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NCT Number: NCT07450274

Rehabilitation of Upper Limbs 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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: First examination - before the start of the rehabilitation program

    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

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

    Time frame: Second examination - at the end of the three-week program

    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

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

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

    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

Secondary outcomes

  1. Hand grip strength

    Time frame: First examination - before the start of the rehabilitation program

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

  2. Hand grip strength

    Time frame: Second examination - at the end of the three-week program

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

  3. Hand grip strength

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

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

  4. pinching strength of the fingers

    Time frame: First examination - before the start of the rehabilitation program

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

  5. pinching strength of the fingers

    Time frame: Second examination - at the end of the three-week program

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

  6. pinching strength of the fingers

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

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

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

    Time frame: First examination - before the start of the rehabilitation program

    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"

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

    Time frame: Second examination - at the end of the three-week program

    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"

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

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

    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"

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

    Time frame: First examination - before the start of the rehabilitation program

    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.

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

    Time frame: Second examination - at the end of the three-week program

    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.

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

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

    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.

  13. Assessment of proprioception Thumb Localizing Test (TLT)

    Time frame: First examination - before the start of the rehabilitation program

    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

  14. Assessment of proprioception Thumb Localizing Test (TLT)

    Time frame: Second examination - at the end of the three-week program

    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

  15. Assessment of proprioception Thumb Localizing Test (TLT)

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

    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

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

    Time frame: 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

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

    Time frame: Second examination - at the end of the three-week 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

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

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

    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

  19. Handgrip function, according Frenchay scale

    Time frame: First examination - before the start of the rehabilitation program

    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.

  20. Handgrip function, according Frenchay scale

    Time frame: Second examination - at the end of the three-week program

    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.

  21. Handgrip function, according Frenchay scale

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

    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.

Other outcomes

  1. Assessment of muscle tone (spasticity) was examined with modified Ashworth scale

    Time frame: First examination - before the start of the rehabilitation program

    Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1.

    0: No increase in muscle tone

    Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension

  2. Assessment of disability level, using the modified Rankin scale (MRS)

    Time frame: First examination - before the start of the rehabilitation program

    Assessment of disability using the modified Rankin scale (MRS)

    Score Description 0 - No symptoms at all

    1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL

  3. Assessment of paretic limb function was assessed using the Brunnström scale

    Time frame: First examination - before the start of the rehabilitation program

    Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities

  4. Body mass index (BMI)

    Time frame: First examination - before the start of the rehabilitation program

    WHO BMI classification for adults:

    < 18.5 - Underweight (including: <16.0 starvation, 16.0-16.9 emaciation, 17.0-18.4 underweight) 18.5-24.9 - Normal body weight 25.0-29.9 - Overweight 30.0-34.9 - Class I obesity 35.0-39.9 - Class II obesity (clinical obesity)

    ≥ 40.0 - Class III obesity (extreme obesity)

Study contacts

Contact information is provided by the study sponsor or research team.

Justyna K Leszczak, PhD

CONTACT

[email protected]

+48721581801

Sponsors and collaborators

Lead sponsor

University of Rzeszow

Other

Collaborators

  • Donum Corde Rehabilitation Center

Registry information

Official study title

Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 4, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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