UMIN-CTR Clinical Trial

Basic information
Public title	Relationship between body position and lumbar muscle activity during getting up with or without a a jacket stimulating pregnancy for healthy women.
Acronym	Relationship between body position and lumbar muscle activity when getting up with or without a a jacket stimulating pregnancy for healthy women.
Scientific Title	Relationship between body position and lumbar muscle activity when getting up with or without a a jacket stimulating pregnancy for healthy women.
Scientific Title:Acronym	elationship between body position and lumbar muscle activity when getting up with or without a a jacket stimulating pregnancy for healthy women.
Region	Japan

Condition
Condition	Healthy adult women
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to clarify the relationship between lumbar muscle activity and lateral lying and rising postures in healthy adult women with and without a jacket stimulating pregnancy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of muscle activity in each position (supine, getting up, and sitting) in two conditions: with and without a jacket stimulating pregnancy.
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Three 5-second sessions of lying on the lying position, getting up, and sitting position, with and without a jacket stimulating pregnancy.
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	Health adult women
Key exclusion criteria	Cognitive disorders Movement disorders Sensory disorder
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Yui Middle name Last name Abe
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy Faculty of Health Sciences
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL	011-688-2305
Email	abe-y@hus.ac.jp

Public contact
Name of contact person	1st name Yui Middle name Last name Abe
Organization	Hokkaido University of Science
Division name	Department of Physical Therapy Faculty of Health Sciences
Zip code	006-8585
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
TEL	011-688-2305
Homepage URL
Email	abe-y@hus.ac.jp

Sponsor
Institute	Hokkaido University of Science
Institute
Department

Funding Source
Organization	Hokkaido University of Science
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	Hokkaido University of Science Ethics Committee
Address	7-15-4-1 Maeda, Teine, Sapporo, Hokkaido, JAPAN
Tel	011-688-2305
Email	011-688-2305

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	北海道科学大学

Other administrative information
Date of disclosure of the study information	2021 Year 06 Month 17 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	6
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 07 Month 01 Day
Date of IRB	2021 Year 05 Month 14 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2021 Year 12 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	2021 Year 06 Month 17 Day
Last modified on	2022 Year 04 Month 13 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050918