Rehabilitation of Upper Limbs After Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy..
- Who it may be relevant to
- Registry conditions: Rehabilitation, Stroke. Basic parameters: 45 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke
Overview
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.
Detailed description
Prior to the study, an assessment of the reliability, reproducibility and validity of the devices among stroke individuals will be carried out.
The research will be conducted among people who have suffered a stroke in the late period.
The subjects will be allocated, by random selection, to two groups:
The study group will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Pablo Tyromotion device.
The control group will participate in conventional rehabilitation without biofeedback exercises.
Patients will undergo ongoing rehabilitation at the Donum Corde Rehabilitation and Medical Care Center (four weeks). The first examination will be performed on the day of admission, the second on the day of discharge, and the third (control) one month after discharge, during a follow-up visit.
Measurements will be performed three times for all participants:
* assessment of hand and finger muscle strength * 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
Interventions
- Other Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
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.
Primary outcome measures
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: First examination - before the start of the rehabilitation program]
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: Second examination - at the end of the three-week program]
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale [Time frame: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
Secondary outcome measures (12)
- Hand grip strength [Time frame: First examination - before the start of the rehabilitation program]
- Hand grip strength [Time frame: Second examination - at the end of the three-week program]
- Hand grip strength [Time frame: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
- pinching strength of the fingers [Time frame: First examination - before the start of the rehabilitation program]
- pinching strength of the fingers [Time frame: Second examination - at the end of the three-week program]
- pinching strength of the fingers [Time frame: Third study (flow-up) - month after Rehabilitation Center 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. [Time frame: 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. [Time frame: Second examination - at the end of the three-week program]
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points. [Time frame: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
- Manual skills, assessed with Box and Blocks test; [Time frame: First examination - before the start of the rehabilitation program]
- Manual skills, assessed with Box and Blocks test; [Time frame: Second examination - at the end of the three-week program]
- Manual skills, assessed with Box and Blocks test; [Time frame: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- University of Rzeszów — Rzeszów
Identifiers
NCT: NCT07450274 · Neurorehabilitation upper limb