Rehabilitation With Biofeedback in Neurology

Not Applicable

Completed

• Conditions: Rehabilitation; Biofeedback; Neurological Diseases
• Interventions: Other: Evaluation of reliability, repeatability and validity of devices among healthy subjects; 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.

• Registration Number: NCT05486052
• Lead Sponsor: University of Rzeszow

Brief 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.

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 Timeline

• Study First Submitted: 2022-07-18
• Study Start: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Primary Completion: 2023-01-30
• Study Completion: 2023-02-28
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

• 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

Test persons:

• after a stroke;
• Craniocerebral trauma;
• Multiple sclerosis;
• Cerebral Palsy;
• Parkinson's disease
• Total or partial spinal cord injury

Exclusion Criteria

• 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
  • unstable medical condition

• metal implants, electronic implants, menstruation in women, epilepsy,

• failure to complete a 3-week rehabilitation stay

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Evaluation of reliability, repeatability and validity of devices among healthy subjects	Evaluation of reliability, repeatability and validity of devices among healthy subjects	Evaluation 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	Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training	Health-resort based treatments supplemented with biofeedback training
Health-resort based rehabilitation	Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.	Control group - health-resort based treatments, without biofeedback training.
Biofeedback method and Health-resort based rehabilitation	Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.	Health-resort based treatments supplemented with biofeedback training

Primary Outcome Measures

Name	Time	Method
Ranges of motion in the joints of the upper limb	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.
ranges of movements in the shoulder joint	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
assessment of prioprioception (deep sensation)	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)	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
pinching strength of the fingers	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.
EMG of the extensors and flexors of the joints in the upper limb	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
Hand grip strength	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,
optical oximetry	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.	Second examination - at the end of the three-week program	Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)

Secondary Outcome Measures

Name	Time	Method
Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.	Second examination - at the end of the three-week program	Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points.; A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone.; 0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy"
Assessment of disability level, using the modified Rankin scale (MRS)	Second examination - at the end of the three-week program	Assessment of disability using the modified Rankin scale (MRS); Score Description 0 - No symptoms at all; 1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL (0-6): _______
Changes in blood parameter: atherogenic index	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; atherogenic index level; * in men below 4.5 (below 3.5 after myocardial infarction); * in women below 4.0 (below 3.0 after myocardial infarction)
Balance was assessed using Berg Balance Scale (BBS)	Second examination - at the end of the three-week program	Balance was assessed using Berg balance scale (BBS); Berg Balance Scale; Description: 14-item scale designed to measure balance; (1. Sitting to standing 2. Standing unsupported 3. Sitting unsupported 4. Standing to sitting 5. Transfers 6. Standing with eyes closed 7. Standing with feet together 8. Reaching forward with outstretched arm 9. Retrieving object from floor 10. Turning to look behind 11. Turning 360 degrees 12. Placing alternate foot on stool 13. Standing with one foot in front 14. Standing on one foot); Scoring: A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56; Interpretation: 41-56 = independent 21-40 = walking with assistance 0 -20 = wheelchair bound
Manual skills, assessed with Box and Blocks test;	Second examination - at the end of the three-week program	The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds.
Handgrip function, according Franchay scale	Second examination - at the end of the three-week program	The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills.
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale	Second examination - at the end of the three-week program	Fugl-Meyer Motor Assessment Scale for Upper Extremity is a comprehensive tool enabling measurement of motor function; it comprises 33 motor tasks, designed to assess general movements, precision movements, grip, coordination and speed. It is also possible to perform H subgroup tests - assessing superficial and deep sensibility, and J subgroup tests - for range of passive motion and pain induced by such movements.; Individual tasks are assessed on a scale 0-2 0 - impossible task; 1. - task partially completed,; 2. - task completed correctly The higher the score, the better.
Changes in blood parameter: LDL	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; LDL level: Less than 100 mg / dL (2.6 mmol / L) Norm 100 - 129 mg / dL (2.63.34 mmol / L) Above the norm 130 - 159 mg / dL (3.36 - 4.13 mmol / L) Limit 160 - 189 mg / dL (4.14 - 4.90 mmol / L) High 190 mg / dL (4.91 mmol / L) and above Very high
Changes in blood parameter: total cholesterol	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; Total Cholesterol level: Less than 200 mg / dL (5.17 mmol / L) Norm 200 - 239 mg / dL (5.17 - 6.18 mmol / L) Elevated level 240 mg / dL (6.21 mmol / L) High risk of heart disease
Assessment of metabolic syndrome	Second examination - at the end of the three-week program	Metabolic syndrome (polymetabolic syndrome, syndrome X, insulin resistance syndrome, Reaven syndrome) - a set of interrelated factors significantly increasing the risk of atherosclerosis and type 2 diabetes, as well as their vascular complications.; Abdominal (central) obesity; At least three of the following five abnormalities must be identified to formulate a diagnosis: abdominal obesity (waist circumference in men from Europe ≥ 94 cm, and in women ≥ 80 cm) and additionally co-existing two of the following abnormalities: triglycerides ≥ 150 mg/dl or dyslipidaemia related treatment cholesterol HDL \< 40 mg/dl in males \< 50 mg/dl in females or dyslipidaemia related treatment arterial pressure ≥ 130/85 mm Hg or arterial pressure related treatment fasting glycaemia ≥ 100 mg/dl or type 2 diabetes treatment
Changes in blood parameter: serum glucose	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; serum glucose level: From 70 to 99 mg / dL (from 3.9 to 5.5 mmol / L) Normal glucose level From 100 to 125 mg / dL (from 5.6 to 6.9 mmol / L) Abnormal fasting glucose (pre-diabetes) From 126 mg / dL (7.0 mmol / L) Diabetes
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.	Second examination - at the end of the three-week program	Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1.; 0: No increase in muscle tone; 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
Assessment of paretic limb function was assessed using the Brunnström scale.	Second examination - at the end of the three-week program	Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities
Assessment of WHR	Second examination - at the end of the three-week program	The type of obesity is assessed with the so-called waist-to-hip ratio (WHR), which shows the proportion of waist circumference and hip circumference. WHR specifies the location of excessive fat and makes it possible to identify two main types of obesity: visceral obesity (characteristic for men), connected with accumulation of fat in the abdominal cavity and upper part of the body, and gynoid obesity (gluteal-femoral), more common in women.
Changes in blood parameter: TG	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; TG level: Below 150mg / dL (1.69mmol / L) Norm 150 - 199 mg / dL (1.69 - 2.25 mmol / L) Limit 200 - 499 mg / dL (2.26 - 5.63 mmol / L) High Above 500 mg / dL (5.64 mmol / L) Very high
Gross Motor Function Classification System (GMFCS)	Second examination - at the end of the three-week program	the GMFCS is a 5-step assessment system for functioning and mobility in daily life.
Changes in blood parameter: HDL	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; HDL level: Men: Less than 35 mg / dL (0.9 mmol / L) high risk of heart disease.; Women: Lower than 45 mg / dL (1.2 mmol / L) high risk of heart disease. 60 mg / dL (1.56 mmol / L) and above. High HDL cholesterol.
Manual Ability Classification System (MACS)	Second examination - at the end of the three-week program	The Manual Ability Classification System (MACS) describes how children with cerebral palsy use their hands when handling objects in everyday life. The MACS includes five levels. The assignment of a specific level to a child is based on the child's initiated activity during which they use objects, and whether the child needs the help of another person or the adaptation of equipment to be able to use them in everyday activities. The MACS booklet also describes the differences between adjacent levels to make it easier to determine which level best describes the child's ability to use objects.
Changes in blood parameter: CRP	Second examination - at the end of the three-week program	Blood for the tests was drawn from basilic vein by medical personnel at the Rehabilitation Clinic.; CRP level: * 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.

Trial Locations

Locations (1)

University of Rzeszów; 🇵🇱 Rzeszów, Poland