UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027369 |
|---|---|
| Receipt number | R000031364 |
| Scientific Title | Intervention study to test the effect that cha nged the silver car to rollator about elderly people with frailty |
| Date of disclosure of the study information | 2017/07/01 |
| Last modified on | 2022/05/23 15:46:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Intervention study to test the effect that cha
nged the silver car to rollator about elderly
people with frailty
Acronym
Intervention study of the walking aid
Scientific Title
Intervention study to test the effect that cha
nged the silver car to rollator about elderly
people with frailty
Scientific Title:Acronym
Intervention study of the walking aid
Region
| Japan |
Condition
Condition
The person who uses a daycare among elderly people who require long-term care
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In before and after that changed the silver car to rollator, we compare the walking amount
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking amount
Key secondary outcomes
Frenchay Activities Index
Fall Efficacy Scale
Evaluation of Satisfacion with assistive Technology 2.0
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Intervention group
1.We have you use a silver car using routinely for one week
2.We change a silver car using routinely to walking frames with wheels and have you use it for three weeks
3.We have you use a silver car using routinely for one week
Interventions/Control_2
Non-intervention group
We have you use a silver car using routinely for five weeks
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.The person who uses silver car routinely
2.Person without suspicion of dementia
3.The person who is available for verbal communication
Key exclusion criteria
The person who does not agree to an
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Kitajima |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of medical Science
Zip code
814-0001
Address
3-6-40,Momochihama,sawaraku,Fukuoka
TEL
092-832-1200
kitajima@takagigakuen.ac.jp
Public contact
Name of contact person
| 1st name | Eiji |
| Middle name | |
| Last name | Kitajima |
Organization
Fukuoka International University of Health and Welfare
Division name
Faculty of medical Science
Zip code
814-0001
Address
3-6-40,Momochihama,sawaraku,Fukuoka
TEL
092-832-1200
Homepage URL
kitajima@takagigakuen.ac.jp
Sponsor or person
Institute
Fukuoka International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Japan Sience and Technology Agency
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
Fukuoka International University of Health and Welfare
Address
3-6-40,Momochihama,sawaraku,Fukuoka
Tel
092-832-1200
kitajima@takagigakuen.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
| 2017 | Year | 07 | 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
| Delay expected |
Results Delay Reason
Due to the effects of the new coronavirus infection (COVID19), research participation by facility users has been delayed.
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
| 2017 | Year | 04 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For infection prophylaxis of the coronavirus, the comings and goings to a cooperation institution are limited.Therefore the investigation that we planned was delayed and extended an investigation period.
Management information
Registered date
| 2017 | Year | 05 | Month | 17 | Day |
Last modified on
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031364
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
