UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057992 |
|---|---|
| Receipt number | R000066272 |
| Scientific Title | A Prospective Observational Study Investigating the Effects of Foot Alignment Variations on Trunk Muscle Thickness and Motor Function in Activities of Daily Living |
| Date of disclosure of the study information | 2025/06/01 |
| Last modified on | 2025/05/28 08:25:10 |
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Basic information
Public title
A Prospective Observational Study Investigating the Effects of Foot Alignment Variations on Trunk Muscle Thickness and Motor Function in Activities of Daily Living
Acronym
A Prospective Observational Study Investigating the Effects of Foot Alignment Variations on Trunk Muscle Thickness and Motor Function in Activities of Daily Living
Scientific Title
A Prospective Observational Study Investigating the Effects of Foot Alignment Variations on Trunk Muscle Thickness and Motor Function in Activities of Daily Living
Scientific Title:Acronym
A Prospective Observational Study Investigating the Effects of Foot Alignment Variations on Trunk Muscle Thickness and Motor Function in Activities of Daily Living
Region
| Japan |
Condition
Condition
Elderly individuals aged 65 and over
Classification by specialty
| Urology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of differences in foot alignment (pronated, neutral, and supinated feet) on trunk muscle activity and motor ADL in the elderly, and to explore methods that support their return to home.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Foot Alignment
* FPI-6 (Foot Posture Index)
* Visual inspection of knee joint alignment
2. Trunk Muscle Thickness (measured by ultrasound)
* External oblique muscle
* Internal oblique muscle
* Transversus abdominis muscle
* Multifidus muscle at L2 and L5
* Erector spinae muscle at L3
3. Urinary Function
* Presence or absence of urethral catheterization
* Presence or absence of intermittent catheterization at least once a week
* Type of underwear (diaper, disposable pull-up pants, or cloth underwear)
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals who have provided written informed consent to participate in the study
Men and women aged 65 years or older at the time of consent
Individuals newly admitted to the convalescent rehabilitation ward of our hospital
Key exclusion criteria
Individuals who were transferred to another ward or hospital due to comorbidities during hospitalization
Individuals who died due to comorbidities during hospitalization
Individuals who did not provide consent to participate in the study
Individuals deemed unsuitable for inclusion in the study by the principal investigator
Individuals readmitted to the convalescent rehabilitation ward of our hospital
Individuals with a FIM toilet transfer score of 3 or lower
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | nishimura |
Organization
Medical Corporation Kohninkai Akashi Ninju Hospital
Division name
Division of rehabilitation
Zip code
674-0074
Address
1871-3 Shimizu, Uozumi-cho, Akashi City, Hyogo Prefecture, Japan
TEL
078-942-1921
reha@kojinkai.hyogo.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | nishimura |
Organization
Medical Corporation Kohninkai Akashi Ninju Hospital
Division name
Division of rehabilitation
Zip code
674-0074
Address
1871-3 Shimizu, Uozumi-cho, Akashi City, Hyogo Prefecture, Japan
TEL
078-942-1921
Homepage URL
reha@kojinkai.hyogo.jp
Sponsor or person
Institute
Medical Corporation Kohninkai Akashi Ninju Hospital
Institute
Department
Personal name
Funding Source
Organization
Medical Corporation Kohninkai Akashi Ninju Hospital
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Kohninkai Akashi Ninju Hospital
Address
1871-3 Shimizu, Uozumi-cho, Akashi City, Hyogo Prefecture, Japan
Tel
078-942-1921
reha@kojinkai.hyogo.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
| 2025 | Year | 06 | Month | 01 | 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
| 2025 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate the effects of differences in foot alignment on trunk muscle activity in older adults, as well as the relationship between foot alignment, motor activities of daily living (ADL), and urinary function.
Management information
Registered date
| 2025 | Year | 05 | Month | 28 | Day |
Last modified on
| 2025 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066272
