Rehabilitation With Biofeedback in Neurology

NCT05486052 | Completed

• 1 other identifier: neurological rehabilitation
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Rehabilitation; Biofeedback; Neurological Diseases

Keywords

Rehabilitation; Health-resort based rehabilitation; Conventional (traditional) rehabilitation; Lipid profile; Optical oximetry

Outcome Measures

Primary Outcomes (26)

• assessment of prioprioception (deep sensation)

  Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

  research among healthy people, during studies from the 3rd to the 5th year of studies

• assessment of prioprioception (deep sensation)

  Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

  First examination - before the start of the rehabilitation program;

• assessment of prioprioception (deep sensation)

  Measurement performed on the Luna EMG device, selected range of motion with eyes closed 60 degrees elbow joint flexion

  Second examination - at the end of the three-week program

• assessment of muscle tone (spasticity)

  measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

  research among healthy people, during studies from the 3rd to the 5th year of studies

• assessment of muscle tone (spasticity)

  measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

  First examination - before the start of the rehabilitation program;

• assessment of muscle tone (spasticity)

  measurement performed on the Luna EMG machine, range of motion from 0 to 90 degrees elbow joint flexion

  Second examination - at the end of the three-week program

• ranges of movements in the shoulder joint

  measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

  research among healthy people, during studies from the 3rd to the 5th year of studies

• ranges of movements in the shoulder joint

  measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

  First examination - before the start of the rehabilitation program;

• ranges of movements in the shoulder joint

  measurements performed on the Vectis , shoulder joint range of motion: flexion to 170, extension to 170

  Second examination - at the end of the three-week program

• Hand grip strength

  measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

  First examination - before the start of the rehabilitation program;

• Hand grip strength

  measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

  Second examination - at the end of the three-week program

• pinching strength of the fingers

  measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

  First examination - before the start of the rehabilitation program

• pinching strength of the fingers

  measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

  Second examination - at the end of the three-week program

• Hand grip strength

  measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg,

  research among healthy people, during studies from the 3rd to the 5th year of studies

• pinching strength of the fingers

  measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg.

  research among healthy people, during studies from the 3rd to the 5th year of studies

• optical oximetry

  measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

  research among healthy people, during studies from the 3rd to the 5th year of studies

• optical oximetry

  measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

  First examination - before the start of the rehabilitation program

• optical oximetry

  measurement performed with nIRS device, ranges: near infrared light (700-1300 nm) for oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb)

  Second examination - at the end of the three-week program

• 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.

  Assessment of body composition (bioelectrical impedancy analysis - Tanita 780) Change from Baseline body composition at 3 weeks between baseline, after the end of protocol treatment

  First examination - before the start of the rehabilitation program

• 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.

  Assessment of body composition (bioelectrical impedancy analysis - Tanita 780)

  Second examination - at the end of the three-week program

• Ranges of motion in the joints of the upper limb

  with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

  research among healthy people, during studies from the 3rd to the 5th year of studies

• Ranges of motion in the joints of the upper limb

  with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

  First examination - before the start of the rehabilitation program

• Ranges of motion in the joints of the upper limb

  with the use of R 500 goniometer; the device operates with an accuracy up to one degree.

  Second examination - at the end of the three-week program

• EMG of the extensors and flexors of the joints in the upper limb

  EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

  research among healthy people, during studies from the 3rd to the 5th year of studies

• EMG of the extensors and flexors of the joints in the upper limb

  EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

  First examination - before the start of the rehabilitation program

• EMG of the extensors and flexors of the joints in the upper limb

  EMG of the extensors and flexors of the upper limb joints - Biometrics and Luna device

  Second examination - at the end of the three-week program

Secondary Outcomes (38)

• Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.

  First examination - before the start of the rehabilitation program

• 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

• Balance was assessed using Berg Balance Scale (BBS)

  First examination - before the start of the rehabilitation program

• Balance was assessed using Berg Balance Scale (BBS)

  Second examination - at the end of the three-week program

• Assessment of muscle tone (spasticity) was examined with modified Ashworth scale.

  First examination - before the start of the rehabilitation program

Study Arms (3)

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

OTHER

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

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

Biofeedback method and Health-resort based rehabilitation

OTHER

Health-resort based treatments supplemented with biofeedback training

Other: Biofeedback method and Health-resort based rehabilitation Health-resort based treatments supplemented with biofeedback training; Other: Health-resort based rehabilitation Control group - health-resort based treatments, without biofeedback training.

Health-resort based rehabilitation

OTHER

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

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

Interventions

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

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

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

Biofeedback method and Health-resort based rehabilitation

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

Biofeedback method and Health-resort based rehabilitation; Health-resort based rehabilitation

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

Location

Related Publications (1)

• Leszczak J, Pniak B, Gazda G, Guzik A. Assessment of the effects of rehabilitation of hand function using a biometrics device in people after stroke - a randomized controlled trial. Front Neurol. 2025 Sep 16;16:1643336. doi: 10.3389/fneur.2025.1643336. eCollection 2025.

  PMID: 41036275 DERIVED

Study Officials

• Justyna Leszczak, PhD

  Univeristy of Rzeszów,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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)

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: August 3, 2022
• Study Start: August 1, 2022
• Primary Completion: January 30, 2023
• Study Completion: February 28, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Locations

PL (1)