University of Rzeszów
Rzeszów, 35-205, Poland
Location status: Recruiting
NCT Number: NCT07450274
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.
Interested in participating?
Request Info45 year–80 year
All sexes
Interventional
Not applicable
Rzeszów, 35-205, Poland
Location status: Recruiting
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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
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
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
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
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
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
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
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
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
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"
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"
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"
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.
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.
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.
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
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
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
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
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
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
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.
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.
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.
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
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
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
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)
Contact information is provided by the study sponsor or research team.
University of Rzeszow
Other
Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke
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