UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055428 |
|---|---|
| Receipt number | R000063332 |
| Scientific Title | Effect of different weight bearing on the stiffness of the deep hip joint tissues |
| Date of disclosure of the study information | 2024/09/06 |
| Last modified on | 2024/09/05 00:37:04 |
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Basic information
Public title
Effect of different loads on the stiffness of the deep hip joint tissues
Acronym
Different loads and stiffness of the deep hip joint tissues
Scientific Title
Effect of different weight bearing on the stiffness of the deep hip joint tissues
Scientific Title:Acronym
Weight bearing and stiffness of the deep hip joint tissues
Region
| Japan |
Condition
Condition
Hip osteoarthritis and healthy adults
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the tissue stiffness of the gluteus minimus and hip joint capsule in standing with different weight bearing in subjects with hip osteoarthritis and healthy subjects using ultrasound imaging and shear wave elastography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Shear modulus of the hip joint capsule, gluteus minimus, and gluteus medius
Key secondary outcomes
Hip pain, hip range of motion, hip abduction strength, hip special test, ADL score
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Weight bearing
Interventions/Control_2
Weight bearing
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hip osteoarthritis group: Patients aged 35 years or older with osteoarthritis of one hip joint (KL grade I-III)
Healty adults group: Healty adults aged 18 to 34
Key exclusion criteria
Hip osteoarthritis group: those who have difficulty with activities of daily living other than hip pain, those who have pain and neurological symptoms other than hip pain, those with a history of orthopedic surgery, those currently undergoing treatment or with a history of neuromuscular disease, cerebrovascular disease, or diabetes, those with cognitive impairment that makes it difficult to understand experiments, and those who have difficulty visiting the hospital alone.
Healty adults group: those who have had surgery for orthopedic disease, those currently undergoing treatment for orthopedic disease, those with a history of neuromuscular disease, cerebrovascular disease, or medical disease
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
350-0436
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
yokubo@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Okubo |
Organization
Saitama Medical University
Division name
Faculty of Health and Medical Care
Zip code
350-0436
Address
981, Kawakado, Moroyama-machi, Saitama
TEL
0492951001
Homepage URL
yokubo@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
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
Research Administration Center, Saitama Medical University
Address
981, Kawakado, Moroyama-machi, Saitama
Tel
0492762143
rinri@saitama-med.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
| 2024 | Year | 09 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 05 | Day |
Last modified on
| 2024 | Year | 09 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063332
