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CompletedNCT07450274ClinicalTrials.gov record

Rehabilitation of Upper Limbs After Stroke

Rehabilitation · Stroke

THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type
Interventional
Phase
Not applicable
Age range
45 years - 80 years
Sex eligible
All sexes
Healthy volunteers
Accepted
Participants
120 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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
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Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment
Random assignment
Masking
Triple masked
Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among stroke

Evaluation 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 Tyromotion

Rehabilitation 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.

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

Control group

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 upper limb exercises.

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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

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

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 measures

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

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

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

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

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

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

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"

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"

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"

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.

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.

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.

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

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

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

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

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

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

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.

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.

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 measures

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

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

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

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)

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

Open official results ↗

Research locations (1)

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1 locations

University of RzeszówRzeszów, PolandStatus unknown

Study team and timeline

Lead sponsor
University of Rzeszow
Study start
Mar 2, 2026 Actual
Primary completion
Aug 31, 2026 Actual
Study completion
Sep 30, 2026 Actual
First posted
Mar 4, 2026 Actual
Last updated
Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.

Official study title

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

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Retrieved: Nov 11, 2026 · Last registry update: Nov 10, 2026