Knee OsteoarthritisUPPFR-KneeOANCT06882928
Applications of Ultrasound and Physical Parameters in Assessing Fall Risk in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Ultrasound Exams, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
Trial summary
Falls are a significant issue for patients with knee osteoarthritis, as they can lead to hospitalization or even more severe consequences. Therefore, it is crucial to assess fall risk early in rehabilitation clinics. Sarcopenia, which is the reduction of muscle mass, increases the risk of falls. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis, Ultrasound Exams, Fall Risk
- How many people
- 250 participants
- Where
- 1 siteTaiwan
- Study dates
- 24 Mar 2025to 31 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants eligible for the study include males and females aged 60 and above who are willing to sign an informed consent form, have a clinically confirmed diagnosis of knee osteoarthritis, have received at least one treatment in the outpatient rehabilitation department during the study period, and can walk independently, even with the use of assistive devices.
Who may be able to join
- Males and females aged 60 and above, who are willing to sign an informed consent form.
- Participants must have a clinically confirmed diagnosis of knee osteoarthritis.
- Participants must have received at least one treatment in the outpatient rehabilitation department during the study period.
- Participants must be able to walk independently, even with the aid of assistive devices.
Who cannot join
- Individuals who have undergone lower limb surgery or have significant lower limb deformities.
- Individuals with severe cognitive impairment who are unable to understand or comply with the study procedures.
- Individuals who cannot communicate in a language understandable by the research team.
- Individuals with severe comorbidities that affect assessment or treatment (e.g., unable to safely complete assessments or treatments).
- Individuals planning to undergo knee surgery during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Applications of Ultrasound and Physical Parameters in Assessing Fall Risk Among Patients With Knee Osteoarthritis: A Prospective Cohort Study
Falls are a significant issue for patients with knee osteoarthritis, as they can lead to hospitalization or even more severe consequences. Therefore, it is crucial to assess fall risk early in rehabilitation clinics. Sarcopenia, which is the reduction of muscle mass, increases the risk of falls. This study involved 250 adults with knee osteoarthritis, using a technology called POCUS to assess muscle mass, combined with other tests to track fall incidents over three months. The study is expected to find correlations between falls and factors like muscle mass and grip strength. This information can help doctors better predict which patients are at risk of falling and take preventive measures early. Future research will explore the effectiveness of different prevention strategies.
Read the detailed description
Background
Falls represent a significant health issue for patients with knee osteoarthritis, potentially leading to hospitalization, disability, or even death. Early screening for fall risk in rehabilitation clinics is crucial; however, challenges arise due to time constraints and individual differences among patients. Sarcopenia, characterized by a reduction in muscle mass, is closely associated with an increased risk of falls, and point-of-care ultrasound (POCUS) offers a non-invasive and effective tool for assessing muscle mass.
Methods
This prospective study involved 250 adults with knee osteoarthritis attending the orthopedic physical therapy outpatient department at National Taiwan University Hospital. POCUS technology was utilized to evaluate muscle mass, complemented by grip strength tests, lower limb strength assessments, self-reported fall risk questionnaires, sarcopenia assessments, get-up-and-go tests, thirty-second sit-to-stand tests, general nutrition screening for malnutrition, and bioimpedance analysis. A three-month follow-up study was conducted to monitor fall incidents.
Expected Results
During the three-month follow-up, it is anticipated that a certain proportion of participants will experience fall incidents. Significant correlations are expected to be identified between fall incidents and various measurements, including muscle mass assessed by POCUS, grip strength, lower limb strength, self-reported fall risk scores, sarcopenia assessments, get-up-and-go tests, thirty-second sit-to-stand tests, the geriatric nutritional risk index, and bioimpedance analysis. Differences between the fall group and the non-fall group on these variables will also be statistically significant, indicating that the combination of POCUS technology and other clinical assessment indicators enhances the predictive ability regarding fall risk in patients with knee osteoarthritis.
