Tokyo, July 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062244) titled 'The Effects of Motor Unit Activity and Muscle Morphology of the Triceps Surae on Ankle Plantar Flexion Strength and Physical Function in Patients with Knee Osteoarthritis' on July 15.
Study Type:
Observational
Primary Sponsor:
Institute - Ibaraki Prefectural University of Health Sciences
Condition:
Condition - Knee Osteoarthritis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The purpose of this study is to quantify changes in the muscle morphology of the triceps surae in healthy individuals and patients with knee osteoarthritis according to disease severity, and to compare and examine the motor unit firing characteristics. Furthermore, the study aims to clarify the effects of triceps surae muscle morphology and motor unit firing characteristics on physical functions such as ankle plantar flexion strength and walking speed.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 50
years-old
=
Gender - Male and Female
Key inclusion criteria - Group of Patients with Knee OA:
(1) Individuals diagnosed with osteoarthritis of the knee by a physician
(2) Individuals aged 50 to 80
(3) Individuals who obtained approval from their attending physician
Healthy Control Group:
(1) Individuals currently receiving outpatient care at an orthopedic clinic (those with upper limb disorders [shoulder, elbow, or wrist disorders])
(2) Individuals aged 50 to 80
(3) Individuals for whom approval was obtained from their attending physician
Key exclusion criteria - Group of Patients with Knee OA
(1) Individuals with a history of lower limb or spinal surgery or a history of severe trauma
(2) Individuals with orthopedic conditions other than knee problems in the limb being measured
(3) Individuals with concomitant spinal disorders and neurological symptoms
(4) Individuals who are unable to live independently or walk without a walking aid
(5) Individuals with severe cognitive impairment who have difficulty understanding the test procedures or performing the tasks
(6) Individuals with skin disorders or significant edema at the measurement site
(7) Individuals with obesity (BMI over 30)
Healthy Control Group
(1) Individuals who meet exclusion criteria (1) through (7) for the osteoarthritis of the knee group
(2) Individuals who have been diagnosed with osteoarthritis of the knee in the past
(3) Individuals who experience knee pain during their daily activities
(4) Individuals with a history of knee trauma or surgery
Target Size - 45
Recruitment Status:
Recruitment status - Enrolling by invitation
Date of protocol fixation - 2026 Year 03 Month 25 Day
Date of IRB - 2026 Year 05 Month 28 Day
Anticipated trial start date - 2026 Year 07 Month 20 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071225
Disclaimer: Curated by HT Syndication.