- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Jade He, PhD
- Номер телефона: 64431 (650) 493-5000
- Электронная почта: Jade.He@va.gov
Места учебы
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California
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Palo Alto, California, Соединенные Штаты, 94304-1207
- Рекрутинг
- VA Palo Alto Health Care System, Palo Alto, CA
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Контакт:
- Jade He, PhD
- Номер телефона: 64431 650-493-5000
- Электронная почта: Jade.He@va.gov
-
Главный следователь:
- Jade He, PhD
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
|---|
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Knee flexion angle
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Knee flexion moment
Временное ограничение: Baseline and Week 1
|
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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (Transformed)
Временное ограничение: Baseline and Week 1
|
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
Временное ограничение: Baseline or Week 1
|
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
Временное ограничение: Baseline or Week 1
|
The number of repetitions of chair-to-stand performed during 30-second
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Baseline or Week 1
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Соавторы и исследователи
Следователи
- Главный следователь: Jade He, PhD, VA Palo Alto Health Care System, Palo Alto, CA
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RRD8-005-24W
- 66791 (Другой идентификатор: Stanford IRB)
- IK1RD000707 (Грант/контракт NIH США)
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .