Rehabilitation With Biofeedback in Neurology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-28

Brief Summary

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The research will aim to evaluate biofeedback rehabilitation and optical oximetry assessment in neurological patients and the influence of blood parameters on the effect of the rehabilitation carried out.

An additional aim will be to evaluate components of body weight, lifestyle, dietary habits, assessment of mental state, quality of life among the study subjects.

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Detailed Description

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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

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Rehabilitation Biofeedback Neurological Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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)

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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

Group Type OTHER

Evaluation of reliability, repeatability and validity of devices among healthy subjects

Intervention Type OTHER

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 training

Group Type OTHER

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

Intervention Type OTHER

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.

Intervention Type 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

Health-resort based rehabilitation

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

Group Type OTHER

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

Intervention Type 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

Interventions

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Evaluation of reliability, repeatability and validity of devices among healthy subjects

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

Intervention Type OTHER

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

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.

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes