- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07580222
Mobile Technology to Measure Knee Health in Osteoarthritis
Using Mobile Technology to Extract Mechanical Markers of Joint Health and Function in Early Knee Osteoarthritis
연구 개요
상태
정황
상세 설명
Significance to VA: Veterans, particularly the younger age group, have a higher prevalence of osteoarthritis (OA) than the general population. Among Veterans, OA most commonly affects the knee, a joint with a high injury rate in the US Military. Current diagnostic criteria for knee OA, which often rely on radiographic evidence, do not consistently identify younger patients or those in the early stages of OA, when interventions may be most effective. At the onset of OA symptoms, there is a critical window to quantify mechanical markers that could predict disease progression and provide insights beyond pain. While mechanical markers are predictive and capable of tracking OA progression, their clinical utility has been limited by conventional marker-based motion capture (Mocap), which requires specialized equipment, trained experts, and dedicated resources, making it inaccessible in many clinical settings.
Innovation and Impact: A novel mobile technology, OpenCap, uses smartphone video-based motion capture to estimate movement mechanics, offering a low-cost and highly accessible alternative to traditional Mocap. OpenCap requires at a minimum of two smartphones and applies machine learning and musculoskeletal modeling to quantify mechanical markers. This technology has the potential to overcome significant barriers to implementing mechanical markers in clinical care. However, OpenCap has not yet been evaluated in knee OA patients, and its validity for quantifying mechanical markers during activities relevant to knee OA management remains underexplored.
Therefore, this mentored career development award application has an objective to evaluate the utility of mobile technology OpenCap in quantifying mechanical markers that may provide insights into joint health in patients with early knee OA and to extract these markers from functional activities commonly used in knee OA management.
Specific Aims: Aim 1 will evaluate the current potential use of the mobile technology OpenCap in patients with knee OA by testing the hypotheses that (1a) mechanical markers estimated by the mobile technology significantly differ but are associated with those measured using conventional Mocap and (1b) the mobile technology detects within-person, within-visit mechanical differences introduced by functional activity variations. Aim 2 will explore the broader use of the mobile technology OpenCap in patients with knee OA by (2a) associating mechanical markers estimated by the mobile technology with patient-reported outcomes (PROs), performance-based measures, and structural metrics and (2b) determining the test-retest reliability of the mechanical markers.
Anticipated Research Outcomes: The project findings will have the potential to enable clinicians to trial the technology in its current form, leveraging its potential to quantify and document movement mechanics in patients at risk of or with knee OA. At the same time, the project's results will explore more advanced applications, such as tracking functional changes over time during OA treatment and contributing critical data to refine and further develop the technology. On the other hand, recalling an existing research cohort offers an invaluable opportunity for longitudinal follow-up.
Anticipated Training Outcomes: This award will provide the applicant with training in musculoskeletal modeling, data science, and clinical and translational science, enabling the applicant to validate and refine mobile motion capture technologies. This training will prepare the applicant to integrate mobile technologies into clinical practice and support applicant's advancement to independence through next-level CDA award.
Path to Translation/Implementation: This study will provide clinicians with practical insights on using OpenCap in its current form to quantify and document joint health. Findings will inform future refinements and support subsequent efforts to evaluate the feasibility of video-based motion capture via OpenCap in OA care. This project aligns with VA priorities by improving early diagnosis and management of knee OA to enhance care for Veterans.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jade He, PhD
- 전화번호: 64431 (650) 493-5000
- 이메일: Jade.He@va.gov
연구 장소
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California
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Palo Alto, California, 미국, 94304-1207
- 모병
- VA Palo Alto Health Care System, Palo Alto, CA
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연락하다:
- Jade He, PhD
- 전화번호: 64431 650-493-5000
- 이메일: Jade.He@va.gov
-
수석 연구원:
- Jade He, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Veteran and non-Veterans
- males and females
- diagnosed with early knee osteoarthritis
- qualified for and participated in the Precision Assessment of Platelet Rich Plasma for Joint Preservation study (ClinicalTrials.gov ID: NCT03460236)
- able and willing to provide informed consent for follow-up study
Exclusion Criteria:
- symptomatic OA in joints other than the knee in the lower body
- joint replacement
- rheumatic disease
- BMI > 35 kg/m^2
- severe systematic disease defined as American Society of Anesthesiologists (ASA) 3 or above
- pregnant or intending to become pregnant during the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
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Knee OA
Adults who were previously diagnosed with early knee osteoarthritis, enrolled in Precision Assessment of Platelet Rich Plasma for Joint Preservation study (NCT03460236), and able and willing to participate in the follow-up assessment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee flexion angle
기간: Baseline and Week 1
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Knee flexion angle extracted from functional activities (e.g., walking, chair-to-stand)
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Baseline and Week 1
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee flexion moment
기간: Baseline and Week 1
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Knee flexion moment estimated from functional activities (e.g., walking, chair-to-stand)
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Baseline and Week 1
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (Transformed)
기간: Baseline and Week 1
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores will be calculated from answers to the Knee Injury and Osteoarthritis Outcome Score questionnaire, including domains of Pain, Stiffness, and Function.
WOMAC scores will be transformed to a scale of 0-100, with higher scores indicating fewer symptoms.
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Baseline and Week 1
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Duration of 40-meter fast walk test
기간: Baseline or Week 1
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Duration in seconds to complete 40-meter fast walk test
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Baseline or Week 1
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Repetitions for 30-second chair-to-stand test
기간: Baseline or Week 1
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The number of repetitions of chair-to-stand performed during 30-second
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Baseline or Week 1
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jade He, PhD, VA Palo Alto Health Care System, Palo Alto, CA
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 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. .