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RehabilitationNCT05486052

Rehabilitation With Biofeedback in Neurology

A study testing Evaluation of reliability, repeatability and validity of devices among healthy subjects and Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training in people with Rehabilitation and Biofeedback, run by University of Rzeszow at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Rehabilitation, Biofeedback, Neurological Diseases
What is being tested?
Evaluation of reliability, repeatability and validity of devices among healthy subjects and Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
1 sitePoland
Study dates
1 Aug 2022to 28 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • informed, voluntary consent of the patient
  • age 21-75 years
  • elementary (basic) gripping ability
  • degree of paresis of the upper limb and hand 4 -5 on the Brunnström scale
  • degree of disability on the Rankin scale 3
  • spastic tension of the upper limb, paresis hand not more than 3 on the modified Ashworth scale - current health condition confirmed by a medical examination, allowing participation in tests and exercises
Show all 13Show fewer
  • Test persons:
  • after a stroke;
  • Craniocerebral trauma;
  • Multiple sclerosis;
  • Cerebral Palsy;
  • Parkinson's disease
  • Total or partial spinal cord injury

Who cannot join

  • lack of informed, voluntary consent of the patient
  • second or subsequent stroke, hemorrhagic stroke, stroke of the brainstem and cerebellum
  • disorders of higher mental functions limiting comprehension and carrying out tasks during exercises
  • visual field disturbances
  • mechanical and thermal injuries that may limit the grasping function of the hand
  • concomitant neurological, rheumatological and orthopedic diseases, including permanent contractures that may affect the grasping ability and locomotion
Show all 9Show fewer
  • unstable medical condition
  • metal implants, electronic implants, menstruation in women, epilepsy,
  • failure to complete a 3-week rehabilitation stay

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • University of Rzeszów

    Rzeszów, 35-205

Other trials in Poland

About this study

Official title: Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases

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.

Read the detailed description

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:

  • a study group (60 subjects) - following a conventional rehabilitation programme supplemented additionally with biofeedback training

Study subjects:

  • Post-stroke condition;
  • Craniocerebral trauma;
  • Multiple Sclerosis;
  • Cerebral Palsy;
  • Parkinson's disease
  • Complete or partial spinal cord injury The group of subjects are patients staying at the Health Resort and Rehabilitation Hospital in Iwonicz Zdrój. The subjects will have a comprehensive rehabilitation with additional exercises/therapies using modern equipment (Biometrics, Luna EMG, HEG, Vectis, Rotor) with the biofeedback method (the study group). Control group - standard sanatorium rehabilitation programme without biofeedback exercises. Patients will have an ongoing rehabilitation period in hospital (3 weeks). The first examination will be carried out on the day of admission to hospital, the second examination on the day of discharge and, 3 months after leaving hospital, the third examination (follow-up) during the follow-up visit.

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:

  • assessment of hand muscle strength
  • ranges of motion of hand joints
  • analysis of body composition using the Tanita 780 MA analyser (body fat, lean tissue, muscle tissue, body water content
  • calculated body mass index (BMI)
  • examination of deep sensation (mirror test)
  • evaluation of the effects of rehabilitation
  • functional capacity - Barthel index, ADL
  • Ashworth muscle tension (spasticity)
  • Manual dexterity of the hand using the Box and Blocks test
  • grip function of the hand according to Franchay scale
  • Motor abilities of the hand according to Fugl-Meyer Motor Assessment Scale for Upper Extremity
  • EDSS scale
  • WHOQOL-BREF quality of life scale
  • Berg scale
  • GMFCS scale
  • MACS scale
  • PEDI scale
  • GMFM scale
  • Assessment of health related behaviours, eating habits, lifestyle, quality of life - standardised questionnaires. In addition, participants in the study will complete a survey questionnaire containing information on, among other things, education, marital status, place of residence.
Being tested
Evaluation of reliability, repeatability and validity of devices among healthy subjects, Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training, Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.
Keywords
Rehabilitation, Health-resort based rehabilitation, Conventional (traditional) rehabilitation, Lipid profile, Optical oximetry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Evaluation of reliability, repeatability and validity of devices among healthy subjectsOther

    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

  • Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback trainingOther

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

    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

Study groups in NCT05486052
Study groupRoleWhat they receive
Evaluation of reliability, repeatability and validity of devices among healthy subjectsOtherEvaluation of the reliability, repeatability and credibility of biofeedback-based devices such as Biometrics, Luna EMG, Vectis, Rotor and nIRS among healthy individuals
Receives: Other: Evaluation of reliability, repeatability and validity of devices among healthy subjects
Biofeedback method and Health-resort based rehabilitationOtherHealth-resort based treatments supplemented with biofeedback training
Receives: Other: Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training; Other: Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.
Health-resort based rehabilitationOtherControl group - health-resort based treatments, without biofeedback training.
Receives: Other: Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. assessment of prioprioception (deep sensation)

    Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  2. assessment of prioprioception (deep sensation)

    Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

    Measured: First examination - before the start of the rehabilitation program;

  3. assessment of prioprioception (deep sensation)

    Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

    Measured: Second examination - at the end of the three-week program

  4. assessment of muscle tone (spasticity)

    measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  5. assessment of muscle tone (spasticity)

    measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

    Measured: First examination - before the start of the rehabilitation program;

  6. assessment of muscle tone (spasticity)

    measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

    Measured: Second examination - at the end of the three-week program

  7. ranges of movements in the shoulder joint

    measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  8. ranges of movements in the shoulder joint

    measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

    Measured: First examination - before the start of the rehabilitation program;

  9. ranges of movements in the shoulder joint

    measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

    Measured: Second examination - at the end of the three-week program

  10. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

    Measured: First examination - before the start of the rehabilitation program;

  11. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

    Measured: Second examination - at the end of the three-week program

  12. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

    Measured: First examination - before the start of the rehabilitation program

  13. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

    Measured: Second examination - at the end of the three-week program

  14. Hand grip strength

    measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  15. pinching strength of the fingers

    measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  16. optical oximetry

    measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  17. optical oximetry

    measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

    Measured: First examination - before the start of the rehabilitation program

  18. optical oximetry

    measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

    Measured: Second examination - at the end of the three-week program

  19. Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.

    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

    Measured: First examination - before the start of the rehabilitation program

  20. Change Body composition assessment (fat mass, visceral fat level , muscle tissue, fat free mass , water content in the body) subjected to bioelectrical impedancy analysis - Tanita 780.

    Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)

    Measured: Second examination - at the end of the three-week program

  21. Ranges of motion in the joints of the upper limb

    with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  22. Ranges of motion in the joints of the upper limb

    with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

    Measured: First examination - before the start of the rehabilitation program

  23. Ranges of motion in the joints of the upper limb

    with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

    Measured: Second examination - at the end of the three-week program

  24. EMG of the extensors and flexors of the joints in the upper limb

    EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

    Measured: research among healthy people, during studies from the 3rd to the 5th year of studies

  25. EMG of the extensors and flexors of the joints in the upper limb

    EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

    Measured: First examination - before the start of the rehabilitation program

  26. EMG of the extensors and flexors of the joints in the upper limb

    EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

    Measured: Second examination - at the end of the three-week program

Secondary outcomes (38)
  1. 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"

    Measured: First examination - before the start of the rehabilitation program

  2. 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"

    Measured: Second examination - at the end of the three-week program

  3. Balance was assessed using Berg Balance Scale (BBS)

    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

    Measured: First examination - before the start of the rehabilitation program

  4. Balance was assessed using Berg Balance Scale (BBS)

    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

    Measured: Second examination - at the end of the three-week program

  5. 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

    1. 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
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

    Measured: First examination - before the start of the rehabilitation program

  6. 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

    1. 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
    2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
    3. Considerable increase in muscle tone, passive movement difficult
    4. Affected part(s) rigid in flexion or extension

    Measured: Second examination - at the end of the three-week program

  7. 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

    Measured: First examination - before the start of the rehabilitation program

  8. 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

    Measured: Second examination - at the end of the three-week program

  9. 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 (0-6): _______

    Measured: First examination - before the start of the rehabilitation program

  10. 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 (0-6): _______

    Measured: Second examination - at the end of the three-week program

  11. 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.

    Measured: First examination - before the start of the rehabilitation program

  12. 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.

    Measured: Second examination - at the end of the three-week program

  13. Handgrip function, according Franchay 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.

    Measured: First examination - before the start of the rehabilitation program

  14. Handgrip function, according Franchay 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.

    Measured: Second examination - at the end of the three-week program

  15. Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

    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

    1. - task partially completed,
    2. - task completed correctly The higher the score, the better.

    Measured: First examination - before the start of the rehabilitation program

  16. Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

    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

    1. - task partially completed,
    2. - task completed correctly The higher the score, the better.

    Measured: Second examination - at the end of the three-week program

  17. Gross Motor Function Classification System (GMFCS)

    the GMFCS is a 5-step assessment system for functioning and mobility in daily life.

