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Applications of Ultrasound and Physical Parameters in Assessing Fall Risk in Patients With Knee Osteoarthritis

Applications of Ultrasound and Physical Parameters in Assessing Fall Risk Among Patients With Knee Osteoarthritis: A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06882928
Acronym
UPPFR-KneeOA
Enrollment
250
Registered
2025-03-19
Start date
2025-03-24
Completion date
2026-12-31
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fall Risk, Knee Osteoarthritis, Sarcopenia in Elderly, Ultrasound Exams

Brief 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. 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.

Interventions

None listed

Sponsors

National Taiwan University Clinical Trial Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Males and females aged 60 and above, who are willing to sign an informed consent form. 2. Participants must have a clinically confirmed diagnosis of knee osteoarthritis. 3. Participants must have received at least one treatment in the outpatient rehabilitation department during the study period. 4. Participants must be able to walk independently, even with the aid of assistive devices.

Exclusion criteria

1. Individuals who have undergone lower limb surgery or have significant lower limb deformities. 2. Individuals with severe cognitive impairment who are unable to understand or comply with the study procedures. 3. Individuals who cannot communicate in a language understandable by the research team. 4. Individuals with severe comorbidities that affect assessment or treatment (e.g., unable to safely complete assessments or treatments). 5. Individuals planning to undergo knee surgery during the study period.

Design outcomes

Primary

MeasureTime frameDescription
Fall Incident TrackingThree-month periodParticipants will be monitored for fall incidents over a three-month period, and the accuracy of the model predictions will be analyzed.

Secondary

MeasureTime frameDescription
POCUS AssessmentBaseline POCUS AssessmentPoint-of-care ultrasound is used to measure participants' muscle mass
Sarcopenia Risk Assessment Questionnaire (SARC-F)Baseline 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.
Bioelectrical Impedance Analysis (BIA) MeasurementBaseline BIA measurementConduct 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.
Knee extension strength testingBaseline knee extension strength testingAssesses 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.
Grip strength testingBaseline grip strengthMeasures 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.
30-Second Sit-to-Stand TestBaseline 30-Second Sit-to-Stand TestCounts 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.
Falls Efficacy Scale-International (FES-I)Baseline 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.
Body weight measurementBaseline body weight measurementMeasure the body weight of participants using a calibrated scale. Unit of Measure: Kilograms or pounds.
Height MeasurementBaseline height measurementRecord the participant's height using a stadiometer. Unit of Measure: Meters or centimeters.
Timed Up and Go (TUG) TestBaseline Timed Up and Go (TUG) TestEvaluates 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.

Countries

Taiwan

Contacts

Primary ContactChih-Chin Lai
b94408040@gmail.com886-988630906

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026