Rehabilitation of Upper Limbs After Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Rehabilitation
• Intervention / Treatment: Other: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.

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

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justyna K Leszczak, PhD; Phone Number: +48721581801; Email: jleszczak@ur.edu.pl

Study Locations

• Poland
  • Rzeszów, Poland, 35-205
    • Recruiting
    • University of Rzeszow
    • Contact: Justyna Leszczak, PhD; Phone Number: +48 721-581-801; Email: leszczakjustyna.ur@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: 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.; 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	First examination - before the start of the rehabilitation program
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	Second examination - at the end of the three-week program
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	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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"	First examination - before the start of the rehabilitation program
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"	Second examination - at the end of the three-week program
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.	First examination - before the start of the rehabilitation program
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.	Second examination - at the end of the three-week program
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.	First examination - before the start of the rehabilitation program
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.	Second examination - at the end of the three-week program
Hand grip strength	measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg	First examination - before the start of the rehabilitation program
Hand grip strength	measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg	Second examination - at the end of the three-week program
Hand grip strength	measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
pinching strength of the fingers	measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg	First examination - before the start of the rehabilitation program
pinching strength of the fingers	measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg	Second examination - at the end of the three-week program
pinching strength of the fingers	measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
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"	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
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.	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
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	First examination - before the start of the rehabilitation program
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	Second examination - at the end of the three-week program
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	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
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
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	Second examination - at the end of the three-week program
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	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
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.	Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of paretic limb function was assessed using the Brunnström scale	Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities	First examination - before the start of the rehabilitation program
Body mass index (BMI)	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)	First examination - before the start of the rehabilitation program
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale	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	First examination - before the start of the rehabilitation program
Assessment of disability level, using the modified Rankin scale (MRS)	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	First examination - before the start of the rehabilitation program

Collaborators and Investigators

• Sponsor: University of Rzeszow
• Collaborators: Donum Corde Rehabilitation Center
• Investigators: Principal Investigator: Justyna Leszczak, PhD, Univeristy of Rzeszów,

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: biofeedback; rehabilitation; upper limb; hand; modern technologies
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: Neurorehabilitation upper limb

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No