UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044191 |
|---|---|
| Receipt number | R000050461 |
| Scientific Title | Effect of garment forms on ease of wearing during dressing performance |
| Date of disclosure of the study information | 2021/05/25 |
| Last modified on | 2024/02/01 14:33:49 |
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Basic information
Public title
Effect of garment forms on ease of wearing during dressing performance
Acronym
The Influences of garment forms on dressing performance
Scientific Title
Effect of garment forms on ease of wearing during dressing performance
Scientific Title:Acronym
The Influences of garment forms on dressing performance
Region
| Japan |
Condition
Condition
Patients with physical disabilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we examine the comfort of wearing clothes with different shapes for dressing therapy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time required for dressing
FAD(Functional Dressing Assessment)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Raglan type(armhole)
Interventions/Control_2
Set-in type(armhole)
Interventions/Control_3
Sleeves of the same color
Interventions/Control_4
Left and right sleeves of different color
Interventions/Control_5
Clothes material(Cotton)
Interventions/Control_6
Clothes material(Nylon)
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>=20years
A patient who can understand the purpose of this study
Key exclusion criteria
Impairment consciousness patients
Can't hold a sitting position
Can't understand the instructions
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
School of Medicine
Zip code
514-1295
Address
424-1 Oodoricho, Tsu, Mie, Japan
TEL
059-252-1555
doctor.sonoda@nifty.ne.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Miyasaka |
Organization
Fujita Health University
Division name
Nanakuri Memorial Hospital
Zip code
514-1295
Address
424-1 Oodoricho, Tsu, Mie, Japan
TEL
059-252-1555
Homepage URL
hmiyasak@fujita-hu.ac.jp
Sponsor or person
Institute
Department of Rehabilitation Medicine II, School of Medicine, Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University Certified Clinical Research Review Board
Address
1-98, Dengakugakubo, Kutukakecho, Toyoake, Aichi
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2021 | Year | 05 | Month | 25 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 05 | Month | 25 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 02 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050461
