The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
Study participants will be randomly assigned to a study group and a control group. * Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device * Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device * Control group - will complete a standard spa rehabilitation program without biofeedback exercises. The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke. Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit. Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence. Measurements will be performed three times for all participants: * hand muscle strength assessment * 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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).
University of Rzeszów
Rzeszów, Poland
RECRUITINGMotor 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
Time frame: 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
Time frame: 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
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
Hand grip strength
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
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength
Time frame: 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,
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Time frame: Third study (flow-up) - 3 months after hospital 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"
Time frame: 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"
Time frame: 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"
Time frame: Third study (flow-up) - 3 months after hospital 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.
Time frame: 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.
Time frame: 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.
Time frame: Third study (flow-up) - 3 months after hospital 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.
Time frame: 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.
Time frame: 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.
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint
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
Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint
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
Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint
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) - 3 months after hospital 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.
Time frame: 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.
Time frame: 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.
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit