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Набор скоро начнётся NCT07212920

Validity and Reliability of Video-Based Functional Physiotherapy Assessment of Subacute Knee Injuries

Без фазы С лечением Knee Pain

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Physiotherapy digital assessment, Physiotherapy assessment - only functional tests.
Кому может быть актуально
Состояния в реестре: Knee Pain. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Physiotherapeutic Function-Based Assessment and Diagnosis of Subacute Knee Injuries During Physical or Video-Based Consultations - A Validity and Reliability Study

Обзор

This study aims to validate a function-based physiotherapy assessment for subacute knee pain without using specific knee tests. Assessments are conducted either in-person or via video consultations in primary care. The study also compares the reliability of digital versus physical assessments to determine if video-based evaluations can provide sufficient diagnostic support and guide treatment decisions. The main questions this study aims to answer are: 1. Is a function-based knee assessment without specific knee tests valid compared to traditional in-person diagnostics using specific tests? 2. Is a video-based assessment based on history and function-based knee assessment without specific knee tests as valid and reliable as an in-person function-based knee assessment? 3. What is the interrater agreement of function-based knee assessments conducted via video compared to those conducted in person?

Подробное описание

BACKGROUND Knee pain is one of the most common complaints in primary care. Traditional knee assessments include history-taking, evaluation of joint mobility and muscle strength, and specific tests targeting structures such as ligaments and menisci. However, functional tests-such as chair rise or single-leg stance-evaluate the integrated performance of multiple structures and may be more feasible in digital consultations.

Existing literature shows variable validity for specific knee tests, with only a few reaching acceptable thresholds for sensitivity and specificity. In video-based assessments, joint mobility evaluation is reliable, and functional tests are recommended over strength tests. While some knee tests are suggested for digital use, their measurement properties as self-administered tests under physiotherapist supervision remain unclear.

This study will investigate whether a function-based assessment without specific knee tests can provide sufficient diagnostic information and guide treatment decisions for subacute knee injuries. It will also compare the validity and reliability of digital versus in-person physiotherapy assessments in primary care.

METHODS Participants will be consecutively recruited from public and private rehabilitation clinics in the Västra Götaland region of Sweden. Individuals with subacute knee pain (onset between 1 week and 3 months) will be informed about the study through clinics, websites, and online booking systems. Interested individuals will complete a digital screening form to assess eligibility. Those who meet the inclusion criteria will receive written study information and will be able to provide informed consent digitally via Bank-ID.

Demographic data will be collected through the same form, including age, gender, origin, symptom experience, pain intensity and duration, prior video consultation experience, perceived balance, and estimated travel distance to the clinic. This information will support analysis of environmental and accessibility factors.

Eligible participants will be contacted to schedule two knee assessments-one in-person and one via video. Each visit is expected to last approximately 30 minutes, with additional time allocated for preparation and documentation by the physiotherapists.

Inclusion criteria will include age ≥18, subacute knee symptoms, ability to bear weight and flex the knee, no tenderness over patella or fibula, sufficient Swedish language skills, and access to digital technology.

Exclusion criteria will include prior assessment for current symptoms, recent knee or hip surgery, and inability to walk independently.

Sample size calculations indicate that at least 22 participants per diagnostic category (total n=110) will be needed to detect a kappa coefficient of 0.60. With an estimated 20% dropout rate, the target sample size will be 138. Recruitment will continue until minimum group sizes are met or for up to one year.

The study will evaluate the validity and reliability of function-based knee assessments without specific tests, comparing in-person and video-based formats.

Participants will undergo two consecutive knee assessments at a rehabilitation clinic. The first will be a video-based evaluation, including history-taking and functional tests, conducted in real time with the physiotherapist in a separate room. The second will be a traditional in-person assessment, including both functional and specific knee tests. Physiotherapists will use standardized protocols and receive training prior to data collection.

