Rebuilding arm and hand movement after a stroke using biofeedback technology
Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke
This trial will test whether adding Pablo Tyromotion biofeedback exercises to standard rehabilitation helps people after a stroke improve arm and hand function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 45 Years to 80 Years |
| Sex | All |
| Sponsor | University of Rzeszow Academic / other |
| Locations | 1 site (Rzeszów) |
| Trial ID | NCT07450274 on ClinicalTrials.gov |
What this trial studies
Before participants are enrolled, the study team will test the reliability and validity of the Pablo Tyromotion devices in people after stroke. Eligible participants in the late post-stroke period will be randomly assigned to four weeks of inpatient conventional rehabilitation either with or without supplementary Pablo Tyromotion biofeedback exercises. Clinical measures (muscle strength, spasticity, proprioception, grip and dexterity tests, Barthel Index, and Fugl–Meyer Upper Extremity scores) will be collected at admission, at discharge after four weeks, and at a one-month follow-up. Outcomes will be compared between the biofeedback-supplemented group and the conventional-rehab-only control group to see if the device adds benefit.
Who should consider this trial
Good fit: Adults aged 45–80 in the late post-stroke period with basic gripping ability, moderate upper-limb paresis (Brunnström stage 4–5), Rankin disability level 3, and Ashworth spasticity ≤3 are the intended participants.
Not a fit: People with recurrent or hemorrhagic strokes, brainstem or cerebellar strokes, major cognitive or visual impairments, severe spasticity or contractures, or other neurological/orthopedic conditions that limit hand function are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, using Pablo Tyromotion biofeedback during rehabilitation could improve upper-limb strength, dexterity, and daily functioning after stroke.
How similar studies have performed: Previous studies of robotic and biofeedback-assisted upper-limb rehabilitation have shown mixed but often positive effects on strength and function, so this approach builds on existing, moderately supportive evidence.
Eligibility criteria
Show full inclusion / exclusion 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 K Leszczak, PhD
- Email: jleszczak@ur.edu.pl
- Phone: +48721581801
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.