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.
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
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- 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
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- 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.
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.
- Conditions
- Rehabilitation, Biofeedback, Neurological Diseases
- 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 group | Role | What they receive |
|---|---|---|
| Evaluation of reliability, repeatability and validity of devices among healthy subjects | Other | Evaluation 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 rehabilitation | Other | Health-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 rehabilitation | Other | Control 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.
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
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;
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
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
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;
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
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
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;
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
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;
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1.
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: First examination - before the start of the rehabilitation program
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1.
0: No increase in muscle tone
- Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM
- More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
- Considerable increase in muscle tone, passive movement difficult
- Affected part(s) rigid in flexion or extension
Measured: Second examination - at the end of the three-week program
Assessment of paretic limb function was assessed using the Brunnström scale.
Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities
Measured: First examination - before the start of the rehabilitation program
Assessment of paretic limb function was assessed using the Brunnström scale.
Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities
Measured: Second examination - at the end of the three-week program
Assessment of disability level, using the modified Rankin scale (MRS)
Assessment of disability using the modified Rankin scale (MRS)
Score Description 0 - No symptoms at all
1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL (0-6): _______
Measured: First examination - before the start of the rehabilitation program
Assessment of disability level, using the modified Rankin scale (MRS)
Assessment of disability using the modified Rankin scale (MRS)
Score Description 0 - No symptoms at all
1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL (0-6): _______
Measured: 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.
Measured: 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.
Measured: Second examination - at the end of the three-week program
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
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
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
- - task partially completed,
- - task completed correctly The higher the score, the better.
Measured: First examination - before the start of the rehabilitation program
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
- - task partially completed,
- - task completed correctly The higher the score, the better.
Measured: Second examination - at the end of the three-week program
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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.
- First posted3 Aug 2022
- Study start1 Aug 2022
- Primary completion30 Jan 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Rzeszow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justyna Leszczak, University of Rzeszow
- Investigators
- Justyna Leszczak, PhD, Principal investigator, Univeristy of Rzeszów,
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases
- ClinicalTrials.gov ID
- NCT05486052
- Acronym / sponsor ID
- neurological rehabilitation
- Conditions
- Rehabilitation, Biofeedback, Neurological Diseases
- Keywords
- Rehabilitation, Health-resort based rehabilitation, Conventional (traditional) rehabilitation, Lipid profile, Optical oximetry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- University of RzeszowUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- 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)
| Arm | Type | Receives |
|---|---|---|
| Evaluation of reliability, repeatability and validity of devices among healthy subjects | Other | Other: Evaluation of reliability, repeatability and validity of devices among healthy subjectsEvaluation of the reliability, repeatability and credibility of biofeedback-based devices such as Biometrics, Luna EMG, Vectis, Rotor and nIRS among healthy individuals |
| Biofeedback method and Health-resort based rehabilitation | Other | 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 treatments supplemented with biofeedback training |
| Health-resort based rehabilitation | Other | Other: Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.Control group - health-resort based treatments, without biofeedback training. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- lack of informed, voluntary consent of the patient
- metal implants, electronic implants, menstruation in women, epilepsy,
- failure to complete a 3-week rehabilitation stay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of reliability, repeatability and validity of devices among healthy subjectsEvaluation 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 | Other | 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 trainingThe 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. | Other | Biofeedback method and Health-resort based rehabilitation |
| 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 | Other | Biofeedback method and Health-resort based rehabilitation, Health-resort based rehabilitation |
Primary outcome
assessment of prioprioception (deep sensation)
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
assessment of prioprioception (deep sensation)
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
assessment of prioprioception (deep sensation)
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
assessment of muscle tone (spasticity)
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
assessment of muscle tone (spasticity)
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
assessment of muscle tone (spasticity)
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
ranges of movements in the shoulder joint
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
ranges of movements in the shoulder joint
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
ranges of movements in the shoulder joint
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
Hand grip strength
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,
Hand grip strength
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,
pinching strength of the fingers
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.
pinching strength of the fingers
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.
Hand grip strength
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,
pinching strength of the fingers
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.
optical oximetry
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)
optical oximetry
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)
optical oximetry
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)
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.
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
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.
Time frame: Second examination - at the end of the three-week program
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)
Ranges of motion in the joints of the upper limb
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.
Ranges of motion in the joints of the upper limb
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.
Ranges of motion in the joints of the upper limb
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.
EMG of the extensors and flexors of the joints in the upper limb
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
EMG of the extensors and flexors of the joints in the upper limb
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
EMG of the extensors and flexors of the joints in the upper limb
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
38 secondary outcomes
Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.
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.
Time frame: Second examination - at the end of the three-week program
Balance was assessed using Berg Balance Scale (BBS)
Time frame: First examination - before the start of the rehabilitation program
Balance was assessed using Berg Balance Scale (BBS)
Time frame: Second examination - at the end of the three-week program
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
Time frame: First examination - before the start of the rehabilitation program
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
Time frame: Second examination - at the end of the three-week program
Assessment of paretic limb function was assessed using the Brunnström scale.
Time frame: First examination - before the start of the rehabilitation program
Assessment of paretic limb function was assessed using the Brunnström scale.
Time frame: Second examination - at the end of the three-week program
Assessment of disability level, using the modified Rankin scale (MRS)
Time frame: First examination - before the start of the rehabilitation program
Assessment of disability level, using the modified Rankin scale (MRS)
Time frame: Second examination - at the end of the three-week program
Manual skills, assessed with Box and Blocks test;
Time frame: First examination - before the start of the rehabilitation program
Manual skills, assessed with Box and Blocks test;
Time frame: Second examination - at the end of the three-week program
Handgrip function, according Franchay scale
Time frame: First examination - before the start of the rehabilitation program
Handgrip function, according Franchay scale
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
Time frame: First examination - before the start of the rehabilitation program
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Time frame: Second examination - at the end of the three-week program
Gross Motor Function Classification System (GMFCS)
Time frame: First examination - before the start of the rehabilitation program
Gross Motor Function Classification System (GMFCS)
Time frame: Second examination - at the end of the three-week program
Manual Ability Classification System (MACS)
Time frame: First examination - before the start of the rehabilitation program
Manual Ability Classification System (MACS)
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: HDL
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: HDL
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: LDL
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: LDL
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: total cholesterol
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: total cholesterol
Time frame: Second examination - at the end of the three-week program
Assessment of WHR
Time frame: First examination - before the start of the rehabilitation program
Assessment of WHR
Time frame: Second examination - at the end of the three-week program
Assessment of metabolic syndrome
Time frame: First examination - before the start of the rehabilitation program
Assessment of metabolic syndrome
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: TG
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: TG
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: atherogenic index
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: atherogenic index
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: CRP
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: CRP
Time frame: Second examination - at the end of the three-week program
Changes in blood parameter: serum glucose
Time frame: First examination - before the start of the rehabilitation program
Changes in blood parameter: serum glucose
Time frame: Second examination - at the end of the three-week program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 41036275Leszczak 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justyna Leszczak, PhD principal investigator
Univeristy of Rzeszów,
1 site in 1 country: see every site and its status.
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.