Rehabilitation of Upper Limbs After Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorUniversity of Rzeszow
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rehabilitation program using upper limb function training with the Pablo Tyromotion device and conventional physiotherapy.
Other interventionRehabilitation 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Evaluation of reliability, repeatability and validity of devices Pablo Tyromotion among strokeNo intervention 0 interventions
Group B: Study group using Pablo TyromotionExperimental treatment 1 intervention
Group C: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
First examination - before the start of the rehabilitation program2
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
Time frame
Second examination - at the end of the three-week program3
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
Time frame
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visitSecondary outcomes
1
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg
Time frame
First examination - before the start of the rehabilitation program2
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg
Time frame
Second examination - at the end of the three-week program3
Hand grip strength
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg
Time frame
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit4
pinching strength of the fingers
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg
Time frame
First examination - before the start of the rehabilitation programOther outcomes
1
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale
Increased muscle tone (spasticity) was examined with modified Ashworth scale. This is a six-point scale modified to include grade 1. 0: No increase in muscle tone Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved Considerable increase in muscle tone, passive movement difficult Affected part(s) rigid in flexion or extension
Time frame
First examination - before the start of the rehabilitation program2
Assessment of disability level, using the modified Rankin scale (MRS)
Assessment of disability using the modified Rankin scale (MRS) Score Description 0 - No symptoms at all 1- No significant disability despite symptoms; able to carry out all usual duties and activities 2 - Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3 - Moderate disability; requiring some help, but able to walk without assistance 4 - Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5 - Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6 - Dead TOTAL
Time frame
First examination - before the start of the rehabilitation program3
Assessment of paretic limb function was assessed using the Brunnström scale
Motor performance (function) of extremities was assessed using Brunnström scale. This is a six-point scale designed to assess performance (function) of paretic extremities
Time frame
First examination - before the start of the rehabilitation program4
Body mass index (BMI)
WHO BMI classification for adults: \< 18.5 - Underweight (including: \<16.0 starvation, 16.0-16.9 emaciation, 17.0-18.4 underweight) 18.5-24.9 - Normal body weight 25.0-29.9 - Overweight 30.0-34.9 - Class I obesity 35.0-39.9 - Class II obesity (clinical obesity) ≥ 40.0 - Class III obesity (extreme obesity)
Time frame
First examination - before the start of the rehabilitation programSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Rzeszow
Lead sponsor
Donum Corde Rehabilitation Center
Collaborator
Source ClinicalTrials.gov