Data collection Participant background data (e.g., age, gender, pain intensity, duration, prior video visit experience, and travel distance) will be collected via a secure web form after consent. Each participant will undergo two knee assessments-first via video, then in person-conducted by the same physiotherapist. Diagnostic agreement between methods will be evaluated, along with physiotherapist confidence and patient satisfaction. Standardized tools include NRS for pain and KOOS-12 for function and quality of life. Secondary outcomes include adverse events, need for further testing or referral, and time required per visit.

Statistical Analysis:

Descriptive statistics will include means, medians, standard deviations, and quartiles. The in-person assessment with specific knee tests will serve as the gold standard. Diagnostic agreement between methods will be analyzed using Cohen's kappa, which will also be used to assess intra-rater agreement. Sensitivity and specificity will be calculated to evaluate the accuracy of assessments without specific tests. Confidence intervals for kappa values will be reported.

Differences in diagnostic certainty level will be analyzed using paired t-test if the data is normally distributed, and wilcoxon signed-rank test if using non-parametric test.

Вмешательства

  • Диагностический тест Physiotherapy digital assessment
    This study involves three types of knee assessments to evaluate diagnostic reliability and validity: (1) a video-based function-based examination without specific knee tests, (2) traditional in-person function-based examination without specific knee tests and to control with (3) a traditional in-person examination including specific knee tests. The video-based assessment includes standardized history taking and functional evaluation conducted via clinic software, with the physiotherapist and par
  • Диагностический тест Physiotherapy assessment - only functional tests
    This study involves three types of knee assessments to evaluate diagnostic reliability and validity: (1) a video-based function-based examination without specific knee tests, (2) traditional in-person function-based examination without specific knee tests and to control with (3) a traditional in-person examination including specific knee tests. The in-person assessments (2 and 3) includes the same functional tests plus specific tests targeting knee structures (ligaments, meniscus etc). Physiothe

Первичные конечные точки

  • Number of Participants with Agreement in Diagnostic Categories from Functional In-Person Assessment [Срок оценки: Day 1]
  • Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History [Срок оценки: Day 1]
  • Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History and Functional Evaluation [Срок оценки: Day 1]
  • Number of participants with agreement in test results of functional assessment [Срок оценки: Day 1]
Вторичные конечные точки (12)
  • Degree of diagnostic certainty [Срок оценки: Day 1]
  • Number of Participants with Agreement on Specific Diagnostic Categories [Срок оценки: Day 1]
  • Patient-Rated Satisfaction With the Assessment [Срок оценки: Day 1]
  • Adverse events [Срок оценки: Day 1]
  • Number of Participants Requiring Additional Specific Knee Tests Following Assessment [Срок оценки: Day 1]
  • Number of Participants Requiring Supplementary In-Person Examinations After Video-Based Assessment [Срок оценки: Day 1]
  • Number of Participants Referred to a Physician Following Assessment [Срок оценки: Day 1]
  • Time required for each visit [Срок оценки: Day 1]
  • Reliability of 30 seconds chair stand test [Срок оценки: Day 1]
  • Reliability of Joint Mobility Assessment [Срок оценки: Day 1]
  • Reliability of Sit-to-Stand Ability From Chair [Срок оценки: Day 1]
  • Reliability of Lunge Performance [Срок оценки: Day 1]

Критерии участия

Критерии включения

  • Age 18 years or older
  • Subacute knee symptoms (onset more than one week ago but less than three months ago)
  • Fulfillment of Ottawa Knee Rule criteria to exclude fractures:

A) Able to bear weight for at least four steps both immediately after injury and at the time of assessment (limping allowed) B) Able to flex the knee to 90 degrees C) No tenderness over the fibular head or patella

  • Sufficient proficiency in written and spoken Swedish to complete forms and describe symptoms; no need for interpreter
  • Access to digital technology (e.g., computer or smartphone)

Критерии исключения

  • Prior assessment for current knee symptoms (by rehab clinic, physician, emergency care, or urgent care)
  • Knee or hip replacement surgery within the past year
  • Other knee surgeries (ACL, meniscus, ligament) within the past year
  • Inability to walk independently, with or without walking aids

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07212920 · PTassessment_digital_knee

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