- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07507552
뇌졸중 생존자의 상지 운동학에 대한 PETTLEP 기반 AOMI의 즉각적 효과
PETTLEP 기반 AOMI가 뇌졸중 생존자의 상지 운동역학에 미치는 즉각적 효과: 무작위 대조 시험.
This study investigates the immediate effects of a single session of Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI) on upper-limb movement quality in chronic stroke survivors. Stroke frequently causes reduced movement smoothness and prompts compensatory strategies such as trunk displacement and shoulder elevation. Participants received a single session of either PETTLEP-based AOMI (watching mirror-reversed self-observation and performing real-time kinesthetic imagery of a functional Reach-Drink-Return task) or a duration- and structure-matched active sham (non-motor nature videos and resonant breathing). A single smartphone camera and MediaPipe Pose Landmarker were utilized to evaluate immediate changes in movement smoothness (NVP and SPARC), path straightness, shoulder elevation, trunk displacement, movement time, and functional performance (WMFT-4).
연구 개요
상태
상세 설명
This study employs a single-blind, pretest-posttest, prospective randomized controlled trial design to evaluate the acute effects of a single session of Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI) in stroke patients. Following a stroke, patients often develop pathological movement patterns and maladaptive compensatory strategies, such as trunk displacement or shoulder girdle elevation, due to impaired motor commands. Traditional task practice requires voluntary motor output that many severely impaired patients lack. Motor imagery combined with action observation offers a cognitive simulation alternative that activates neural motor planning circuits.A total of 28 eligible stroke survivors will be randomized in a 1:1 ratio into an experimental (AOMI) group or a control group. Baseline kinematics of a standardized Reach-to-Drink task will be recorded using MediaPipe, a markerless motion capture system utilizing smartphone cameras.The intervention lasts approximately 13 minutes in total. The experimental group will engage in a scaffolded AOMI protocol. This includes action observation (watching a 1st-person video of the task) and selective motor imagery with specific constraints targeting movement smoothness and the inhibition of compensatory trunk and shoulder movements. The control group will perform matched-duration non-motor mental tasks, focusing on forming mental images that contain no movement, such as calm natural scenes, colors, or light. They will be explicitly instructed to avoid imagining any upper-extremity movements. Immediately following the intervention, the reach-to-drink task will be re-assessed using the MediaPipe system to quantify short-term changes in movement smoothness (Number of Velocity Peaks and Spectral Arc Length - SPARC), trunk displacement, and shoulder girdle elevation.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Istanbul, 터키 (Türkiye)
- Neurorehabilitation Clinic, Istinye University Liv Bahçeşehir Hospital
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Istanbul, 터키 (Türkiye)
- Physical Medicine and Rehabilitation Outpatient Clinic, Biruni University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female and male adults aged 40 to 80 years with a diagnosis of unilateral ischemic or hemorrhagic stroke.
- A first-ever unilateral ischemic or hemorrhagic stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI), or recurrent stroke that left no residual motor deficit from the earlier strokes.
- Mild to moderate spasticity (Modified Ashworth Scale ≤ 2).
- Medically stable patients, with no active or uncontrolled systemic illness.
- Ability to sit unsupported for at least 30 minutes and be able to perform brief cognitive-motor exercises.
- Able to perform the brief cognitive-motor exercises included in the protocol.
- Medical Research Council (MRC) muscle strength grade of 3 or higher.
Exclusion Criteria:
- Other central nervous system disorders (e.g., Parkinson's disease, multiple sclerosis, traumatic brain injury).
- Musculoskeletal or orthopedic conditions causing restriction of movement in the upper-limb (such as fixed contractures, severe joint deformities, shoulder subluxation).
- Moderate or severe sensory loss (NIHSS sensory score ≥ 2), or moderate or severe neglect (NIHSS extinction/inattention score ≥ 2).
- Uncontrolled seizures, severe cardiovascular instability, or any other contraindication to imagery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Experimental Group: PETTLEP-based AOMI
Participants will receive a single 13-minute session of a scaffolded AOMI protocol. The session includes a preparation phase involving sensory transfer using the unaffected arm, action observation of a 1st-person video, and selective motor imagery with smoothness and trunk control constraints. No physical execution of the task is performed during the intervention. |
A mental practice protocol involving sensory preparation (using the unaffected arm to transfer sensation), action observation, and motor imagery of a reach-to-drink task with selective functional constraints targeting movement smoothness, trunk stability, and shoulder control. |
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가짜 비교기: Control Group: Cognitive and Somatic Control
A duration-matched 13-minute session comprising non-motor nature footage (beach, forest, waterfall) paired with scene imagery, followed by paced resonant slow breathing (6 breaths/min) using an expanding/contracting visual circle, containing no upper-limb motor content. |
Structured non-motor mental tasks, including attention to breathing and calm mental imagery (e.g., natural scenes or colors), timed to match the experimental intervention and explicitly designed to engage attention without any motor system participation. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Movement Smoothness (Number of Velocity Peaks)
기간: Immediately before and after the 13-minute intervention session.
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Movement smoothness of the affected upper extremity will be quantified as the total Number of Velocity Peaks (NVP) by MediaPipe. Lower NVP values indicate a more continuous movement. |
Immediately before and after the 13-minute intervention session.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Movement Smoothness (Spectral Arc Length - SPARC)
기간: Immediately before and after the 13-minute intervention session.
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A secondary measure of smoothness calculated using Spectral Arc Length (SPARC) across different phases of the task by MediaPipe. Higher SPARC values indicate smoother movement. |
Immediately before and after the 13-minute intervention session.
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Path Straightness
기간: Immediately before and after the 13-minute intervention session.
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Evaluated as a ratio (0-1) during the reach and reach-to-drink phases. It is calculated by dividing the straight-line distance between the start and end of the wrist path by the total path length travelled. Values closer to 1.0 indicate a straighter, more efficient goal-directed movement path. |
Immediately before and after the 13-minute intervention session.
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Trunk Displacement (Compensatory Strategy)
기간: Immediately before and after the 13-minute intervention session.
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Measured in centimeters (cm) as the maximum anterior horizontal shift of the midpoint between the shoulders in the direction of hand travel from lift onset to the highest wrist point, converted using a participant-specific body-based scale factor. Larger values indicate greater compensatory trunk movement. |
Immediately before and after the 13-minute intervention session.
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Shoulder Girdle Elevation (Compensatory Strategy)
기간: Immediately before and after the 13-minute intervention session.
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Measured in centimeters (cm) as the maximum upward vertical displacement of the affected shoulder in the image plane after lift onset (following median smoothing over a 9-frame window). Larger values reflect greater compensatory shoulder hitching during upper-limb movement. |
Immediately before and after the 13-minute intervention session.
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Upper-Extremity Function (Wolf Motor Function Test, Short Form - WMFT-4)
기간: Immediately before and after the 13-minute intervention session.
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Upper-extremity functional performance will be assessed using the four-item short form of the Wolf Motor Function Test (WMFT-4). Completion time and functional performance scores will be recorded for each item. |
Immediately before and after the 13-minute intervention session.
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Movement Imagery Ability (Kinesthetic and Visual Imagery Questionnaire-10 - KVIQ-10)
기간: Immediately before and after the 13-minute intervention session.
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Evaluates visual and kinesthetic movement-imagery capacity. The visual and kinesthetic subscale scores are summed separately; each ranges from 5 to 25, and the total score ranges from 10 to 50. Higher scores signify greater vividness of imagery. |
Immediately before and after the 13-minute intervention session.
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Pain - Visual Analog Scale (VAS)
기간: Immediately before and immediately after the 25-minute intervention session.
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Participants indicate their pain intensity by placing a mark on a 10-cm horizontal line. The left side is labeled "no pain" (0) and the right side is labeled "worst pain imaginable". |
Immediately before and immediately after the 25-minute intervention session.
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Visual Analog Mood Scale - 4 dimensions (VAMS-4)
기간: Immediately before and after the 13-minute intervention session.
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Evaluates immediate changes in mood state across four dimensions (happy, sad, calm, and tense). Participants rate how they feel at the moment on a 0-10 scale (0 = not at all, 10 = extremely) to control for non-specific emotional responses to the intervention. |
Immediately before and after the 13-minute intervention session.
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Motor Difference Rating Scale (MDRS)
기간: Immediately before and after the 13-minute intervention session.
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A two-item 0-10 self-report scale assessing perceived motor control. Before the intervention, participants rate how well they can control the muscles of the affected arm (0 = no control, 10 = full normal control); immediately after, they rate how much difference they feel in muscle control resulting from the session. |
Immediately before and after the 13-minute intervention session.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Begüm Kara Kaya, Asst. Prof, Istinye University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
- 2026/56
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Individual participant data (IPD) will not be shared to ensure the strict privacy and confidentiality of the stroke survivors participating in this study. The data collected involves specific clinical and kinematic assessments conducted for an academic Master's thesis. The informed consent obtained from participants covers the use of their data for this specific research project and allows for publication in aggregate form only. It does not explicitly grant permission for open public data sharing. Therefore, only summary and aggregate data will be reported in the final thesis and any resulting peer-reviewed publications.
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미국 FDA 규제 기기 제품 연구
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