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

NCT07212920 | Not Yet Recruiting

• 1 other identifier: PTassessment_digital_knee
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Is a function-based knee assessment without specific knee tests valid compared to traditional in-person diagnostics using specific tests?
2. 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. 3.What is the interrater agreement of function-based knee assessments conducted via video compared to those conducted in person?

Conditions

Knee Pain

Keywords

Physiotherapy; Physical therapy; Assessment; Diagnosis; Digital care; Telemedicine; Knee pain; Anterior cruciate ligament; Knee osteoarthritis; Meniscus tears; Collateral ligament

Outcome Measures

Primary Outcomes (4)

• Number of Participants with Agreement in Diagnostic Categories from Functional In-Person Assessment

  Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across in-person assessments with or without specific tests - functional assessment compared to traditional assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.

  Day 1

• Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History

  Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across digital assessment with only patient history compared with traditional in person assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.

  Day 1

• Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History and Functional Evaluation

  Primary outcome is whether the system-level diagnosis (diagnostic category) assigned by the physiotherapist matches across digital assessment with traditional in person assessment with specific tests. Diagnoses are categorized into five predefined groups: ligament, meniscus, joint-related, soft tissue, and other. Within each category, physiotherapists assign specific ICD-10 codes. Outcome is measured as match/mismatch between diagnostic categories.

  Day 1

• Number of participants with agreement in test results of functional assessment

  Primary outcome is whether the test results from the functional tests performed in the video consultation differs from in-person functional assessment.

  Day 1

Secondary Outcomes (15)

• Degree of diagnostic certainty

  Day 1

• Number of Participants with Agreement on Specific Diagnostic Categories

  Day 1

• Patient-Rated Satisfaction With the Assessment

  Day 1

• Adverse events

  Day 1

• Number of Participants Requiring Additional Specific Knee Tests Following Assessment

  Day 1

Other Outcomes (3)

• Demographic data

  At baseline before physiotherapy assessment

• Knee Pain Intensity Measured by Numeric Rating Scale (NRS)

  At baseline before physiotherapy assessment

• Knee Injury and Osteoarthritis Outcome Score - 12 Items (KOOS-12)

  At baseline before physiotherapy assessment

Study Arms (1)

Digital assessment first, then face-to-face

EXPERIMENTAL

Participants undergo two knee assessments: one video-based and one in-person. The video-based exam includes standardized history taking and functional tests without specific knee tests, conducted via clinic software with the physiotherapist in a separate room. The in-person exam follows immediately and includes the same functional tests plus specific knee tests (e.g., ligament, meniscus). After each part, physiotherapists assess whether sufficient information is available to proceed with treatment. All assessments follow standardized protocols, pilot-tested by physiotherapists. Data collection occurs at a public rehab clinic in Västra Götaland, with physiotherapists trained prior to study start.

Diagnostic Test: Physiotherapy digital assessment; Diagnostic Test: Physiotherapy assessment - only functional tests

Interventions

Physiotherapy digital assessment DIAGNOSTIC_TEST

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 participant in separate rooms. Physiotherapists provide diagnostic judgments after each assessment phase. All procedures follow standardized protocols, pilot-tested and conducted at a public rehabilitation clinic in Västra Götaland.

Digital assessment first, then face-to-face

Physiotherapy assessment - only functional tests DIAGNOSTIC_TEST

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). Physiotherapists provide diagnostic judgments after each assessment phase. All procedures follow standardized protocols, pilot-tested and conducted at a public rehabilitation clinic in Västra Götaland.

Digital assessment first, then face-to-face

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Disease; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Chan-Mei Ho-Henriksson, PhD in Medical Sciences

CONTACT

+460700-82 58 72; chan-mei.ho@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: October 8, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Start: After ethical approval. Anticipated date: October 1st. End: Available as long as R\&D Project Database in Region Västra Götaland is available.
• Access Criteria: Individual participant data (IPD) will be provided if the request complies with GDPR and Swedish data protection regulations. The following study documents will be shared publicly on a Swedish platform R\&D Project Database in Region Västra Götaland and can be translated if requested: Study Protocol, Statistical Analysis Plan (SAP), and Informed Consent Form (ICF).