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| Name | Class |
|---|---|
| Donum Corde Rehabilitation Center | UNKNOWN |
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among stroke | No Intervention | 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 | Experimental | 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. |
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| Control group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justyna K Leszczak, PhD | Contact | +48721581801 | jleszczak@ur.edu.pl |
| Name | Affiliation | Role |
|---|---|---|
| Justyna Leszczak, PhD | Univeristy of Rzeszów, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rzeszów | Recruiting | Rzeszów | 35-205 | Poland |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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).
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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" | 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 |
| 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. | 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 |
| 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. | 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 |
| 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 |
| 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 |
| 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 |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |