- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07631182
Action Observation Therapy in Chronic Stroke Via Telerehabilitation
Investigation of the Effect of Action Observation Therapy Via Telerehabilitation Method on Upper Extremity Functions, Daily Living Activities and Quality of Life in Chronic Stroke Patients
연구 개요
상세 설명
Stroke is defined as a neurological condition caused by focal damage to the central nervous system due to vascular problems such as cerebral infarction, intracerebral or subarachnoid hemorrhage. Stroke is among the leading causes of death and disability worldwide.
Functional impairment in the upper extremities is frequently observed in stroke patients, significantly limiting their grasping and releasing functions, and consequently their daily living activities (ADL) such as eating, drinking, dressing, and self-care. Due to these limitations, stroke patients become dependent to varying degrees, negatively impacting their quality of life. Scientists are conducting various studies to find effective, low-cost, and easily applicable methods that can reduce the effects of stroke, which imposes a significant economic, physical, social, and psychological burden on patients and their families, and improve recovery.
Action Observation Therapy (AOT), which involves observing simple actions frequently used in ADL and then imitating those observed actions, is a rehabilitation approach applied in clinical settings in recent years to improve upper extremity function in the rehabilitation of stroke and various neurological diseases. The neural basis of AOT is the mirror neuron system, which is active not only when observing one's own movements but also when observing others' movements. Studies using Functional Magnetic Resonance Imaging have shown that mirror neuron activity increases when observing the movements of others. It is stated that observing an action and then trying to imitate it reduces interhemispheric inhibition, and as a result, it activates the primary motor cortex that causes the observed movement, facilitates the execution of the action, eliminates motor function disorders, and allows for the relearning of functions.
Telerehabilitation is the remote delivery of rehabilitation services through telecommunication technology. Telerehabilitation increases the accessibility of physiotherapy interventions in situations where face-to-face rehabilitation is not possible or difficult to access. In stroke patients with a lengthy rehabilitation process, telerehabilitation offers significant advantages, including reduced difficulties in transferring the patient to the healthcare center, shorter travel time, reduced transportation costs, and lower energy costs.
A literature review revealed no studies comparing the effects of AOT delivered via telerehabilitation on upper extremity function, hand skills, daily living activities, and quality of life in patients with chronic stroke compared with conventional physiotherapy.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Mustafa KAVAK, Phd
- 전화번호: +905065089564
- 이메일: mustafakavak@karabuk.edu.tr
연구 장소
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Merkez
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Karabük, Merkez, 터키 (Türkiye), 78100
- 모병
- Karabuk University
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연락하다:
- Mustafa KAVAK
- 전화번호: 05065089564
- 이메일: mustafakavak@karabuk.edu.tr
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Karabük, Merkez, 터키 (Türkiye), 78100
- 모병
- Mustafa KAVAK
-
부수사관:
- Elif Ulukan, PT
-
연락하다:
- Mustafa KAVAK, Phd
- 전화번호: +905065089564
- 이메일: mustafakavak@karabuk.edu.tr
-
부수사관:
- Cihan Caner Aksoy, Assoc. Professor
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부수사관:
- Musa Güneş, Phd
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부수사관:
- İlker İlhanlı, Professor
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Being over 18 years of age,
- Diagnosis of left hemiparetic stroke,
- Having passed between 6 months since the onset of stroke,
- Being in stage 4 or 5 of the hand and stage 4, 5 or 6 of the upper extremity according to Brunnstrom staging,
- Being able to sit on a chair for 30 minutes without support (patients who scored 20 or more points in total from the Trunk Impairment Scale),
- Scoring 24 or more points from the Mini Mental Test
Exclusion Criteria:
- Unwillingness to participate in the study,
- Having spasticity that prevents grasping and releasing an object (levels 3 and 4 on the Modified Ashworth Scale),
- Having a contracture in any of the affected upper extremity joints,
- Having severe neglect disorder (scoring 21 or higher on the Catherine Bergego Scale),
- Having impaired cooperation, compliance, and behavior during the administration of tests used to obtain data,
- Having a mental impairment that prevents communication and following basic commands (scoring less than 24 on the Mini-Mental Test),
- Having additional neurological and/or orthopedic problems that may affect motor performance and sitting balance,
- Having severe visual and hearing problems (if any, these problems not corrected with assistive devices such as glasses, contact lenses, hearing aids, etc.)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Action observation Therapy
Participants will receive AOT via telerehabilitation in addition to conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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All participants will receive conventional physiotherapy, including stretching, strengthening, core mobility, balance, electrotherapy, and endurance exercises in the clinic.
