Rehabilitation With Biofeedback for 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

The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Biometrics E-link device.

Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Stella Bio device.

Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.

Health-resort based rehabilitation The rehabilitation programme will last 3 weeks from Monday to Friday. Patients will receive: group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, physical treatments such as laser, whirlpool, mud packs, carbonic acid therapy , TENS therapy, BIO-V lamp, local cryotherapy

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).

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) - 3 months after hospital 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

Time frame: Third study (flow-up) - 3 months after hospital 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

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) - 3 months after hospital 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) - 3 months after hospital 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) - 3 months after hospital 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) - 3 months after hospital 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) - 3 months after hospital 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 \[Time Frame: First examination - before the start of the rehabilitation program\]

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 (0-6):

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)

Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke