UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047138 |
|---|---|
| Receipt number | R000053770 |
| Scientific Title | Effectiveness testing of a physical intervention (escort method) in a comprehensive violence prevention programme: a crossover controlled trial. |
| Date of disclosure of the study information | 2022/03/13 |
| Last modified on | 2024/09/09 14:18:38 |
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Basic information
Public title
Effectiveness testing of a physical intervention (escort method) in a comprehensive violence prevention programme: a crossover controlled trial.
Acronym
Effectiveness testing on the CVPPP escort method
Scientific Title
Effectiveness testing of a physical intervention (escort method) in a comprehensive violence prevention programme: a crossover controlled trial.
Scientific Title:Acronym
Effectiveness testing on the CVPPP escort method
Region
| Japan |
Condition
Condition
Healthy persons
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effectiveness of the escort method used in psychiatry. Showing that the escort method in the correct way is less psychologically demanding on the patient and more stable.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjectivity (mood and image) of the subject being escorted
Key secondary outcomes
Changes in maximal muscle strength by electromyography, changes in RR intervals, changes in arm movement by accelerometry.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Intervention 1 (regular method) 30 s. Intervention 2 (non-regular method) 30 s for a total of 60 s. For both interventions 1 and 2, 3 sets of shoulder exercises at maximal muscle strength for 5 s, rest for 5 s.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) health persons aged 20 years and over in 2021, and healthy persons aged 18 years and over from 2022 *in line with the change in the age of majority.
(ii) Those with no physical disability to perform the escort method.
(iii) Able to stand for three minutes.
(iv) Subjects who, after receiving a full explanation of their participation in the study, have given their written consent based on their own free will.
(v) Those with no metal allergies.
Key exclusion criteria
(i) Persons with physical ailments that interfere with even light exercise, or who have a complaint against them.
(ii) Those who are allergic to metal electrodes in EMG.
(iii) Persons for whom consent by a surrogate is required.
(iv) Any other person deemed unsuitable as a subject by the principal investigator.
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Shimosato |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
3908621
Address
3-1-1Asahi Matsumoto , Ngano
TEL
0263372382
sshimos@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiji |
| Middle name | |
| Last name | Shimosato |
Organization
Shinshu University
Division name
School of Health Sciences
Zip code
390
Address
3-1-1Asahi Matsumoto Nagano
TEL
0263372382
Homepage URL
sshimos@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Shinshu University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Committee of Shinshu University School of Medicine
Address
3-1-1Asahi Matsumoto
Tel
0263-37-2572
mdrinri@shinshu-u.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
| 2022 | Year | 03 | Month | 13 | 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
| 2022 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 10 | Day |
Last modified on
| 2024 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053770
| Research Plan | |
|---|---|
| Registered date | File name |
| 2024/08/15 | 20220702シモサト介入研究プロトコール雛形_第７版(210819)_20220126.pdf |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2024/08/15 | 最終データ登録仕様書.pdf |
| Research case data | |
|---|---|
| Registered date | File name |
| 2024/08/15 | 最終結果エスコート_40 UTF8 2.csv |
Single case data URL
Value
https://center6.umin.ac.jp/ice/53770
