UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053639 |
|---|---|
| Receipt number | R000061222 |
| Scientific Title | Effects of a newly developed standing assist device on activities of daily living for the people certified for long-term care/support need: a feasibility study |
| Date of disclosure of the study information | 2024/02/20 |
| Last modified on | 2024/02/18 14:48:57 |
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Basic information
Public title
Effects of a newly developed standing assist device on activities of daily living for the people certified for long-term care/support need: a feasibility study
Acronym
Effects of a newly developed standing assist device on activities of daily living
Scientific Title
Effects of a newly developed standing assist device on activities of daily living for the people certified for long-term care/support need: a feasibility study
Scientific Title:Acronym
Effects of a newly developed standing assist device on activities of daily living : a feasibility study
Region
| Japan |
Condition
Condition
Older people in need of care who live in a facility or use day care services
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This feasibility study will examine the effect of lower limb strength training using a squat device with handrails on the level of independence in daily living for persons requiring nursing care or support.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary outcome: Barthel Index, lower limb strength
Key secondary outcomes
Secondary outcome: Timed Up & Go Test, Mini-cog, LSI-Z, WHOQOL-OLD, Questionnaires during and after intervention, adherence, dropout rates
Base
Study type
Interventional
Study design
Basic design
Parallel
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
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
In addition to the regular rehabilitation program, the participants will stand up using a squatting device with handrails for 12 weeks. The device was set up in a rehabilitation room or on the floor of the facility, and under the supervision of a physical therapist or occupational therapist, the participants stood up three times a week, 40 times in 10 minutes, holding the handrail in front of them so that their trunk was tilted forward while in the sitting position. The date and number of times performed were recorded. The standing up was basically performed with a video image displayed in front of the device, with 5 seconds of standing up, 5 seconds of sitting down, and 5 seconds of rest.
Interventions/Control_2
Regular rehabilitation program
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
Those who need assistance in standing up, those who have not been diagnosed with dementia, and those who are able to communicate.
Key exclusion criteria
Those who are prohibited from standing up or exercising by their attending physician.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
TEL
072-950-2111
yokoikat@omu.ac.jp
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Yokoi |
Organization
Osaka Metropolitan University
Division name
Graduate School of Rehabilitation Science
Zip code
583-8555
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
TEL
072-950-2111
Homepage URL
yokoikat@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
Osaka Metropolitan University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
a.l. corporation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University, Committee on Research Ethics
Address
3-7-30 Habikino, Habikino-City,Osaka 583-8555, JAPAN
Tel
072-950-2111
yokoikat@omu.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
| 2024 | Year | 02 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | 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
| 2024 | Year | 02 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061222
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