These traditional sessions will be administered by physiotherapists three times a week, each lasting 45 minutes.
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간섭 없음: control
Participants will receive only conventional physiotherapy.
They will receive 3 sessions per week for 5 weeks.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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경련
기간: 기준선
|
수정 된 Ashworth 스케일을 사용하여 경련이 평가됩니다.
점수가 증가함에 따라 경련이 증가합니다.
이 척도의 최소 점수는 1이고 최대 점수는 5입니다.
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기준선
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혈액의 단계
기간: 기준선
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"Brunnstrom Hemiplegia Recovery Steging"은 환자의 혈액 단계를 결정하는 데 사용됩니다.
이 척도는 1과 6 사이에서 점수가 매겨집니다.
점수가 증가함에 따라 환자는 향상됩니다.
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기준선
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지배적 인면
기간: 기준선
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"Edinburgh Hand Preference Test"는 일상 생활에서 환자가 사용하는 지배적 측면을 결정하는 데 사용됩니다.
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기준선
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Cognitif 기능
기간: 기준선
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미니 정신 검사는인지 기능을 평가하는 데 사용됩니다.
평가에서, 24-30 포인트는인지 기능이 정상임을 나타냅니다. 18-23 점은 가벼운인지 장애를 나타내고, 17 점 이하는인지 상태가 심각하게 영향을 받음을 나타냅니다.
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기준선
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소홀히 하다
기간: 기준선
|
Catherine Bergego 척도는 일상 생활 활동에 대한 뇌졸중 후 일방적 인 방치의 영향을 평가하는 데 사용됩니다.
1-10은 가벼운 방치, 11-20은 중간 정도의 방치를 나타내고 21-30은 심각한 방치를 나타냅니다.
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기준선
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Motor function
기간: Baseline, five week later (after intervention)
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The "Fugl-Meyer Upper Extremity Motor Assessment Scale" will be used to evaluate upper extremity motor functions.
This scale ranges from 0 to 66 points.
As the score increases, motor function improves.
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Baseline, five week later (after intervention)
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Upper extremity function
기간: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions (hand-arm) and motor speed will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent for the test increases.
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Baseline, five week later (after intervention)
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Functional Independence
기간: Baseline, five week later (after intervention)
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Evaluation of upper extremity functions will be done with the "Nine-Hole Peg Test".
Function decreases as the time spent on the test increases.
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Baseline, five week later (after intervention)
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Life Quality
기간: Baseline, five week later (after intervention)
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The Stroke Specific Quality of Life Scale will be used to assess the quality of life of individuals with stroke.
The higher the total score, the better the quality of life of the individual with stroke.
This scale is scored between 49-245.As the score increases, the quality of life increases.
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Baseline, five week later (after intervention)
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Mancuso M, Tondo SD, Costantini E, Damora A, Sale P, Abbruzzese L. Action Observation Therapy for Upper Limb Recovery in Patients with Stroke: A Randomized Controlled Pilot Study. Brain Sci. 2021 Feb 26;11(3):290. doi: 10.3390/brainsci11030290.
- Shamili A, Hassani Mehraban A, Azad A, Raissi GR, Shati M. Effects of Meaningful Action Observation Therapy on Occupational Performance, Upper Limb Function, and Corticospinal Excitability Poststroke: A Double-Blind Randomized Control Trial. Neural Plast. 2022 Sep 16;2022:5284044. doi: 10.1155/2022/5284044. eCollection 2022.
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Karabuk-02
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
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