UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057343 |
|---|---|
| Receipt number | R000065541 |
| Scientific Title | Consideration of toilet bowl and seat conditions that facilitate standing in elderly people with kyphosis 2 |
| Date of disclosure of the study information | 2025/03/20 |
| Last modified on | 2025/03/19 16:29:36 |
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Basic information
Public title
Consideration of toilet bowl and seat conditions that facilitate standing in elderly people with kyphosis 2
Acronym
Consideration of toilet bowl and seat conditions that facilitate standing in elderly people with kyphosis 2
Scientific Title
Consideration of toilet bowl and seat conditions that facilitate standing in elderly people with kyphosis 2
Scientific Title:Acronym
Consideration of toilet bowl and seat conditions that facilitate standing in elderly people with kyphosis 2
Region
| Japan |
Condition
Condition
Kyphosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A growing elderly population necessitates increased long-term care. Prior studies underscore toileting as a critical challenge in both home care and post-hospitalization rehabilitation, highlighting the urgent need to enhance toileting independence.
The ability to rise from a seated position is fundamental to independent toileting. The design of toilet seats significantly influences this movement. Healthy individuals intuitively adjust trunk flexion and extension to minimize strain on the lower limbs. However, conditions such as kyphosis, which are prevalent among the elderly, impose limitations on trunk mobility, thereby potentially impeding the ability to stand from a toilet seat.
This study aims to investigate the characteristics of toilet and seat configurations, referred to as "modified settings," that facilitate standing for individuals with kyphosis, in comparison to standard settings. The initial phase of this research focuses on detailed motion and electromyographic analyses conducted on young, healthy adults simulating kyphosis through the use of trunk orthoses. Specifically, five distinct modified seat designs are evaluated in this phase, with the aim of selecting the two most effective designs for further testing. In this study, these two selected designs will be further evaluated through motion and electromyographic analyses, as well as sensory evaluations, involving elderly individuals with diagnosed kyphosis. The ultimate objective of this study is to elucidate the essential features of a toilet seat that effectively supports and enhances standing ability for individuals with kyphosis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensory evaluation (five-level evaluation of seated posture comfort and sit-to-stand performance)
Evaluation Period: During Task Performance Measurement
Key secondary outcomes
Sit-to-stand time
Percent Average Rectified Value normalized to Maximum Voluntary Contraction of the erector spinae, rectus femoris, biceps femoris, and tibialis anterior muscles during the phases of standing initiation to lift-off and lift-off to standing completion.
Sagittal plane angles of the pelvis, thorax, and pelvis-thorax relative angles during sitting.
Maximum values of pelvic and thoracic anterior tilt, and pelvis-thorax relative flexion angles during standing up motion.
Evaluation Period: During Task Performance Measurement
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
"normal setting": A combination of an unmodified TOTO CS497BD floor-mounted floor-drain toilet (hereinafter, toilet bowl) and a TOTO TC291Y large-sized standard toilet seat (hereinafter, toilet seat).
Interventions/Control_2
"3 cm higher": The toilet seat raised 3 cm above the toilet bowl.
Interventions/Control_3
"5 degree tilt": The toilet seat tilted forward by 5 degree on the toilet bowl.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Individuals who met all of the following criteria were selected:
Able to provide written informed consent for research participation based on their own free will.
Aged 65 years or older (set as the elderly period).
Exhibiting kyphosis (defined as having a kyphosis index of mild or greater).
Able to perform a standing up motion without using upper limbs.
Key exclusion criteria
Presence of central nervous system disease.
Target sample size
29
Research contact person
Name of lead principal investigator
| 1st name | Munehito |
| Middle name | |
| Last name | Kamakura |
Organization
Nakaizu Rehabilitation Center
Division name
Department of Physical Therapy, Rehabilitation Division
Zip code
410-2507
Address
1523-108 Hiekawa, Izu-shi, Shizuoka-ken, Japan
TEL
0558-83-2111
mu-kamakura@janrc.or.jp
Public contact
Name of contact person
| 1st name | Munehito |
| Middle name | |
| Last name | Kamakura |
Organization
International University of Health & Welfare Graduate School
Division name
Department of Assistive Technological Science
Zip code
107-8402
Address
4-1-26,Akasaka,Minato-ku,Tokyo,Japan
TEL
03-5574-3900
Homepage URL
mu-kamakura@janrc.or.jp
Sponsor or person
Institute
International University of Health & Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health & Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health & Welfare Graduate School
Address
4-1-26,Akasaka,Minato-ku,Tokyo,Japan
Tel
03-5574-3900
otoiawase@iuhw.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
| 2025 | Year | 03 | Month | 20 | 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
16
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Results will be published after journal submission.
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2023 | 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 | 03 | Month | 19 | Day |
Last modified on
| 2025 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065541
