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Rehabilitation of Upper Limbs After Stroke

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07450274
Enrollment
120
Registered
2026-03-04
Start date
2026-03-02
Completion date
2026-09-30
Last updated
2026-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rehabilitation, Stroke

Keywords

upper limb, hand, rehabilitation, biofeedback, modern technologies

Brief 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.

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

Interventions

OTHERRehabilitation 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.

Sponsors

University of Rzeszow
Lead SponsorOTHER
Donum Corde Rehabilitation Center
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Intervention 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).

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment ScaleFirst examination - before the start of the rehabilitation programIt 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

MeasureTime frameDescription
Hand grip strengthFirst examination - before the start of the rehabilitation programmeasurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg
pinching strength of the fingersFirst examination - before the start of the rehabilitation programmeasurements 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.First examination - before the start of the rehabilitation programActivities 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;First examination - before the start of the rehabilitation programThe 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)First examination - before the start of the rehabilitation programThumb 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 programFirst examination - before the start of the rehabilitation programAssessments 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 scaleFirst examination - before the start of the rehabilitation programThe 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.

Countries

Poland

Contacts

CONTACTJustyna K Leszczak, PhD
jleszczak@ur.edu.pl+48721581801
PRINCIPAL_INVESTIGATORJustyna Leszczak, PhD

Univeristy of Rzeszów,

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026