UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050621 |
|---|---|
| Receipt number | R000057662 |
| Scientific Title | Pilot study for a randomized controlled trial on the actual condition of walking and improvement through instruction |
| Date of disclosure of the study information | 2023/03/18 |
| Last modified on | 2023/09/15 11:15:57 |
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Basic information
Public title
Pilot study for a randomized controlled trial on the actual condition of walking and improvement through instruction
Acronym
Pilot study of actual conditions of walking and improvement through instruction
Scientific Title
Pilot study for a randomized controlled trial on the actual condition of walking and improvement through instruction
Scientific Title:Acronym
Pilot study of actual conditions of walking and improvement through instruction
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a pilot study to examine the feasibility and validity of effectiveness determinations for a randomized controlled trial to test the effectiveness of walking instruction provided in pharmacies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall score of average acceleration with safety walk navigation system
Key secondary outcomes
Posture when standing and walking
Average acceleration and score of up/down, left/right front by safety walk navigation system
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
walking instruction
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Students currently enrolled at Showa Pharmaceutical University who meet all of the following criteria:
Age between 18 and 40 years old on the date consent is obtained.
Persons who have obtained the subject's written consent to participate in this study.
Key exclusion criteria
People with hypersensitivity to the materials in the Walking Impact Analysis System (Safety Walk Navi) and the rise test box.
People with pain, swelling, inflammation, injury, or paralysis of the lower limbs and with limited ambulation.
People who cannot be fitted with the Safety Walk Navi device.
Persons who are otherwise deemed unsuitable as subjects by the principal investigator.(Keep a record of the reasons for exclusion.)
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Chigusa |
| Middle name | |
| Last name | Kikuchi |
Organization
Showa Pharmaceutical University
Division name
Department of Community Medicine, Center for Clinical Pharmacy Education and Research
Zip code
194-8543
Address
3-3165 Higashi-Tamagawa Gakuen, Machida, Tokyo
TEL
+81-42-721-1535
c-kikuchi@ac.shoyaku.ac.jp
Public contact
Name of contact person
| 1st name | Chigusa |
| Middle name | |
| Last name | Kikuchi |
Organization
Showa Pharmaceutical University
Division name
Department of Community Medicine, Center for Clinical Pharmacy Education and Research
Zip code
194-8543
Address
3-3165 Higashi-Tamagawa Gakuen, Machida, Tokyo
TEL
+81-42-721-1535
Homepage URL
c-kikuchi@ac.shoyaku.ac.jp
Sponsor or person
Institute
Showa Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Showa Pharmaceutical University
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
Showa Pharmaceutical University Ethics Review Committee
Address
Postal Code 194-8543 3-3165 Higashi-Tamagawa Gakuen, Machida, Tokyo
Tel
+81-42-721-1511
shomu@ad.shoyaku.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
| 2023 | Year | 03 | Month | 18 | 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
Completed
Date of protocol fixation
| 2023 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 03 | Month | 17 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057662
