Rehabilitation, Stroke
Conditions
Keywords
Rehabilitation, Late period in stroke, Health-resort based rehabilitation, Conventional (traditional) rehabilitation, Modern technologies, Biofeedback
Brief summary
The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
Detailed description
Study participants will be randomly assigned to a study group and a control group. * Study group I - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Biometrics E-link device * Study group II - will complete a conventional rehabilitation program supplemented with biofeedback exercises using the Stella Bio device * Control group - will complete a standard spa rehabilitation program without biofeedback exercises. The study participants will be patients admitted to the Spa and Rehabilitation Hospital in Iwonicz-Zdrój, Poland, after a late-stage stroke. Patients will undergo continuous inpatient rehabilitation (3 weeks). The first examination will be conducted on the day of hospital admission, the second on the day of discharge, and the third (follow-up) 3 months after hospital discharge, during a follow-up visit. Prior to the study, a socio-demographic questionnaire will be administered, including questions about education, marital status, and place of residence. Measurements will be performed three times for all participants: * hand muscle strength assessment * 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
OTHERBiofeedback method using the Biometrics E-link (group I) and Stella Bio (group II) devices.
Patients in study groups I and II will also receive 30 minutes daily of hand biofeedback training using the Biometrics E-link device (group I) and hand biofeedback training using the Stella Bio device (group II).
Sponsors
University of Rzeszow
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Random selection into groups (study group I, study group II and control group).
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand grip strength | First examination - before the start of the rehabilitation program | measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg, |
| 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 | Activities of daily living were assessed using Barthel Index. The subjects could score the maximum of 100 points. A maximum of 100 points can be obtained on the Barthel scale. There are three assessment ranges: getting from 0 to 20 points. means total dependence, from 20 to 80 points. means that to some extent the patient needs help from others, and the assessment in the border is 80 to 100 points. means that with a little help the patient can function alone. 0-20 points patient's condition "light" 21-85 points - "medium-heavy" patient condition 86-100 points - patient condition "very heavy" |
| Manual skills, assessed with Box and Blocks test; | First examination - before the start of the rehabilitation program | The test uses a wooden box, divided into two equal parts by a partition, as well as 150 blocks. The subject moves as many blocks as possible from one part of the box to the other during 60 seconds. |
| Assessment of proprioception Thumb Localizing Test (TLT) | First examination - before the start of the rehabilitation program | . Thumb Localizing Test (TLT). (A) positioning of the paretic UE by the examiner. (B) four spaces in which the paretic UE is placed. Distal spaces are not far from the trunk because the reaching limb should be able to reach them without difficulty. (C) rating of positive results. |
| Proprioception was assessed using a mirror tester for elbow flexion and dorsal and palmar flexion of the radiocarpal joint | First examination - before the start of the rehabilitation program | Assessments were performed with eyes closed. Proprioception of the elbow joint was assessed in the 60° elbow flexion position using a plastic Jamar goniometer. The initial fixed axis of the goniometer was set at the lateral epicondyle of the humerus, and the mobile axis was set parallel to the radius, in accordance with the methodology of the study of joint position sensation in the elbow |
| Handgrip function, according Frenchay scale | First examination - before the start of the rehabilitation program | The scale consists of 7 tasks (pass/fail grading); the patient is awarded 1 point for each activity performed successfully, or 0 points for a failure to perform. The maximum score of seven points may be achieved for the performance of the tasks. Higher score corresponds to better manual skills. The scale measures the proximal control of the upper limb and the manual skills. |
Countries
Poland
Contacts
CONTACTJustyna Leszczak, PhD
PRINCIPAL_INVESTIGATORJustyna Leszczak, PhD
Univeristy of Rzeszów
Outcome results
None listed