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RehabilitationNCT07450274

Rehabilitation of Upper Limbs After Stroke

A study testing Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. 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 the effects of upper limb rehabilitation using modern Pablo Tyromotion technologies in people after stroke in the late period. 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?
Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 sitePoland
Study dates
2 Mar 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 K 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 Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke

The aim of the research will be to evaluate the effects of upper limb rehabilitation using modern Pablo Tyromotion technologies in people after stroke in the late period.

Read the detailed description

Prior to the study, an assessment of the reliability, reproducibility and validity of the devices among stroke individuals will be carried out.

The research will be conducted among people who have suffered a stroke in the late period.

The subjects will be allocated, by random selection, to two groups:

The study group will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Pablo Tyromotion device.

The control group will participate in conventional rehabilitation without biofeedback exercises.

Patients will undergo ongoing rehabilitation at the Donum Corde Rehabilitation and Medical Care Center (four weeks). The first examination will be performed on the day of admission, the second on the day of discharge, and the third (control) one month after discharge, during a follow-up visit.

Measurements will be performed three times for all participants:

  • assessment of hand and finger muscle strength
  • 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
Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
Keywords
upper limb, hand, rehabilitation, biofeedback, modern technologies
Medical subject headings
Stroke

What participants receive

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

  • Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.Other

    Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. The rehabilitation program will last 4 weeks from Monday to Friday.

Study groups in NCT07450274
Study groupRoleWhat they receive
Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among strokeNo interventionEvaluation of reliability, repeatability and validity of device Pablo Tyromotion among stroke. Prior to the study among individuals with stroke, an evaluation of the reliability, repeatability and credibility of the Pablo Tyromotion to be included in the biofeedback rehabilitation. The evaluation of the Pablo Tyromotion will be carried out by two independent researchers twice.
Study group using Pablo TyromotionExperimentalRehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. In the control group, patients will complete a 3.5-hour daily rehabilitation program. The program will include two hours of individual therapy with a physiotherapist, one hour of verticalization, and 30 minutes of exercises on the Pablo Tyromotion device.
Receives: Other: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
Control groupNo interventionIn the control group, patients will complete a 3.5-hour daily rehabilitation program. The program will include two hours of individual therapy with a physiotherapist, one hour of verticalization, and 30 minutes of upper limb exercises.

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) - month after Rehabilitation Center discharge, during a follow-up visit

Secondary outcomes (21)
  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 lower than up to 90 kg

    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) - month after Rehabilitation Center discharge, during a follow-up visit

  4. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg

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

  5. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg

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

  6. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg

    Measured: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit

  7. 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

  8. 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

  9. 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) - month after Rehabilitation Center discharge, during a follow-up visit

  10. 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

  11. 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

  12. 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) - month after Rehabilitation Center discharge, during a follow-up visit

  13. 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

  14. 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

  15. 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) - month after Rehabilitation Center discharge, during a follow-up visit

  16. First examination - before the start of the rehabilitation program

    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

  17. First examination - before the start of the rehabilitation program

    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

  18. First examination - before the start of the rehabilitation program

    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) - month after Rehabilitation Center discharge, during a follow-up visit

  19. 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

  20. 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

  21. 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) - month after Rehabilitation Center 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 posted4 Mar 2026
  2. Study start2 Mar 2026
  3. Primary completion31 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
Before starting the study, the reliability, repeatability and validity of the Pablo Tyromotion device will be assessed among people after stroke, followed by random selection into two groups (research group and control group).
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07450274
Sponsor's protocol ID
Neurorehabilitation upper limb
Status last verified
Mar 2026
First submitted
26 Feb 2026
Last updated
13 Mar 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 Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. 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 7 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 13 Mar 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 K 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 13 Mar 2026.

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