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NCT Number: NCT06882928

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

NTUH

Taipei, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Grip strength testing

    Time frame: Baseline grip strength

    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.

  2. POCUS Assessment

    Time frame: Baseline POCUS Assessment

    Point-of-care ultrasound is used to measure participants' muscle mass

  3. Sarcopenia Risk Assessment Questionnaire (SARC-F)

    Time frame: 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.

  4. Bioelectrical Impedance Analysis (BIA) Measurement

    Time frame: Baseline 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.

  5. Knee extension strength testing

    Time frame: Baseline 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.

  6. Timed Up and Go (TUG) Test

    Time frame: Baseline 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.

  7. 30-Second Sit-to-Stand Test

    Time frame: Baseline 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.

  8. Falls Efficacy Scale-International (FES-I)

    Time frame: 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.

  9. Body weight measurement

    Time frame: Baseline body weight measurement

    Measure the body weight of participants using a calibrated scale. Unit of Measure: Kilograms or pounds.

  10. Height Measurement

    Time frame: Baseline height measurement

    Record the participant's height using a stadiometer. Unit of Measure: Meters or centimeters.

Study contacts

Contact information is provided by the study sponsor or research team.

Chih-Chin Lai

CONTACT

[email protected]

886-988630906

Sponsors and collaborators

Lead sponsor

National Taiwan University Clinical Trial Center

Other

Registry information

Official study title

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

Acronym: UPPFR-KneeOA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 19, 2025
Registry last updated
Mar 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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