    Measured: First examination - before the start of the rehabilitation program

  18. Gross Motor Function Classification System (GMFCS)

    the GMFCS is a 5-step assessment system for functioning and mobility in daily life.

    Measured: Second examination - at the end of the three-week program

  19. Manual Ability Classification System (MACS)

    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.

    Measured: First examination - before the start of the rehabilitation program

  20. Manual Ability Classification System (MACS)

    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.

    Measured: Second examination - at the end of the three-week program

  21. Changes in blood parameter: HDL

    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.

    Measured: First examination - before the start of the rehabilitation program

  22. Changes in blood parameter: HDL

    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.

    Measured: Second examination - at the end of the three-week program

  23. Changes in blood parameter: LDL

    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

    Measured: First examination - before the start of the rehabilitation program

  24. Changes in blood parameter: LDL

    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

    Measured: Second examination - at the end of the three-week program

  25. Changes in blood parameter: total cholesterol

    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

    Measured: First examination - before the start of the rehabilitation program

  26. Changes in blood parameter: total cholesterol

    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

    Measured: Second examination - at the end of the three-week program

  27. Assessment of WHR

    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.

    Measured: First examination - before the start of the rehabilitation program

  28. Assessment of WHR

    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.

    Measured: Second examination - at the end of the three-week program

  29. Assessment of metabolic syndrome

    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

    Measured: First examination - before the start of the rehabilitation program

  30. Assessment of metabolic syndrome

    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

    Measured: Second examination - at the end of the three-week program

  31. Changes in blood parameter: TG

    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

    Measured: First examination - before the start of the rehabilitation program

  32. Changes in blood parameter: TG

    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

    Measured: Second examination - at the end of the three-week program

  33. Changes in blood parameter: atherogenic index

    Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.

    atherogenic index level

    • in men below 4.5 (below 3.5 after myocardial infarction)
    • in women below 4.0 (below 3.0 after myocardial infarction)

    Measured: First examination - before the start of the rehabilitation program

  34. Changes in blood parameter: atherogenic index

    Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.

    atherogenic index level

    • in men below 4.5 (below 3.5 after myocardial infarction)
    • in women below 4.0 (below 3.0 after myocardial infarction)

    Measured: Second examination - at the end of the three-week program

  35. Changes in blood parameter: CRP

    Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.

    CRP level:

    • CRP below 5 mg / l (up to 10 mg / l - in obese people with hypertension) norm
    • CRP above 40 mg / l - may indicate a mild viral infection or pregnancy;
    • CRP above 200 mg / l - bacterial inflammation develops in the body;
    • CRP above 500 mg / l - takes place in the situation of very serious infections with basic and bacterial infections and burns.

    Measured: First examination - before the start of the rehabilitation program

  36. Changes in blood parameter: CRP

    Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.

    CRP level:

    • CRP below 5 mg / l (up to 10 mg / l - in obese people with hypertension) norm
    • CRP above 40 mg / l - may indicate a mild viral infection or pregnancy;
    • CRP above 200 mg / l - bacterial inflammation develops in the body;
    • CRP above 500 mg / l - takes place in the situation of very serious infections with basic and bacterial infections and burns.

    Measured: Second examination - at the end of the three-week program

  37. Changes in blood parameter: serum glucose

    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

    Measured: First examination - before the start of the rehabilitation program

  38. Changes in blood parameter: serum glucose

    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

    Measured: Second examination - at the end of the three-week program

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2022
  2. Study start1 Aug 2022
  3. Primary completion30 Jan 2023
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prior to the study, an assessment of the reliability, reproducibility and validity of the instrument will be conducted among healthy individuals followed by random selection into two groups (study group and control group)
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05486052
Sponsor's protocol ID
neurological rehabilitation
Status last verified
Apr 2024
First submitted
18 Jul 2022
Last updated
17 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Leszczak J, Pniak B, Gazda G, Guzik A. Assessment of the effects of rehabilitation of hand function using a biometrics device in people after stroke - a randomized controlled trial. Front Neurol. 2025 Sep 16;16:1643336. doi: 10.3389/fneur.2025.1643336. eCollection 2025.

    PubMed 41036275

Questions about this trial

What is this clinical trial studying?

A study testing Evaluation of reliability, repeatability and validity of devices among healthy subjects and Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training in people with Rehabilitation and Biofeedback, run by University of Rzeszow at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

assessment of prioprioception (deep sensation) (time frame: research among healthy people, during studies from the 3rd to the 5th year of studies). The study lists 26 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05486052, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.

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