UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062244 |
|---|---|
| Receipt number | R000071225 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/07/15 |
| Last modified on | 2026/07/15 09:46:22 |
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Basic information
Public title
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
Acronym
Investigation of the Functional Role of the Triceps Surae in Patients with Knee Osteoarthritis
Scientific Title
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
Scientific Title:Acronym
Investigation of the Functional Role of the Triceps Surae in Patients with Knee Osteoarthritis
Region
| Japan |
Condition
Condition
Knee Osteoarthritis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Muscle activity of the gastrocnemius and soleus muscles, ultrasound images, 5-meter walking speed, Timed Up & Go test, 10-repeat sit-to-stand test
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 80 | 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 sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Aoyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Physical Therapy
Zip code
300.0394
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
TEL
029-888-4000
aoyamato@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Aoyama |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Physical Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
TEL
029-888-4000
Homepage URL
aoyamato@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of the Ibaraki Prefectural University of Health Sciences
Address
4669-2 Ami, Ami Town, Inashiki District, Ibaraki Prefecture
Tel
029-888-4000
aoyamato@ipu.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No special notes
Management information
Registered date
| 2026 | Year | 07 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071225
