UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058715 |
|---|---|
| Receipt number | R000067114 |
| Scientific Title | A Pilot Intervention Study Using Markerless Motion Capture to Evaluate the Effects of Posture Walking on Gait Biomechanics and Pain in Women with Pelvic Girdle Pain |
| Date of disclosure of the study information | 2025/08/06 |
| Last modified on | 2025/08/06 17:19:21 |
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Basic information
Public title
Effect of Posture Walking Intervention on Gait Biomechanics in Women with Pelvic Girdle Pain
Acronym
Effect of Posture Walking Intervention on Gait Biomechanics in Women with Pelvic Girdle Pain
Scientific Title
A Pilot Intervention Study Using Markerless Motion Capture to Evaluate the Effects of Posture Walking on Gait Biomechanics and Pain in Women with Pelvic Girdle Pain
Scientific Title:Acronym
Posture Walking and Gait in Women with Pelvic Girdle Pain
Region
| Japan |
Condition
Condition
Back pain/Pelvic girdle pain
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The first objective of this study is to evaluate and compare gait biomechanics between women with pelvic girdle pain (PGP) and healthy controls using markerless motion capture, in order to identify characteristic gait patterns associated with PGP.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Change rate in the Oswestry Disability Index (ODI) score before and after the posture walking intervention.
Key secondary outcomes
Changes in subjective well-being
Changes in fear-avoidance beliefs score
Changes in gait biomechanics measured by markerless motion capture, including:
Peak hip flexion moment
Total hip joint work and contribution ratio
Pelvic tilt angle
Aesthetic score (ordinal variable)
Step interval
Stride width
Center of mass width during walking
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Maneuver |
Interventions/Control_1
Name: Posture Walking Training
Target group: Women aged 18 to under 60 years with pelvic girdle pain (PGP)
Description: A total of three posture walking sessions over two months
Session 1: In-person (45 minutes at the measurement site)
Sessions 2 and 3: Online via Zoom (45 minutes each)
Interventions/Control_2
control
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
| 59 | years-old | >= |
Gender
Female
Key inclusion criteria
Participants must meet all of the following criteria:
Able to visit the measurement site at Okayama University Hospital by September 30, 2026
Able to provide written informed consent voluntarily
Female, aged 18 years or older and under 60 years at the time of consent
Body weight less than 100 kg
Able to walk independently without assistive devices such as canes or walkers
Capable of communicating in Japanese
Key exclusion criteria
Participants who meet any of the following criteria will be excluded
History of knee or hip surgery within the past 3 months
Diagnosed with neuromuscular disorders such as Parkinsons disease or multiple sclerosis
Currently pregnant
History of pelvic, vertebral, or femoral fracture within the past 6 months
Has physical pain requiring medical treatment
History of myocardial infarction within the past 2 years
Has moderate to severe heart disease, including aortic stenosis, acute pericarditis, aortic aneurysm, symptomatic angina, symptomatic valvular disease, untreated arrhythmias, or intermittent claudication
Has uncontrolled atrial fibrillation
History of stroke(cerebral infarction) within the past 2 years
Respiratory dysfunction, including, Use of home oxygen therapy, Being treated for airway-obstructing conditions (e.g., thyroid tumor, metastatic tumor)
Severe renal dysfunction (e.g., currently on dialysis)
Resting systolic blood pressure >200 mmHg or diastolic blood pressure >100 mmHg
Judged by the investigator to be inappropriate for study participation (e.g., insufficient understanding of the study, objection to study procedures, etc.)
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Jota |
| Middle name | |
| Last name | Maki |
Organization
Okayama university
Division name
Medical Development Field, Center for Innovative Clinical Medicine
Zip code
70008558
Address
2-5-1, Shikata, Okayama
TEL
0862357320
tomohiro.mitoma@gmail.com
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Mitoma |
Organization
Okayama university
Division name
Medical Development Field, Center for Innovative Clinical Medicine
Zip code
7008558
Address
2-5-1, Shikata, Okayama
TEL
0862237151
Homepage URL
tomohiro.mitoma@gmail.com
Sponsor or person
Institute
Okayama university
Institute
Department
Personal name
Funding Source
Organization
Okayama university
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
Okayama University Clinical Research Review Board for Medical Departments
Address
2-5-1, Shikata-chou, Kita-ku
Tel
0862237151
mae6605@adm.okayama-u.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
岡山県
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2025 | 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
| 2025 | Year | 08 | Month | 06 | Day |
Last modified on
| 2025 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067114
