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Not yet recruiting NCT06882928

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

Observational Knee Osteoarthritis Ultrasound Exams Fall Risk Sarcopenia in Elderly

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Knee Osteoarthritis, Ultrasound Exams, Fall Risk, Sarcopenia in Elderly. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Fall Incident Tracking [Time frame: Three-month period]
Secondary outcome measures (10)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • NTUH — Taipei

Identifiers

NCT: NCT06882928 · 202501047RINA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