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RehabilitationNCT07333079

Rehabilitation With Biofeedback for People After Stroke

A study testing Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices. in people with Rehabilitation and Stroke, run by University of Rzeszow at 1 site in Poland.

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 aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke. Read more about this study

Who is it for?
Ages 45 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Rehabilitation, Stroke
What is being tested?
Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePoland
Study dates
19 Jan 2026to 30 Sep 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 45 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • informed, voluntary consent of the patient
  • age 45-80 years
  • elementary (basic) gripping ability
  • degree of paresis of the upper limb and hand 4 -5 on the Brunnström scale
  • degree of disability on the Rankin scale 3
  • spastic tension of the upper limb, paresis hand not more than 3 on the modified Ashworth scale - current health condition confirmed by a medical examination, allowing participation in tests and exercises

Who cannot join

  • lack of informed, voluntary consent of the patient
  • second or subsequent stroke, hemorrhagic stroke, stroke of the brainstem and cerebellum
  • disorders of higher mental functions limiting comprehension and carrying out tasks during exercises
  • visual field disturbances
  • mechanical and thermal injuries that may limit the grasping function of the hand
  • concomitant neurological, rheumatological and orthopedic diseases, including permanent - contractures that may affect the grasping ability and locomotion
  • unstable medical condition
  • failure to complete a 3-week rehabilitation stay

Trial locations and contacts

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

Justyna Leszczak, PhD contact

+48721581801

jleszczak@ur.edu.pl

Poland1 site, 1 recruiting
  • University of Rzeszów

    Rzeszów, 35-205

    Justyna Leszczak, PhD, +48 721-581-801, leszczakjustyna.ur@gmail.com

    Recruiting

Other trials in Poland

About this study

Official title: Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke

The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.

Read the detailed description

Study participants will be randomly assigned to a study group and a control group.

  • Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device
  • Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device
  • Control group - will complete a standard spa rehabilitation program without biofeedback exercises.

The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke.

Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit.

Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence.

Measurements will be performed three times for all participants:

  • hand muscle strength assessment
  • calculated body mass index (BMI)
  • proprioceptive testing (mirror test, Thumb Location Test)
  • rehabilitation outcome assessment
  • functional capacity - Barthel Index, ADL
  • Ashworth muscle tone (spasticity)
  • hand dexterity using the Box and Blocks test
  • hand grip function according to the Frenchay scale
  • motor function of the hand and upper limb according to the Fugl-Meyer Motor Assessment Scale for Upper Extremity
Being tested
Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Keywords
Rehabilitation, Late period in stroke, Health-resort based rehabilitation, Conventional (traditional) rehabilitation, Modern technologies, Biofeedback
Medical subject headings
Stroke

What participants receive

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

  • Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.Other

    Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).

Study groups in NCT07333079
Study groupRoleWhat they receive
Group I-Biofeedback method using the Biometrics E-link device and Health-resort based rehabilitationExperimentalThe rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Biometrics E-link device.
Receives: Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Group II -Biofeedback method using the Stella Bio device and Health-resort based rehabilitation.ExperimentalThe rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Stella Bio device.
Receives: Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Health-resort based rehabilitation.No interventionHealth-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training. Health-resort based rehabilitation The rehabilitation programme will last 3 weeks from Monday to Friday. Patients will receive: group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, physical treatments such as laser, whirlpool, mud packs, carbonic acid therapy , TENS therapy, BIO-V lamp, local cryotherapy

What is being measured

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

  1. Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

    It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

    Measured: First examination - before the start of the rehabilitation program

  2. Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

    It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

    Measured: Second examination - at the end of the three-week program

  3. Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

    It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

Secondary outcomes (18)
  1. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

    Measured: First examination - before the start of the rehabilitation program

  2. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength

    Measured: Second examination - at the end of the three-week program

  3. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

  4. Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

    Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points.

    A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone.

    0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy"

    Measured: First examination - before the start of the rehabilitation program

  5. Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

    Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points.

    A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone.

    0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy"

    Measured: Second examination - at the end of the three-week program

  6. Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

    Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points.

    A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone.

    0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy"

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

  7. Manual skills, assessed with Box and Blocks test;

    The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.

    Measured: First examination - before the start of the rehabilitation program

  8. Manual skills, assessed with Box and Blocks test;

    The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.

    Measured: Second examination - at the end of the three-week program

  9. Manual skills, assessed with Box and Blocks test;

    The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

  10. Assessment of proprioception Thumb Localizing Test (TLT)

    . Thumb Localizing Test (TLT). (A) positioning of the paretic UE by the examiner. (B) four spaces in which the paretic UE is placed. Distal spaces are not far from the trunk because the reaching limb should be able to reach them without difficulty. (C) rating of positive results.

    Measured: First examination - before the start of the rehabilitation program

  11. Assessment of proprioception Thumb Localizing Test (TLT)

    . Thumb Localizing Test (TLT). (A) positioning of the paretic UE by the examiner. (B) four spaces in which the paretic UE is placed. Distal spaces are not far from the trunk because the reaching limb should be able to reach them without difficulty. (C) rating of positive results.

    Measured: Second examination - at the end of the three-week program

  12. Assessment of proprioception Thumb Localizing Test (TLT)

    . Thumb Localizing Test (TLT). (A) positioning of the paretic UE by the examiner. (B) four spaces in which the paretic UE is placed. Distal spaces are not far from the trunk because the reaching limb should be able to reach them without difficulty. (C) rating of positive results.

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

  13. Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint

    Assessments were performed with eyes closed. Proprioception of the elbow joint was assessed in the 60° elbow flexion position using a plastic Jamar goniometer. The initial fixed axis of the goniometer was set at the lateral epicondyle of the humerus, and the mobile axis was set parallel to the radius, in accordance with the methodology of the study of joint position sensation in the elbow

    Measured: First examination - before the start of the rehabilitation program

  14. Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint

    Assessments were performed with eyes closed. Proprioception of the elbow joint was assessed in the 60° elbow flexion position using a plastic Jamar goniometer. The initial fixed axis of the goniometer was set at the lateral epicondyle of the humerus, and the mobile axis was set parallel to the radius, in accordance with the methodology of the study of joint position sensation in the elbow

    Measured: Second examination - at the end of the three-week program

  15. Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint

    Assessments were performed with eyes closed. Proprioception of the elbow joint was assessed in the 60° elbow flexion position using a plastic Jamar goniometer. The initial fixed axis of the goniometer was set at the lateral epicondyle of the humerus, and the mobile axis was set parallel to the radius, in accordance with the methodology of the study of joint position sensation in the elbow

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

  16. Handgrip function, according Frenchay scale

    The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills.

    Measured: First examination - before the start of the rehabilitation program

  17. Handgrip function, according Frenchay scale

    The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills.

    Measured: Second examination - at the end of the three-week program

  18. Handgrip function, according Frenchay scale

    The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills.

    Measured: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

Timeline

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

  1. First posted12 Jan 2026
  2. Study start19 Jan 2026
  3. Primary completion30 Aug 2026 (estimated)
  4. Study completion30 Sep 2026 (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
Model description
Random selection into groups (study group I, study group II and control group).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07333079
Sponsor's protocol ID
Stroke rehabilitation
Status last verified
Feb 2026
First submitted
27 Dec 2025
Last updated
25 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices. in people with Rehabilitation and 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 6 inclusion and 8 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 25 Feb 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 Justyna Leszczak, PhD (+48721581801, jleszczak@ur.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale (time frame: First examination - before the start of the rehabilitation program). The study lists 3 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 25 Feb 2026.

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