Future Clinical Applications
The integration of POCUS technology with other clinical assessment indicators may be applied in rehabilitation outpatient settings to screen for fall risk in adults with knee osteoarthritis, facilitating early intervention and prevention. Future research will investigate the effectiveness of various intervention strategies.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| knee osteoarthritis | Males and females aged 60 and above must have a clinically confirmed diagnosis of knee osteoarthritis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fall Incident Tracking
Participants will be monitored for fall incidents over a three-month period, and the accuracy of the model predictions will be analyzed.
Measured: Three-month period
Secondary outcomes (10)
Grip strength testing
Measures the maximum strength of hand and forearm muscles using a hand dynamometer. It reflects overall muscle function and the ability to perform daily tasks. Results are reported in kilograms or pounds.
Measured: Baseline grip strength
POCUS Assessment
Point-of-care ultrasound is used to measure participants' muscle mass
Measured: Baseline POCUS Assessment
Sarcopenia Risk Assessment Questionnaire (SARC-F)
An assessment tool designed to determine the risk of sarcopenia in individuals. Scale: The SARC-F consists of five questions scored from 0 to 10, with higher scores indicating a greater risk of sarcopenia.
Measured: Baseline Sarcopenia Risk Assessment Questionnaire (SARC-F)
Bioelectrical Impedance Analysis (BIA) Measurement
Conduct bioelectrical impedance measurements to assess body composition, including fat mass and lean body mass.
Unit of Measure: Results are typically presented in kilograms and percentage for fat mass and lean body mass.
Measured: Baseline BIA measurement
Knee extension strength testing
Assesses the strength of the quadriceps by measuring the force exerted during knee extension against resistance, helping evaluate functional mobility. Results can be quantified as force or estimated one-repetition maximum.
Measured: Baseline knee extension strength testing
Timed Up and Go (TUG) Test
Evaluates mobility and balance by timing how long it takes a participant to rise from a chair, walk three meters, turn, and sit down. Longer times suggest a higher fall risk, especially in older adults.
Measured: Baseline Timed Up and Go (TUG) Test
30-Second Sit-to-Stand Test
Counts how many times a participant can stand from sitting in 30 seconds. It assesses lower body strength and endurance, with higher counts indicating better functional ability.
Measured: Baseline 30-Second Sit-to-Stand Test
Falls Efficacy Scale-International (FES-I)
A scale that measures the concern about falling during daily activities. Scale: The FES-I includes 16 items scored from 16 to 64, where higher scores indicate greater concern about falling.
Measured: Baseline Falls Efficacy Scale-International (FES-I)
Body weight measurement
Measure the body weight of participants using a calibrated scale. Unit of Measure: Kilograms or pounds.
Measured: Baseline body weight measurement
Height Measurement
Record the participant's height using a stadiometer. Unit of Measure: Meters or centimeters.
Measured: Baseline height measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start24 Mar 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- National Taiwan University Clinical Trial Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06882928
- Sponsor's protocol ID
- 202501047RINA
- Acronym
- UPPFR-KneeOA
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Ultrasound and Physical Parameters in Assessing Fall Risk Among Patients With Knee Osteoarthritis: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06882928
- Acronym / sponsor ID
- UPPFR-KneeOA / 202501047RINA
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- National Taiwan University Clinical Trial CenterUniversity, hospital or other
- Study start
- 24 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Mar 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.
Falls are a significant issue for patients with knee osteoarthritis, as they can lead to hospitalization or even more severe consequences. Therefore, it is crucial to assess fall risk early in rehabilitation clinics. Sarcopenia, which is the reduction of muscle mass, increases the risk of falls. This study involved 250 adults with knee osteoarthritis, using a technology called POCUS to assess muscle mass, combined with other tests to track fall incidents over three months. The study is expected to find correlations between falls and factors like muscle mass and grip strength. This information can help doctors better predict which patients are at risk of falling and take preventive measures early. Future research will explore the effectiveness of different prevention strategies.
Detailed description
Background
Falls represent a significant health issue for patients with knee osteoarthritis, potentially leading to hospitalization, disability, or even death. Early screening for fall risk in rehabilitation clinics is crucial; however, challenges arise due to time constraints and individual differences among patients. Sarcopenia, characterized by a reduction in muscle mass, is closely associated with an increased risk of falls, and point-of-care ultrasound (POCUS) offers a non-invasive and effective tool for assessing muscle mass.
