UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045077 |
|---|---|
| Receipt number | R000050523 |
| Scientific Title | Development of measurement method for wheelchair seating and examination of the utility |
| Date of disclosure of the study information | 2021/08/20 |
| Last modified on | 2024/02/01 14:35:06 |
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Basic information
Public title
Development of measurement method for wheelchair seating and examination of the utility
Acronym
Development of measurement method for wheelchair seating and examination of the utility
Scientific Title
Development of measurement method for wheelchair seating and examination of the utility
Scientific Title:Acronym
Development of measurement method for wheelchair seating and examination of the utility
Region
| Japan |
Condition
Condition
Patients with physical disabilities
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of wheelchair seating.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Angle measurement using an accelerometer
Key secondary outcomes
Sitting pressure
Foot pressure
Wheelchair driving ability: driving time, number of driving, distance moved of the buttocks
Wheelchair driving posture evaluation
Stroke Impairment Assessment Set
Strength evaluation: Handheld dynamometer
Vital capacity
Functional Independence Measure(FIM)
Scale for Contraversive Pushing
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Behavior,custom |
Interventions/Control_1
Wheelchair with normal back support and seat cushion
Interventions/Control_2
Wheelchair with hard back support (J-system) and gel seat cushion
Interventions/Control_3
Wheelchair with normal back support and gel seat cushion
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with consent for this study
Key exclusion criteria
Patients with unstable general condition
Target sample size
60
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
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 Review Board
Address
1-98, Dengakugakubo, Kutukakecho, Toyoake, Aichi
Tel
0562-93-2865
crb-f@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 | 08 | 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
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 | 08 | Month | 06 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 20 | 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 | 08 | Month | 06 | 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=R000050523
