University of Rzeszów
Rzeszów, 35-205, Poland
NCT Number: NCT05486052
The research will aim to evaluate biofeedback rehabilitation and optical oximetry assessment in neurological patients and the influence of blood parameters on the effect of the rehabilitation carried out.
An additional aim will be to evaluate components of body weight, lifestyle, dietary habits, assessment of mental state, quality of life among the study subjects.
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Notify Me20 year–75 year
All sexes
Interventional
Not applicable
Rzeszów, 35-205, Poland
Prior to the study, an assessment of the reliability, reproducibility and validity of the devices among healthy individuals will be carried out.
The subjects will be allocated, by random selection, to two groups:
Study subjects:
In addition, subjects will have blood tests taken, such as blood count, GL, TG, TC, HDL, LDL, CRP, serum glucose, cytokines, myokines, markers found in neurological diseases, and optical oximetry (nIRS device) will be measured.
Measurements will be taken three times for all subjects:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Test persons:
Exclusion criteria
Evaluation of reliability, reproducibility and validity of devices among healthy subjects Prior to the study among individuals with neurological disorders, an evaluation of the reliability, repeatability and credibility of the devices to be included in the biofeedback rehabilitation and optical oximetry measurements will be carried out.
The evaluation of the devices will be carried out by two independent researchers twice
The rehabilitation programme will run for 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 massages, physical treatments such as laser, whirlpool, mud packs, carbonic acid therapy , TENS therapy, BIO-V lamp, local cryotherapy.
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, peat wraps, carbonic acid therapy , TENS therapy, BIO-V lamp, local cryotherapy.
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
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion
Time frame: First examination - before the start of the rehabilitation program;
Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion
Time frame: Second examination - at the end of the three-week program
Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion
Time frame: First examination - before the start of the rehabilitation program;
measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion
Time frame: Second examination - at the end of the three-week program
measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170
Time frame: First examination - before the start of the rehabilitation program;
measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170
Time frame: Second examination - at the end of the three-week program
measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170
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: 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: research among healthy people, during studies from the 3rd to the 5th year of studies
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)
Time frame: First examination - before the start of the rehabilitation program
measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)
Time frame: Second examination - at the end of the three-week program
measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)
Time frame: First examination - before the start of the rehabilitation program
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780) Change from Baseline body composition at 3 weeks between baseline, after the end of protocol treatment
Time frame: Second examination - at the end of the three-week program
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Time frame: First examination - before the start of the rehabilitation program
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Time frame: Second examination - at the end of the three-week program
with the use of R 500 goniometer; the device operates with an accuracy up to one degree.
Time frame: research among healthy people, during studies from the 3rd to the 5th year of studies
EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device
Time frame: First examination - before the start of the rehabilitation program
EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device
Time frame: Second examination - at the end of the three-week program
EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device
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: First examination - before the start of the rehabilitation program
Balance was assessed using Berg balance scale (BBS)
Berg Balance Scale
Description:
14-item scale designed to measure balance
(1. Sitting to standing 2. Standing unsupported 3. Sitting unsupported 4. Standing to sitting 5. Transfers 6. Standing with eyes closed 7. Standing with feet together 8. Reaching forward with outstretched arm 9. Retrieving object from floor 10. Turning to look behind 11. Turning 360 degrees 12. Placing alternate foot on stool 13. Standing with one foot in front 14. Standing on one foot)
Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56
Interpretation: 41-56 = independent 21-40 = walking with assistance 0 -20 = wheelchair bound
Time frame: Second examination - at the end of the three-week program
Balance was assessed using Berg balance scale (BBS)
Berg Balance Scale
Description:
14-item scale designed to measure balance
(1. Sitting to standing 2. Standing unsupported 3. Sitting unsupported 4. Standing to sitting 5. Transfers 6. Standing with eyes closed 7. Standing with feet together 8. Reaching forward with outstretched arm 9. Retrieving object from floor 10. Turning to look behind 11. Turning 360 degrees 12. Placing alternate foot on stool 13. Standing with one foot in front 14. Standing on one foot)
Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56
Interpretation: 41-56 = independent 21-40 = walking with assistance 0 -20 = wheelchair bound
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
Time frame: Second examination - at the end of the three-week 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
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: Second examination - at the end of the three-week 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
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: Second examination - at the end of the three-week 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
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: 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: First examination - before the start of the rehabilitation program
Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements.
Individual tasks are assessed on a scale 0-2 0 - impossible task
Time frame: Second examination - at the end of the three-week program
Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements.
Individual tasks are assessed on a scale 0-2 0 - impossible task
Time frame: First examination - before the start of the rehabilitation program
the GMFCS is a 5-step assessment system for functioning and mobility in daily life.
Time frame: Second examination - at the end of the three-week program
the GMFCS is a 5-step assessment system for functioning and mobility in daily life.
Time frame: First examination - before the start of the rehabilitation program
The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands when handling objects in everyday life. The MACS includes five levels. The assignment of a specific level to a child is based on the child's initiated activity during which they use objects, and whether the child needs the help of another person or the adaptation of equipment to be able to use them in everyday activities. The MACS booklet also describes the differences between adjacent levels to make it easier to determine which level best describes the child's ability to use objects.
Time frame: Second examination - at the end of the three-week program
The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands when handling objects in everyday life. The MACS includes five levels. The assignment of a specific level to a child is based on the child's initiated activity during which they use objects, and whether the child needs the help of another person or the adaptation of equipment to be able to use them in everyday activities. The MACS booklet also describes the differences between adjacent levels to make it easier to determine which level best describes the child's ability to use objects.
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
HDL level:
Men:
Less than 35 mg / dL (0.9 mmol / L) high risk of heart disease.
Women:
Lower than 45 mg / dL (1.2 mmol / L) high risk of heart disease. 60 mg / dL (1.56 mmol / L) and above. High HDL cholesterol.
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
HDL level:
Men:
Less than 35 mg / dL (0.9 mmol / L) high risk of heart disease.
Women:
Lower than 45 mg / dL (1.2 mmol / L) high risk of heart disease. 60 mg / dL (1.56 mmol / L) and above. High HDL cholesterol.
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
LDL level:
Less than 100 mg / dL (2.6 mmol / L) Norm 100 - 129 mg / dL (2.63.34 mmol / L) Above the norm 130 - 159 mg / dL (3.36 - 4.13 mmol / L) Limit 160 - 189 mg / dL (4.14 - 4.90 mmol / L) High 190 mg / dL (4.91 mmol / L) and above Very high
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
LDL level:
Less than 100 mg / dL (2.6 mmol / L) Norm 100 - 129 mg / dL (2.63.34 mmol / L) Above the norm 130 - 159 mg / dL (3.36 - 4.13 mmol / L) Limit 160 - 189 mg / dL (4.14 - 4.90 mmol / L) High 190 mg / dL (4.91 mmol / L) and above Very high
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
Total Cholesterol level:
Less than 200 mg / dL (5.17 mmol / L) Norm 200 - 239 mg / dL (5.17 - 6.18 mmol / L) Elevated level 240 mg / dL (6.21 mmol / L) High risk of heart disease
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
Total Cholesterol level:
Less than 200 mg / dL (5.17 mmol / L) Norm 200 - 239 mg / dL (5.17 - 6.18 mmol / L) Elevated level 240 mg / dL (6.21 mmol / L) High risk of heart disease
Time frame: First examination - before the start of the rehabilitation program
The type of obesity is assessed with the so-called waist-to-hip ratio (WHR), which shows the proportion of waist circumference and hip circumference. WHR specifies the location of excessive fat and makes it possible to identify two main types of obesity: visceral obesity (characteristic for men), connected with accumulation of fat in the abdominal cavity and upper part of the body, and gynoid obesity (gluteal-femoral), more common in women.
Time frame: Second examination - at the end of the three-week program
The type of obesity is assessed with the so-called waist-to-hip ratio (WHR), which shows the proportion of waist circumference and hip circumference. WHR specifies the location of excessive fat and makes it possible to identify two main types of obesity: visceral obesity (characteristic for men), connected with accumulation of fat in the abdominal cavity and upper part of the body, and gynoid obesity (gluteal-femoral), more common in women.
Time frame: First examination - before the start of the rehabilitation program
Metabolic syndrome (polymetabolic syndrome, syndrome X, insulin resistance syndrome, Reaven syndrome) - a set of interrelated factors significantly increasing the risk of atherosclerosis and type 2 diabetes, as well as their vascular complications.
Abdominal (central) obesity
At least three of the following five abnormalities must be identified to formulate a diagnosis:
abdominal obesity (waist circumference in men from Europe ≥ 94 cm, and in women ≥ 80 cm) and additionally co-existing two of the following abnormalities: triglycerides ≥ 150 mg/dl or dyslipidaemia related treatment cholesterol HDL < 40 mg/dl in males < 50 mg/dl in females or dyslipidaemia related treatment arterial pressure ≥ 130/85 mm Hg or arterial pressure related treatment fasting glycaemia ≥ 100 mg/dl or type 2 diabetes treatment
Time frame: Second examination - at the end of the three-week program
Metabolic syndrome (polymetabolic syndrome, syndrome X, insulin resistance syndrome, Reaven syndrome) - a set of interrelated factors significantly increasing the risk of atherosclerosis and type 2 diabetes, as well as their vascular complications.
Abdominal (central) obesity
At least three of the following five abnormalities must be identified to formulate a diagnosis:
abdominal obesity (waist circumference in men from Europe ≥ 94 cm, and in women ≥ 80 cm) and additionally co-existing two of the following abnormalities: triglycerides ≥ 150 mg/dl or dyslipidaemia related treatment cholesterol HDL < 40 mg/dl in males < 50 mg/dl in females or dyslipidaemia related treatment arterial pressure ≥ 130/85 mm Hg or arterial pressure related treatment fasting glycaemia ≥ 100 mg/dl or type 2 diabetes treatment
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
TG level:
Below 150mg / dL (1.69mmol / L) Norm 150 - 199 mg / dL (1.69 - 2.25 mmol / L) Limit 200 - 499 mg / dL (2.26 - 5.63 mmol / L) High Above 500 mg / dL (5.64 mmol / L) Very high
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
TG level:
Below 150mg / dL (1.69mmol / L) Norm 150 - 199 mg / dL (1.69 - 2.25 mmol / L) Limit 200 - 499 mg / dL (2.26 - 5.63 mmol / L) High Above 500 mg / dL (5.64 mmol / L) Very high
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
atherogenic index level
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
atherogenic index level
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
CRP level:
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
CRP level:
Time frame: First examination - before the start of the rehabilitation program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
serum glucose level: From 70 to 99 mg / dL (from 3.9 to 5.5 mmol / L) Normal glucose level From 100 to 125 mg / dL (from 5.6 to 6.9 mmol / L) Abnormal fasting glucose (pre-diabetes) From 126 mg / dL (7.0 mmol / L) Diabetes
Time frame: Second examination - at the end of the three-week program
Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.
serum glucose level: From 70 to 99 mg / dL (from 3.9 to 5.5 mmol / L) Normal glucose level From 100 to 125 mg / dL (from 5.6 to 6.9 mmol / L) Abnormal fasting glucose (pre-diabetes) From 126 mg / dL (7.0 mmol / L) Diabetes
University of Rzeszow
Other
Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases
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