Rehabilitation supplemented with Biofeedback HEG | Experimental | Other: Standard Rehabilitation supplemented with Biofeedback HEG |
| Control: Standard Rehabilitation | Other | Other: Standard Rehabilitation |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- individuals with hemiparesis after a first ischemic stroke,
- subacute stroke period (no longer than 3 months),
- upper limb paresis rated 2-4 by Brunnstrom recovery stages,
- participants aged 18 to 70 years,
- consent to participate in the study.
Key exclusion criteria (4 listed)
- unstable general condition,
- visual field disorders,
- inability to sit independently,
- cognitive impairment (Mini-Mental State Examination, MMSE > 24).
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 |
|---|---|---|
| Standard Rehabilitation supplemented with Biofeedback HEGThe experimental group will be provided with rehabilitation at the Rehabilitation Clinic and additional exercises with Biofeedback HEG. HEG therapy will be conducted for 15 days, every day from Monday to Friday. The duration of one session is 30 minutes. The HEG Neurofeedback therapy equipment will be supplemented with new hand therapy software. During the exercises, patients will focus on a discussed and presented task, and once the expected level of concentration is reached, the software will trigger a virtual hand performing a finger flexion movement. | Other | Standard Rehabilitation supplemented with Biofeedback HEG |
| Standard RehabilitationParticipants from the control group will be provided with rehabilitation at the Rehabilitation Clinic and an additional 30 minutes of individual physiotherapy focused on restoring hand function. | Other | Control: Standard Rehabilitation |
Primary outcome
Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)
Time frame: Baseline (Day 1)
Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.
Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section)
Time frame: Immediately after therapy completion (Day 15)
Assessment will be performed using the Fugl-Meyer Assessment for the upper limb, including wrist and hand function, to evaluate motor recovery after stroke. The wrist section has a minimum score of 0 and a maximum score of 10, while the hand section has a minimum score of 0 and a maximum score of 14. In both sections, higher scores indicate better motor function.
Hand motor control - Brunnström Recovery Stages (Hand Section)
Time frame: Baseline (Day 1)
Assessment will be performed using the hand section of the Brunnström Recovery Stages to classify the stage of motor recovery in the affected hand. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.
Hand motor control - Brunnström Recovery Stages (Hand Section)
Time frame: Immediately after therapy completion (Day 15)
Assessment will be repeated using the Brunnström Recovery Stages to determine any progression in hand motor recovery. The scale has a minimum value of 1 and a maximum value of 6. Higher values indicate better motor function and greater voluntary control of hand movements.
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 21 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Rehabilitation supplemented with Biofeedback HEG and Standard Rehabilitation in people with Stroke, run by University of Rzeszow at 1 site in Poland.
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 5 inclusion and 4 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 21 Apr 2026. 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 Poland. 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 Agnieszka Guzik (+48 17 851 8965, aguzik@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hand motor control - Fugl-Meyer Assessment (Upper Limb, Wrist, and Hand Section) (time frame: Baseline (Day 1)). The study lists 4 primary outcomes in all. 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 21 Apr 2026.