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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000033882 |
Receipt No. | R000038646 |
Scientific Title | A study about the improvement in effect of movement by walking assist instruments (part 2) |
Date of disclosure of the study information | 2018/09/05 |
Last modified on | 2020/02/26 |
Basic information | ||
Public title | A study about the improvement in effect of movement by walking assist instruments (part 2) | |
Acronym | A study about the improvement in effect of movement by walking assist instruments (part 2) | |
Scientific Title | A study about the improvement in effect of movement by walking assist instruments (part 2) | |
Scientific Title:Acronym | A study about the improvement in effect of movement by walking assist instruments (part 2) | |
Region |
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Condition | |||
Condition | Pre-Frailty | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | To consider the effect on gait by using walking assist instruments |
Basic objectives2 | Others |
Basic objectives -Others | To compare the effect on gait by the presence or absence of walking assist instruments. |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Evaluation of the interventional of walking assist instruments about physical activity, gait function, body composition, cognitive function. |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Educational,Counseling,Training | |
Type of intervention |
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Interventions/Control_1 | Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six weeks. -> Wash out for two weeks. -> Walking for 10 minutes for six weeks. | |
Interventions/Control_2 | Walking for 10 minutes for six weeks. -> Wash out for two weeks. -> Participation in the walking lesson by using walking assist instruments once a week and walking using them for 10 minutes for six 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Subjects applied for one or two of the flail evaluation standards (all five questions) created by the National Center for Geriatrics and Gerontology. | |||
Key exclusion criteria | -Subjects with difficult for walking.
-Subjects deemed inappropriate to participate in this study by the principle investigator. |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Kao Corporation | ||||||
Division name | R&D -Development Research- Personal Health Care Research | ||||||
Zip code | 131-8501 | ||||||
Address | 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN | ||||||
TEL | +81-3-5630-7486 | ||||||
sudo.motoki@kao.com |
Public contact | |||||||
Name of contact person |
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Organization | Kao Corporation | ||||||
Division name | R&D -Development Research- Personal Health Care Research | ||||||
Zip code | 131-8501 | ||||||
Address | 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN | ||||||
TEL | +81-3-5630-7486 | ||||||
Homepage URL | |||||||
ueda.tomoya@kao.com |
Sponsor | |
Institute | Kao Corporation |
Institute | |
Department |
Funding Source | |
Organization | Kao Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Human Research Ethics Committee, Kao COrporation |
Address | 2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN |
Tel | +81-3-5630-9220 |
uesaka.toshio@kao.com |
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 | まちの健康研究所「あ・し・た」(千葉県) |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | 30 |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038646 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |