NCT05486052

Rehabilitation With Biofeedback in Neurology

Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: University of Rzeszow · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Rehabilitation
• Biofeedback
• Neurological Diseases

Interventions

Type	Name	Description
OTHER	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
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.
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

Timeline

• Start date: 2022-08-01
• Primary completion: 2023-01-30
• Completion: 2023-02-28
• First posted: 2022-08-03
• Last updated: 2024-04-17

Locations

1 site across 1 country: Poland