Clinical trial NCT05486052: Rehabilitation With Biofeedback in Neurology
Official title: Evaluation of the Effectiveness of Biofeedback Rehabilitation in Patients With Neurological Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Biofeedback
Neurological Diseases
Keywords: Rehabilitation
Health-resort based rehabilitation
Conventional (traditional) rehabilitation
Lipid profile
Optical oximetry
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 220
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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;
* 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

Primary outcomes:
measure: assessment of prioprioception (deep sensation)
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: assessment of prioprioception (deep sensation)
timeFrame: First examination - before the start of the rehabilitation program;
measure: assessment of prioprioception (deep sensation)
timeFrame: Second examination - at the end of the three-week program
measure: assessment of muscle tone (spasticity)
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: assessment of muscle tone (spasticity)
timeFrame: First examination - before the start of the rehabilitation program;
measure: assessment of muscle tone (spasticity)
timeFrame: Second examination - at the end of the three-week program
measure: ranges of movements in the shoulder joint
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: ranges of movements in the shoulder joint
timeFrame: First examination - before the start of the rehabilitation program;
measure: ranges of movements in the shoulder joint
timeFrame: Second examination - at the end of the three-week program
measure: Hand grip strength
timeFrame: First examination - before the start of the rehabilitation program;
measure: Hand grip strength
timeFrame: Second examination - at the end of the three-week program
measure: pinching strength of the fingers
timeFrame: First examination - before the start of the rehabilitation program
measure: pinching strength of the fingers
timeFrame: Second examination - at the end of the three-week program
measure: Hand grip strength
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: pinching strength of the fingers
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: optical oximetry
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: optical oximetry
timeFrame: First examination - before the start of the rehabilitation program
measure: optical oximetry
timeFrame: Second examination - at the end of the three-week program
measure: 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.
timeFrame: First examination - before the start of the rehabilitation program
measure: 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.
timeFrame: Second examination - at the end of the three-week program
measure: Ranges of motion in the joints of the upper limb
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: Ranges of motion in the joints of the upper limb
timeFrame: First examination - before the start of the rehabilitation program
measure: Ranges of motion in the joints of the upper limb
timeFrame: Second examination - at the end of the three-week program
measure: EMG of the extensors and flexors of the joints in the upper limb
timeFrame: research among healthy people, during studies from the 3rd to the 5th year of studies
measure: EMG of the extensors and flexors of the joints in the upper limb
timeFrame: First examination - before the start of the rehabilitation program
measure: EMG of the extensors and flexors of the joints in the upper limb
timeFrame: Second examination - at the end of the three-week program
Secondary outcomes:
measure: Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.
timeFrame: Second examination - at the end of the three-week program
measure: Balance was assessed using Berg Balance Scale (BBS)
timeFrame: First examination - before the start of the rehabilitation program
measure: Balance was assessed using Berg Balance Scale (BBS)
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of paretic limb function was assessed using the Brunnström scale.
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of paretic limb function was assessed using the Brunnström scale.
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of disability level, using the modified Rankin scale (MRS)
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of disability level, using the modified Rankin scale (MRS)
timeFrame: Second examination - at the end of the three-week program
measure: Manual skills, assessed with Box and Blocks test;
timeFrame: First examination - before the start of the rehabilitation program
measure: Manual skills, assessed with Box and Blocks test;
timeFrame: Second examination - at the end of the three-week program
measure: Handgrip function, according Franchay scale
timeFrame: First examination - before the start of the rehabilitation program
measure: Handgrip function, according Franchay scale
timeFrame: Second examination - at the end of the three-week program
measure: Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
timeFrame: First examination - before the start of the rehabilitation program
measure: Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
timeFrame: Second examination - at the end of the three-week program
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: First examination - before the start of the rehabilitation program
measure: Gross Motor Function Classification System (GMFCS)
timeFrame: Second examination - at the end of the three-week program
measure: Manual Ability Classification System (MACS)
timeFrame: First examination - before the start of the rehabilitation program
measure: Manual Ability Classification System (MACS)
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: HDL
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: HDL
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: LDL
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: LDL
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: total cholesterol
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: total cholesterol
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of WHR
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of WHR
timeFrame: Second examination - at the end of the three-week program
measure: Assessment of metabolic syndrome
timeFrame: First examination - before the start of the rehabilitation program
measure: Assessment of metabolic syndrome
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: TG
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: TG
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: atherogenic index
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: atherogenic index
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: CRP
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: CRP
timeFrame: Second examination - at the end of the three-week program
measure: Changes in blood parameter: serum glucose
timeFrame: First examination - before the start of the rehabilitation program
measure: Changes in blood parameter: serum glucose
timeFrame: Second examination - at the end of the three-week program
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
affiliation: Univeristy of Rzeszów,
name: Justyna Leszczak, PhD
role: PRINCIPAL_INVESTIGATOR
References: