UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047654 |
|---|---|
| Receipt number | R000054340 |
| Scientific Title | Investigation of trunk muscle activity during lifting expected and unexpected weight |
| Date of disclosure of the study information | 2022/05/05 |
| Last modified on | 2022/05/06 15:00:35 |
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Basic information
Public title
Investigation of trunk muscle activity during lifting expected and unexpected weight
Acronym
Investigation of trunk muscle activity during lifting expected and unexpected weight
Scientific Title
Investigation of trunk muscle activity during lifting expected and unexpected weight
Scientific Title:Acronym
Investigation of trunk muscle activity during lifting expected and unexpected weight
Region
| Japan |
Condition
Condition
Healthy persons
Chronic low back pain
Classification by specialty
| Orthopedics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of the expectation of an object's weight on trunk muscle activity using surface electrodes.
To identify trunk muscle activity in people with chronic low back pain.
Basic objectives2
Others
Basic objectives -Others
Differences in trunk muscle activity with and without prediction of object weight
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in trunk muscle activity with and without weight prediction
Key secondary outcomes
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Lifting object
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
| 22 | years-old | >= |
Gender
Male
Key inclusion criteria
Healthy control participants: Persons without low back pain during the experiment.
Participants with chronic low back pain: Persons with low back pain for at least three months.
Key exclusion criteria
History of spinal surgery
Neurological disorders
Difficulty in lifting due to lower back and lower limb injuries
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Chie |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4309
sekine@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Chie |
| Middle name | |
| Last name | Sekine |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
9503198
Address
1398 Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4309
Homepage URL
sekine@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Ethics Committee, Niigata University of Health and Welfare
Address
1398 Shimami-cho, Kita-ku, Niigata-shi, Niigata
Tel
025-257-4455
rinri@nuhw.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 | 05 | Month | 05 | 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
22
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
| 2021 | Year | 02 | Month | 18 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 20 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The title at the time of ethics review was " Analysis of trunk muscle activity and motion during lifting of objects -Examination in the with and without low back pain," which is different from the title at the time of registration.
Management information
Registered date
| 2022 | Year | 05 | Month | 05 | Day |
Last modified on
| 2022 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054340
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
