Rehabilitation With Biofeedback in Neurology

University of Rzeszow

Status: Completed

Conditions: Rehabilitation; Neurological Diseases; Biofeedback

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05486052

neurological rehabilitation

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 3 patient groups

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

Other group

Description:

Evaluation of the reliability, repeatability and credibility of biofeedback-based devices such as Biometrics, Luna EMG, Vectis, Rotor and nIRS among healthy individuals

Treatment:

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

Biofeedback method and Health-resort based rehabilitation

Other group

Description:

Health-resort based treatments supplemented with biofeedback training

Treatment:

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

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

Health-resort based rehabilitation

Other group

Description:

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

Treatment:

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