Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Rehabilitation
- Sponsor
- University of Rzeszow
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Ranges of motion in the joints of the upper limb
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Justyna Leszczak
Principal Investigator
University of Rzeszow
Eligibility Criteria
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;
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
Outcomes
Primary Outcomes
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.
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
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: 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
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.
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
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,
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: Second examination - at the end of the three-week program
Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)
Secondary Outcomes
- 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)
- Assessment of disability level, using the modified Rankin scale (MRS)(Second examination - at the end of the three-week program)
- Changes in blood parameter: atherogenic index(Second examination - at the end of the three-week program)
- Changes in blood parameter: total cholesterol(Second examination - at the end of the three-week program)
- Balance was assessed using Berg Balance Scale (BBS)(Second examination - at the end of the three-week program)
- Manual skills, assessed with Box and Blocks test;(Second examination - at the end of the three-week program)
- Handgrip function, according Franchay scale(Second examination - at the end of the three-week program)
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale(Second examination - at the end of the three-week program)
- Changes in blood parameter: LDL(Second examination - at the end of the three-week program)
- Assessment of metabolic syndrome(Second examination - at the end of the three-week program)
- Changes in blood parameter: serum glucose(Second examination - at the end of the three-week program)
- Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.(Second examination - at the end of the three-week program)
- Assessment of paretic limb function was assessed using the Brunnström scale.(Second examination - at the end of the three-week program)
- Assessment of WHR(Second examination - at the end of the three-week program)
- Changes in blood parameter: TG(Second examination - at the end of the three-week program)
- Gross Motor Function Classification System (GMFCS)(Second examination - at the end of the three-week program)
- Changes in blood parameter: HDL(Second examination - at the end of the three-week program)
- Manual Ability Classification System (MACS)(Second examination - at the end of the three-week program)
- Changes in blood parameter: CRP(Second examination - at the end of the three-week program)