Rehabilitation of Upper Limbs After Stroke

NCT07450274 | Recruiting

• 1 other identifier: Neurorehabilitation upper limb
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the research will be to evaluate the effects of upper limb rehabilitation using modern Pablo Tyromotion technologies in people after stroke in the late period.

Conditions

Rehabilitation; Stroke

Keywords

upper limb; hand; rehabilitation; biofeedback; modern technologies

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) - month after Rehabilitation Center discharge, during a follow-up visit

Secondary Outcomes (21)

• 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) - month after Rehabilitation Center discharge, during a follow-up visit

• pinching strength of the fingers

  First examination - before the start of the rehabilitation program

• pinching strength of the fingers

  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)

Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among stroke

NO INTERVENTION

Evaluation of reliability, repeatability and validity of device Pablo Tyromotion among stroke. Prior to the study among individuals with stroke, an evaluation of the reliability, repeatability and credibility of the Pablo Tyromotion to be included in the biofeedback rehabilitation. The evaluation of the Pablo Tyromotion will be carried out by two independent researchers twice.

Study group using Pablo Tyromotion

EXPERIMENTAL

Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. In the control group, patients will complete a 3.5-hour daily rehabilitation program. The program will include two hours of individual therapy with a physiotherapist, one hour of verticalization, and 30 minutes of exercises on the Pablo Tyromotion device.

Other: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.

Control group

NO INTERVENTION

In the control group, patients will complete a 3.5-hour daily rehabilitation program. The program will include two hours of individual therapy with a physiotherapist, one hour of verticalization, and 30 minutes of upper limb exercises.

Interventions

Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. OTHER

Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. The rehabilitation program will last 4 weeks from Monday to Friday.

Study group using Pablo Tyromotion

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
• Donum Corde Rehabilitation Center: collaborator

Study Sites (1)

University of Rzeszów

Rzeszów, 35-205, Poland

RECRUITING

MeSH Terms

Conditions

Stroke

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 K 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: Before starting the study, the reliability, repeatability and validity of the Pablo Tyromotion device will be assessed among people after stroke, followed by random selection into two groups (research group and control group).

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

PL (1)