뇌졸중 후 상지 재활
뇌졸중 후 환자에게 파블로 티로모션 장비를 이용한 상지 재활 치료 효과 평가
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Rzeszów, 폴란드, 35-205
- University of Rzeszów
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
간섭 없음: 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. |
|
|
실험적: 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. |
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. |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
기간: 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 |
Second examination - at the end of the three-week program
|
|
Motor capacities of the upper limb, according to Fugl-Meyer Motor Assessment Scale
기간: 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 |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hand grip strength
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Hand grip strength
기간: Second examination - at the end of the three-week program
|
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg |
Second examination - at the end of the three-week program
|
|
Hand grip strength
기간: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
measurements to be performed with a dynamometer The dynamometer registers strength lower than up to 90 kg |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
|
pinching strength of the fingers
기간: First examination - before the start of the rehabilitation program
|
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg |
First examination - before the start of the rehabilitation program
|
|
pinching strength of the fingers
기간: Second examination - at the end of the three-week program
|
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg |
Second examination - at the end of the three-week program
|
|
pinching strength of the fingers
기간: Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
measurements to be performed with a pinch meter. The pinch meter registers strength lower than up to 22 kg |
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.
기간: 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" |
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.
기간: 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" |
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.
기간: Third study (flow-up) - month after Rehabilitation Center 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" |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
|
Manual skills, assessed with Box and Blocks test;
기간: 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. |
First examination - before the start of the rehabilitation program
|
|
Manual skills, assessed with Box and Blocks test;
기간: 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. |
Second examination - at the end of the three-week program
|
|
Manual skills, assessed with Box and Blocks test;
기간: Third study (flow-up) - month after Rehabilitation Center 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. |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
|
Assessment of proprioception Thumb Localizing Test (TLT)
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Assessment of proprioception Thumb Localizing Test (TLT)
기간: 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 |
Second examination - at the end of the three-week program
|
|
Assessment of proprioception Thumb Localizing Test (TLT)
기간: Third study (flow-up) - month after Rehabilitation Center 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 |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
|
First examination - before the start of the rehabilitation program
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
First examination - before the start of the rehabilitation program
기간: 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 |
Second examination - at the end of the three-week program
|
|
First examination - before the start of the rehabilitation program
기간: Third study (flow-up) - month after Rehabilitation Center 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 |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
|
Handgrip function, according Frenchay scale
기간: 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. |
First examination - before the start of the rehabilitation program
|
|
Handgrip function, according Frenchay scale
기간: 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. |
Second examination - at the end of the three-week program
|
|
Handgrip function, according Frenchay scale
기간: Third study (flow-up) - month after Rehabilitation Center 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. |
Third study (flow-up) - month after Rehabilitation Center discharge, during a follow-up visit
|
기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessment of muscle tone (spasticity) was examined with modified Ashworth scale
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Assessment of disability level, using the modified Rankin scale (MRS)
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Assessment of paretic limb function was assessed using the Brunnström scale
기간: 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 |
First examination - before the start of the rehabilitation program
|
|
Body mass index (BMI)
기간: 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) |
First examination - before the start of the rehabilitation program
|
공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Justyna Leszczak, PhD, Univeristy of Rzeszów,
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- Neurorehabilitation upper limb
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .