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

NCT06882928 | Not Yet Recruiting

• 1 other identifier: 202501047RINA
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Three-month period

Secondary Outcomes (10)

• Grip strength testing

  Baseline grip strength

• POCUS Assessment

  Baseline POCUS Assessment

• Sarcopenia Risk Assessment Questionnaire (SARC-F)

  Baseline Sarcopenia Risk Assessment Questionnaire (SARC-F)

• Bioelectrical Impedance Analysis (BIA) Measurement

  Baseline BIA measurement

• Knee extension strength testing

  Baseline knee extension strength testing

Study Arms (1)

knee osteoarthritis

Males and females aged 60 and above must have a clinically confirmed diagnosis of knee osteoarthritis.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Clinical Trial Center: lead

Study Sites (1)

NTUH

Taipei, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Chih-Chin Lai

CONTACT

886-988630906; b94408040@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 19, 2025
• Study Start: March 24, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)