Rehabilitation With Biofeedback for People After Stroke

University of Rzeszow

Status: Enrolling

Conditions: Rehabilitation; Stroke

Treatments: Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

Study type: Interventional

Funder types: Other

Identifiers

NCT07333079

Stroke rehabilitation

Details and patient eligibility

About

The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.

Full description

Study participants will be randomly assigned to a study group and a control group.

• Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device
• Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device
• Control group - will complete a standard spa rehabilitation program without biofeedback exercises.

The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke.

Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit.

Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence.

Measurements will be performed three times for all participants:

• hand muscle strength assessment
• calculated body mass index (BMI)
• proprioceptive testing (mirror test, Thumb Location Test)
• rehabilitation outcome assessment
• functional capacity - Barthel Index, ADL
• Ashworth muscle tone (spasticity)
• hand dexterity using the Box and Blocks test
• hand grip function according to the Frenchay scale
• motor function of the hand and upper limb according to the Fugl-Meyer Motor Assessment Scale for Upper Extremity

Enrollment: 120 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• informed, voluntary consent of the patient
• age 45-80 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

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
• 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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120 participants in 3 patient groups

Group I-Biofeedback method using the Biometrics E-link device and Health-resort based rehabilitation

Experimental group

Description:

The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Biometrics E-link device.

Treatment:

Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

Group II -Biofeedback method using the Stella Bio device and Health-resort based rehabilitation.

Experimental group

Description:

The rehabilitation program will last three weeks, Monday through Friday. Patients will benefit from group and individual exercises (active and assisted exercises, manipulative exercises, PNF-based exercises, balance and breathing exercises), manual massage, and physical treatments such as laser therapy, jacuzzi, mud packs, carbonic acid therapy, TENS therapy, BIO-V lamp, and local cryotherapy. Additionally, patients will receive 30 minutes per day of hand biofeedback training using the Stella Bio device.

Treatment:

Other: Biofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.

Health-resort based rehabilitation.

No Intervention group

Description:

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