Methods
This prospective study involved 250 adults with knee osteoarthritis attending the orthopedic physical therapy outpatient department at National Taiwan University Hospital. POCUS technology was utilized to evaluate muscle mass, complemented by grip strength tests, lower limb strength assessments, self-reported fall risk questionnaires, sarcopenia assessments, get-up-and-go tests, thirty-second sit-to-stand tests, general nutrition screening for malnutrition, and bioimpedance analysis. A three-month follow-up study was conducted to monitor fall incidents.
Expected Results
During the three-month follow-up, it is anticipated that a certain proportion of participants will experience fall incidents. Significant correlations are expected to be identified between fall incidents and various measurements, including muscle mass assessed by POCUS, grip strength, lower limb strength, self-reported fall risk scores, sarcopenia assessments, get-up-and-go tests, thirty-second sit-to-stand tests, the geriatric nutritional risk index, and bioimpedance analysis. Differences between the fall group and the non-fall group on these variables will also be statistically significant, indicating that the combination of POCUS technology and other clinical assessment indicators enhances the predictive ability regarding fall risk in patients with knee osteoarthritis.
Future Clinical Applications
The integration of POCUS technology with other clinical assessment indicators may be applied in rehabilitation outpatient settings to screen for fall risk in adults with knee osteoarthritis, facilitating early intervention and prevention. Future research will investigate the effectiveness of various intervention strategies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| knee osteoarthritis | – | –Males and females aged 60 and above must have a clinically confirmed diagnosis of knee osteoarthritis. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants eligible for the study include males and females aged 60 and above who are willing to sign an informed consent form, have a clinically confirmed diagnosis of knee osteoarthritis, have received at least one treatment in the outpatient rehabilitation department during the study period, and can walk independently, even with the use of assistive devices.
Key inclusion criteria (4 listed)
- Males and females aged 60 and above, who are willing to sign an informed consent form.
- Participants must have a clinically confirmed diagnosis of knee osteoarthritis.
- Participants must have received at least one treatment in the outpatient rehabilitation department during the study period.
- Participants must be able to walk independently, even with the aid of assistive devices.
Key exclusion criteria (5 listed)
- Individuals who have undergone lower limb surgery or have significant lower limb deformities.
- Individuals with severe cognitive impairment who are unable to understand or comply with the study procedures.
- Individuals who cannot communicate in a language understandable by the research team.
- Individuals with severe comorbidities that affect assessment or treatment (e.g., unable to safely complete assessments or treatments).
- Individuals planning to undergo knee surgery during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fall Incident Tracking
Time frame: Three-month period
Participants will be monitored for fall incidents over a three-month period, and the accuracy of the model predictions will be analyzed.
10 secondary outcomes
Grip strength testing
Time frame: Baseline grip strength
POCUS Assessment
Time frame: Baseline POCUS Assessment
Sarcopenia Risk Assessment Questionnaire (SARC-F)
Time frame: Baseline Sarcopenia Risk Assessment Questionnaire (SARC-F)
Bioelectrical Impedance Analysis (BIA) Measurement
Time frame: Baseline BIA measurement
Knee extension strength testing
Time frame: Baseline knee extension strength testing
Timed Up and Go (TUG) Test
Time frame: Baseline Timed Up and Go (TUG) Test
30-Second Sit-to-Stand Test
Time frame: Baseline 30-Second Sit-to-Stand Test
Falls Efficacy Scale-International (FES-I)
Time frame: Baseline Falls Efficacy Scale-International (FES-I)
Body weight measurement
Time frame: Baseline body weight measurement
Height Measurement
Time frame: Baseline height measurement
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 19 Mar 2025.
- Individual participant dataSharing planned: Yes
Related trials for Knee Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
RecruitingObservational study
Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
Knee Osteoarthritis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Ultrasound Exams, run by National Taiwan University Clinical Trial Center at 1 site in Taiwan.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 Chih-Chin Lai (886-988630906, b94408040@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fall Incident Tracking (time frame: Three-month period). 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 19 Mar 2025.