Rehabilitation With Biofeedback for People After Stroke

NCT07333079 | Recruiting

• 1 other identifier: Stroke rehabilitation
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rehabilitation; Stroke

Keywords

Rehabilitation; Late period in stroke; Health-resort based rehabilitation; Conventional (traditional) rehabilitation; Modern technologies; Biofeedback

Outcome Measures

Primary Outcomes (3)

• Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

  It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

  First examination - before the start of the rehabilitation program

• Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

  It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

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

• Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale

  It consists of 33 items assessing motor function and reflexes. The patient can score a maximum of 66 points, where each item on the scale is rated as: 0=unable, 1=partially able, or 2=fully able to perform the movement

  Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

Secondary Outcomes (18)

• Hand grip strength

  First examination - before the start of the rehabilitation program

• Hand grip strength

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

• Hand grip strength

  Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit

• 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

Other Outcomes (4)

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

  First examination - before the start of the rehabilitation program

• Assessment of disability level, using the modified Rankin scale (MRS)

  First examination - before the start of the rehabilitation program

• Assessment of paretic limb function was assessed using the Brunnström scale

  First examination - before the start of the rehabilitation program

Study Arms (3)

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

EXPERIMENTAL

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.

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

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.

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

Health-resort based rehabilitation.

NO INTERVENTION

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

Interventions

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

Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).

Group I-Biofeedback method using the Biometrics E-link device and Health-resort based rehabilitation; Group II -Biofeedback method using the Stella Bio device and Health-resort based rehabilitation.

Eligibility Criteria

• Age: 45 Years - 80 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 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

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
• failure to complete a 3-week rehabilitation stay

Sponsors & Collaborators

• University of Rzeszow: lead

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Justyna Leszczak, PhD

  Univeristy of Rzeszów

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justyna Leszczak, PhD

CONTACT

+48721581801; jleszczak@ur.edu.pl

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: Random selection into groups (study group I, study group II and control group).

Study Record Dates

• First Submitted: December 27, 2025
• First Posted: January 12, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

PL (1)