University of Rzeszów
Rzeszów, 35-205, Poland
Location status: Recruiting
NCT Number: NCT07333079
The aim of the research will be to evaluate rehabilitation using the biofeedback method in people after stroke.
Interested in participating?
Request Info45 year–80 year
All sexes
Interventional
Not applicable
Rzeszów, 35-205, Poland
Location status: Recruiting
Study participants will be randomly assigned to a study group and a control group.
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:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
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
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
Time frame: Third study (flow-up) - 3 months after hospital 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
Time frame: 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,
Time frame: Second examination - at the end of the three-week program
measurements to be performed with a dynamometer The dynamometer registers strength
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
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 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"
Time frame: Second examination - at the end of the three-week 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"
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
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"
Time frame: 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.
Time frame: Second examination - at the end of the three-week 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.
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
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.
Time frame: 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.
Time frame: Second examination - at the end of the three-week 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.
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
. 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.
Time frame: 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
Time frame: Second examination - at the end of the three-week 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
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
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
Time frame: 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.
Time frame: Second examination - at the end of the three-week 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.
Time frame: Third study (flow-up) - 3 months after hospital discharge, during a follow-up visit
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.
Time frame: First examination - before the start of the rehabilitation program
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 program]
Time frame: First examination - before the start of the rehabilitation program
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 (0-6):
Time frame: First examination - before the start of the rehabilitation program
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 program
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)
Contact information is provided by the study sponsor or research team.
University of Rzeszow
Other
Evaluation of the Effectiveness of Biofeedback Rehabilitation in People After Stroke
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07525713
Attention, Brain Diseases
Tainan, Taiwan
View Trial DetailsNCT07034521
Brain Diseases, Cardiovascular Diseases
Taipei, Taiwan
View Trial DetailsNCT07139379
Brain Diseases, Cardiovascular Diseases
Tainan, Taiwan
View Trial DetailsNCT05591040
Brain Diseases, Cardiovascular Diseases
Venice-Lido, Italy
View Trial Details