UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049351 |
|---|---|
| Receipt number | R000056201 |
| Scientific Title | Light Touch Effect in Standing up and Sitting down - Verification from smoothness of movement - |
| Date of disclosure of the study information | 2022/11/01 |
| Last modified on | 2023/04/29 21:39:31 |
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Basic information
Public title
Verification of Light Touch Effect in Standing up and Sitting down
Acronym
Verification of Light Touch Effect in Standing up and Sitting down
Scientific Title
Light Touch Effect in Standing up and Sitting down - Verification from smoothness of movement -
Scientific Title:Acronym
Verification of Light Touch Effect in Standing up and Sitting down
Region
| Japan |
Condition
Condition
Cases of impaired balance ability
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of light touch on the balance of standing up and sitting down from the aspect of smoothness. The hypothesis to be verified in this study is that when a healthy person stands up and sits down in an unstable environment, the smoothness of the movement can be improved by grasping the handrail and light touch. In addition, if the patient then stands up and sits down without supporting the upper limbs, the smoothness of the movement continues only after the light touch is performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
jerk cost index of Center of gravity
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Practice standing up and sitting down for 5 minutes while doing light touch
Interventions/Control_2
Practice standing up and sitting down for 5 minutes while supporting the handrail
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
healthy adult
Key exclusion criteria
(1)Subjects with orthopedic diseases in the trunk or lower extremities
(2)Subjects who have a history of orthopedic surgery
(3)Subjects who have experienced severe trauma in the past
(4)Subjects who have significant movement restrictions in the trunk,hip joints,knee joints,and ankle joints.
(5)Subjects whose dominant hand and hearing foot are opposite left and right (e.g. right-handed, left-handed)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Abe |
Organization
Saitama City Hospital
Division name
Department of Rehabilitation
Zip code
336-8522
Address
2460 Mimuro, Midori Ward, Saitama City, Saitama Prefecture
TEL
048-873-4111
yuki.abe0108@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Abe |
Organization
Saitama City Hospital
Division name
Department of Rehabilitation
Zip code
336-8522
Address
2460 Mimuro, Midori Ward, Saitama City, Saitama Prefecture
TEL
048-873-4111
Homepage URL
yuki.abe0108@gmail.com
Sponsor or person
Institute
Saitama City Hospital
Department of Rehabilitation
Institute
Department
Personal name
Funding Source
Organization
self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama City Hospital
Address
2460 Mimuro, Midori Ward, Saitama City, Saitama Prefecture
Tel
048-873-4111
yuki.abe0108@gmail.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
さいたま市立病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | 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
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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 27 | Day |
Last modified on
| 2023 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056201
