Biofeedback-enhanced rehabilitation for people recovering from stroke

Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke

This project will test whether adding biofeedback exercises with Biometrics E-link or Stella Bio devices to a standard three-week inpatient spa rehabilitation helps people aged 45–80 recovering from a late-stage stroke improve hand and arm function.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 45 Years to 80 Years
• Sex: All
• Sponsor: University of Rzeszow (other)
• Locations: 1 site (Rzeszów)
• Trial ID: NCT07333079 on ClinicalTrials.gov

What this trial studies

Participants are randomized to one of three groups: conventional rehabilitation plus biofeedback with the Biometrics E-link device, conventional rehabilitation plus biofeedback with the Stella Bio device, or a standard spa rehabilitation program without biofeedback. Rehabilitation is delivered as continuous inpatient care over three weeks at a rehabilitation spa, with assessments at admission, at discharge, and at a three-month follow-up visit. Outcomes include hand muscle strength, grip function, dexterity (Box and Blocks), proprioception tests, Ashworth spasticity score, Barthel Index/ADL measures, BMI, and other rehabilitation outcome scales. Sociodemographic data are collected at baseline and the trial compares change in motor and functional measures across the three groups.

Who should consider this trial

Good fit: Ideal candidates are people aged 45–80 after a first late-stage stroke who have basic gripping ability, upper-limb paresis rated Brunnström 4–5, Rankin disability score of 3, and spasticity no greater than 3 on the modified Ashworth scale.

Not a fit: Patients unlikely to benefit include those with recurrent or hemorrhagic stroke, brainstem or cerebellar strokes, major cognitive or visual-field impairments, severe hand injuries or contractures, or other neurological/orthopedic conditions that prevent participation in exercises.

Why it matters

Potential benefit: If successful, adding biofeedback could improve hand strength, dexterity, and day-to-day function for people after late-stage stroke.

How similar studies have performed: Previous small trials of biofeedback and device-assisted training after stroke have shown mixed but promising improvements in motor control and function, though larger confirmatory trials are still limited.

Eligibility criteria

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

Where this trial is running

Rzeszów

• University of Rzeszów — Rzeszów, Poland (RECRUITING)

Study contacts

• Principal investigator: Justyna Leszczak, PhD — Univeristy of Rzeszów
• Study coordinator: Justyna Leszczak, PhD

Conditions: Rehabilitation, Stroke, Late period in stroke, Health-resort based rehabilitation, Conventional rehabilitation, Modern technologies, Biofeedback