UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062960 |
|---|---|
| Receipt number | R000072090 |
| Scientific Title | Effects of Different Wheelchair Seat Surfaces on Interface Pressure Distribution and Perceived Comfort: An Exploratory Randomized Crossover Trial |
| Date of disclosure of the study information | 2026/09/17 |
| Last modified on | 2026/09/17 14:50:26 |
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Basic information
Public title
Effects of Different Wheelchair Seat Surfaces on Interface Pressure Distribution and Perceived Comfort
Acronym
Effects of Different Wheelchair Seat Surfaces
Scientific Title
Effects of Different Wheelchair Seat Surfaces on Interface Pressure Distribution and Perceived Comfort: An Exploratory Randomized Crossover Trial
Scientific Title:Acronym
Effects of Different Wheelchair Seat Surfaces
Region
| Japan |
Condition
Condition
Wheelchair users and healthy individuals
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of different wheelchair seat surfaces.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peak interface pressure
Key secondary outcomes
Contact area
asymmetry
High-pressure area
Seating comfort
Perceived stability
Discomfort
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wheelchair seat made of elastic woven fabric
Interventions/Control_2
Conventional wheelchair seat made of nylon fabric
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria for the Wheelchair User Group
Individuals who use a wheelchair on a daily basis.
Individuals classified as Level1 on the Hoffer Sitting Ability Classification.
Individuals who understand the study information and can provide informed consent.
Individuals who can understand the assessor's instructions and complete self-reported assessments.
Individuals considered able to undergo the measurements safely at an adult day-care facility or similar setting.
Inclusion Criteria for the Healthy Adult Group
Healthy adults who understand the study information and can provide informed consent.
Key exclusion criteria
Exclusion Criteria for the Wheelchair User Group
Individuals who have difficulty understanding the study information or measurement instructions because of severe cognitive impairment, aphasia, higher cortical dysfunction, or a similar condition.
Individuals who are unable to maintain a quiet seated position during measurements or who have marked involuntary movements.
Individuals with active pressure injuries, wounds, or severe skin lesions on the buttocks or posterior thighs.
Individuals who are unable to continue the measurements because of severe pain or distress.
Individuals who are unable to maintain the standardized sitting posture because of severe spinal deformity, pelvic deformity, joint contracture, or a similar condition.
Individuals whose body weight exceeds the safe operating limit of the measurement equipment or study wheelchair.
Individuals considered unsuitable for participation by the principal investigator or the therapist responsible for the assessment.
Exclusion Criteria for the Healthy Adult Group
Individuals with a medical history or condition that makes it difficult to maintain a seated position, those with pain or skin lesions on the buttocks or thighs, or those considered unable to undergo the measurements safely.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ryu |
| Middle name | |
| Last name | Kokuwa |
Organization
Syupoon Inc.
Division name
Department of Paracane and Lococane
Zip code
4980026
Address
43, Nishimaeshinden, Uguiura, Yatomi, Aichi, 498-0026, JAPAN
TEL
0567558253
kokuwa@welloop.co.jp
Public contact
Name of contact person
| 1st name | Ryu |
| Middle name | |
| Last name | Kokuwa |
Organization
Syupoon Inc.
Division name
Department of Paracane and Lococane
Zip code
4980026
Address
43, Nishimaeshinden, Uguiura, Yatomi, Aichi, 498-0026, JAPAN
TEL
0567558253
Homepage URL
kokuwa@welloop.co.jp
Sponsor or person
Institute
Welloop Inc.
Institute
Department
Personal name
Ryu Kokuwa
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Toray Industries, Inc.
IRB Contact (For public release)
Organization
Welloop Inc. Research Ethics Review Committee
Address
43, Nishimaeshinden, Uguiura, Yatomi, Aichi, 498-0026, JAPAN
Tel
0567558253
tomoko@welloop.co.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 | 09 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 07 | 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
Management information
Registered date
| 2026 | Year | 09 | Month | 17 | Day |
Last modified on
| 2026 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072090
