Clinical trial NCT06882928: Applications of Ultrasound and Physical Parameters in Assessing Fall Risk in Patients With Knee Osteoarthritis
Official title: Applications of Ultrasound and Physical Parameters in Assessing Fall Risk Among Patients With Knee Osteoarthritis: A Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Knee Osteoarthritis
Ultrasound Exams
Fall Risk
Sarcopenia in Elderly
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 250
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Fall Incident Tracking
timeFrame: Three-month period
Secondary outcomes:
measure: Grip strength testing
timeFrame: Baseline grip strength
measure: POCUS Assessment
timeFrame: Baseline POCUS Assessment
measure: Sarcopenia Risk Assessment Questionnaire (SARC-F)
timeFrame: Baseline Sarcopenia Risk Assessment Questionnaire (SARC-F)
measure: Bioelectrical Impedance Analysis (BIA) Measurement
timeFrame: Baseline BIA measurement
measure: Knee extension strength testing
timeFrame: Baseline knee extension strength testing
measure: Timed Up and Go (TUG) Test
timeFrame: Baseline Timed Up and Go (TUG) Test
measure: 30-Second Sit-to-Stand Test
timeFrame: Baseline 30-Second Sit-to-Stand Test
measure: Falls Efficacy Scale-International (FES-I)
timeFrame: Baseline Falls Efficacy Scale-International (FES-I)
measure: Body weight measurement
timeFrame: Baseline body weight measurement
measure: Height Measurement
timeFrame: Baseline height measurement
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTUH
Study officials:
References: