Evaluation of the Effects of Upper Limb Rehabilitation Using the Pablo Tyromotion Device in People After Stroke
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Rzeszow
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among stroke
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
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.
Intervention: Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy. (Other)
Control group
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.
Outcomes
Primary Outcomes
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
Time Frame: First examination - before the start of the rehabilitation program
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
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
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
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
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
Secondary Outcomes
- 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)
- pinching strength of the fingers(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.(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)
- Assessment of functional status was assessed using the Barthel Index. The subjects could score the maximum of 100 points.(Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit)
- Manual skills, assessed with Box and Blocks test;(First examination - before the start of the rehabilitation program)
- Manual skills, assessed with Box and Blocks test;(Second examination - at the end of the three-week program)
- Manual skills, assessed with Box and Blocks test;(Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit)
- Assessment of proprioception Thumb Localizing Test (TLT)(First examination - before the start of the rehabilitation program)
- Assessment of proprioception Thumb Localizing Test (TLT)(Second examination - at the end of the three-week program)
- Assessment of proprioception Thumb Localizing Test (TLT)(Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit)
- First examination - before the start of the rehabilitation program(First examination - before the start of the rehabilitation program)
- First examination - before the start of the rehabilitation program(Second examination - at the end of the three-week program)
- First examination - before the start of the rehabilitation program(Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit)
- Handgrip function, according Frenchay scale(First examination - before the start of the rehabilitation program)
- Handgrip function, according Frenchay scale(Second examination - at the end of the three-week program)
- Handgrip function, according Frenchay scale(Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit)
Investigators
Justyna Leszczak
Principal Investigator
University of Rzeszow