Knee PainNCT07212920
Validity and Reliability of Video-Based Functional Physiotherapy Assessment of Subacute Knee Injuries
A study testing Physiotherapy digital assessment and Physiotherapy assessment - only functional tests in people with Knee Pain, run by Vastra Gotaland Region at 3 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Pain
- What is being tested?
- Physiotherapy digital assessment and Physiotherapy assessment - only functional tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 3 sitesSweden
- Study dates
- 26 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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)
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden3 sites, 3 recruiting
- Recruiting
Närhälsan Sörhaga Rehabmottagning
Alingsås
Oscar Allard, 0322 - 22 62 85 ext. +46, oscar.allard@vgregion.se
- Recruiting
Sportrehab
Gothenburg
Christin Heina, 031 - 15 15 36 ext. +46, christin.heina@vgregion.se
- Recruiting
Närhälsan Lidköping Rehabmottagning
Lidköping, 53151
Chan-Mei Ho-Henriksson, MD, 0700-82 58 72 ext. +46, chan-mei.ho@vgregion.se
About this study
Official title: Physiotherapeutic Function-Based Assessment and Diagnosis of Subacute Knee Injuries During Physical or Video-Based Consultations - A Validity and Reliability Study
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:
- Is a function-based knee assessment without specific knee tests valid compared to traditional in-person diagnostics using specific tests?
- 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?
- What is the interrater agreement of function-based knee assessments conducted via video compared to those conducted in person?
Read the detailed description
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.
- Conditions
- Knee Pain
- Being tested
- Physiotherapy digital assessment, Physiotherapy assessment - only functional tests
- Keywords
- Physiotherapy, Physical therapy, Assessment, Diagnosis, Digital care, Telemedicine, Knee pain, Anterior cruciate ligament, Knee osteoarthritis, Meniscus tears, Collateral ligament
- Medical subject headings
- Disease, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiotherapy digital assessmentDiagnostic 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.
Physiotherapy assessment - only functional testsDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Physiotherapy digital assessment; Diagnostic Test: Physiotherapy assessment - only functional tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1
Secondary outcomes (15)
Degree of diagnostic certainty
After each assessment, the physiotherapists will rate their level of diagnostic certainty on a scale from 0 (not confident) to 100 (fully confident), for a total of four ratings.
- digital patient history assessment B) digital functional assessment C) in-person functional assessment D) in-person specific tests
Measured: Day 1
Number of Participants with Agreement on Specific Diagnostic Categories
The physiotherapists will diagnose with pre-defined ICD-10 diagnoses. All assessments will be compared on a specific diagnostic level.
Measured: Day 1
Patient-Rated Satisfaction With the Assessment
Patient satisfaction will be measured after each knee assessment session using a modified item from the Swedish instrument "Quality from the Patient's Perspective" (QPP). The selected item is: "I received the best possible examination (as far as I can judge myself)." Patients rate their agreement on a 5-point Likert scale: Strongly agree, Mostly agree, Partly agree, Do not agree at all, and Not applicable. The response is collected via a secure web-based form.
Measured: Day 1
Adverse events
Measured: Day 1
Number of Participants Requiring Additional Specific Knee Tests Following Assessment
Measured: Day 1
Number of Participants Requiring Supplementary In-Person Examinations After Video-Based Assessment
Measured: Day 1
Number of Participants Referred to a Physician Following Assessment
Measured: Day 1
Time required for each visit
Measured: Day 1
Reliability of 30 seconds chair stand test
The reliability of testing physical function will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment. Participants perform as many sit-to-stand repetitions as possible within 30 seconds, with arms crossed over the chest. One trial repetition is allowed before the test begins. If unable to perform without assistance, hand support may be used. Each repetition must result in a fully upright standing position, with feet remaining on the floor throughout. The total number of correctly performed repetitions is recorded.
Measured: Day 1
Reliability of Joint Mobility Assessment
The reliability of testing joint mobility will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment.The range of motion is rated using a standardized scale with the following categories:
Impaired Slightly impaired Normal Unable to perform Not assessed
Measured: Day 1
Reliability of Sit-to-Stand Ability From Chair
The reliability of the functional test stand up from sitting will be evaluated by the physiotherapist during each assessment session, video-based compared with in-person assessment. The participant's ability to rise from a chair is assessed using a standardized rating scale:
Impaired Slightly impaired Normal Unable to perform Not assessed
Assessment is based on movement quality, control, and ability to complete the task without assistance. The rating is performed by a physiotherapist during each session.
Measured: Day 1
Reliability of Lunge Performance
The reliability of testing functional performance through forward lunge will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment. The participant's ability to perform a forward lunge is assessed using a standardized rating scale:
Impaired Slightly impaired Normal Unable to perform Not assessed
Assessment is based on movement control, balance, depth, and ability to complete the task without assistance. The rating is performed by a physiotherapist during each session.
Measured: Day 1
Reliability of Single-Leg Squat Performance
The reliability of testing physical performance through single-leg squat will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment. The participant's ability to perform a single-leg squat is assessed using a standardized rating scale:
Impaired Slightly impaired Normal Unable to perform Not assessed
Assessment focuses on movement control, knee alignment, depth, and ability to complete the task without assistance. The rating is performed by a physiotherapist during each session.
Measured: Day 1
Reliability of Sit-to-Stand Ability From Chair
The reliability of testing physical performance through standing up from sitting on a chair will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment. The participant's ability to rise from a chair is assessed using a standardized rating scale:
Impaired Slightly impaired Normal Unable to perform Not assessed
Assessment is based on movement quality, control, and ability to complete the task without assistance. The rating is performed by a physiotherapist during each session.
Measured: Day 1
Reliability of Heel Raise Performance
The reliability of testing physical performance through heel raises will be evaluated by the physiotherapist during each assessment session, video-based assessment compared with in-person assessment. The participant's ability to perform heel raises is assessed using a standardized rating scale:
Impaired Slightly impaired Normal Unable to perform Not assessed
Assessment is based on movement control, range, and ability to complete the task without assistance. The rating is performed by a physiotherapist during each session.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start26 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212920
- Sponsor's protocol ID
- PTassessment_digital_knee
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will not be publicly shared due to restrictions under the EU General Data Protection Regulation (GDPR). However, anonymized data may be made available upon reasonable request, provided 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).
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapeutic Function-Based Assessment and Diagnosis of Subacute Knee Injuries During Physical or Video-Based Consultations - A Validity and Reliability Study
- ClinicalTrials.gov ID
- NCT07212920
- Acronym / sponsor ID
- PTassessment_digital_knee
- Conditions
- Knee Pain
- Keywords
- Physiotherapy, Physical therapy, Assessment, Diagnosis, Digital care, Telemedicine, Knee pain, Anterior cruciate ligament
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 26 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is a function-based knee assessment without specific knee tests valid compared to traditional in-person diagnostics using specific tests?
- 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?
- What is the interrater agreement of function-based knee assessments conducted via video compared to those conducted in person?
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital assessment first, then face-to-face | Experimental | Diagnostic Test: Physiotherapy digital assessment, Diagnostic Test: Physiotherapy assessment - only functional testsParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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:
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiotherapy digital assessmentThis 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. | Diagnostic test | Digital assessment first, then face-to-face |
| Physiotherapy assessment - only functional testsThis 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. | Diagnostic test | Digital assessment first, then face-to-face |
Primary outcome
Number of Participants with Agreement in Diagnostic Categories from Functional In-Person Assessment
Time frame: Day 1
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.
Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History
Time frame: Day 1
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.
Number of Participants with Agreement in Diagnostic Categories - Digital Assessment Based on Patient History and Functional Evaluation
Time frame: Day 1
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.
Number of participants with agreement in test results of functional assessment
Time frame: Day 1
Primary outcome is whether the test results from the functional tests performed in the video consultation differs from in-person functional assessment.
15 secondary outcomes
Degree of diagnostic certainty
Time frame: Day 1
Number of Participants with Agreement on Specific Diagnostic Categories
Time frame: Day 1
Patient-Rated Satisfaction With the Assessment
Time frame: Day 1
Adverse events
Time frame: Day 1
Number of Participants Requiring Additional Specific Knee Tests Following Assessment
Time frame: Day 1
Number of Participants Requiring Supplementary In-Person Examinations After Video-Based Assessment
Time frame: Day 1
Number of Participants Referred to a Physician Following Assessment
Time frame: Day 1
Time required for each visit
Time frame: Day 1
Reliability of 30 seconds chair stand test
Time frame: Day 1
Reliability of Joint Mobility Assessment
Time frame: Day 1
Reliability of Sit-to-Stand Ability From Chair
Time frame: Day 1
Reliability of Lunge Performance
Time frame: Day 1
Reliability of Single-Leg Squat Performance
Time frame: Day 1
Reliability of Sit-to-Stand Ability From Chair
Time frame: Day 1
Reliability of Heel Raise Performance
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will not be publicly shared due to restrictions under the EU General Data Protection Regulation (GDPR). However, anonymized data may be made available upon reasonable request, provided 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy digital assessment and Physiotherapy assessment - only functional tests in people with Knee Pain, run by Vastra Gotaland Region at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chan-Mei Ho-Henriksson, PhD in Medical Sciences (+460700-82 58 72, chan-mei.ho@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Agreement in Diagnostic Categories from Functional In-Person Assessment (time frame: Day 1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.