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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044238
Receipt No. R000050512
Scientific Title Immediate effects of pressure and ultrasound biofeedback in core training in asymptomatic individuals: crossover trial
Date of disclosure of the study information 2021/05/18
Last modified on 2021/11/19

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Basic information
Public title Immediate effects of pressure and ultrasound biofeedback in core training in asymptomatic individuals: crossover trial
Acronym Clinical study of feedback effects in core training in asymptomatic individuals
Scientific Title Immediate effects of pressure and ultrasound biofeedback in core training in asymptomatic individuals: crossover trial
Scientific Title:Acronym Clinical study of feedback effects in core training in asymptomatic individuals
Region
Japan

Condition
Condition asymptomatic individuals
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the pressure biofeedback effect when asymptomatic individuals perform abdominal draw-in maneuver (ADIM) which is a type of core training, with the ultrasound biofeedback effect
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum transversus abdominis muscle thickness in ADIM with biofeedback after training (measured by ultrasound)
Key secondary outcomes Resting transversus abdominis muscle thickness (measured by ultrasound)
Resting external oblique muscle thickness and maximum external oblique muscle thickness in ADIM after training (measured by ultrasound)
Resting internal oblique muscle thickness and maximum internal oblique muscle thickness in ADIM after training (measured by ultrasound)
Preferential activation ratio
Waist circumference at iliac crest level

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 pressure biofeedback: 10 minutes
Interventions/Control_2 ultrasound biofeedback: 10 minutes
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Being a staff member of Keio University School of Medicine or Keio University Hospital
To eliminate bias, ages under 40 and over 40 are recruited in the range 4: 6 to 6: 4, and genders are recruited in the range 4: 6 to 6: 4 for men and women
Asymptomatic individuals
Those who understand the research content and obtain informed consent
Key exclusion criteria Contraindicated cases of exercise therapy
Cases with a history of lumbar spine disease
Cases with a history of neuromuscular disease
Cases with a history of abdominal / lumbar surgery
Pregnant women
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Aiko
Middle name
Last name Ishikawa
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 160-8582
Address 35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL 03-5363-3833
Email aishi@keio.jp

Public contact
Name of contact person
1st name Aiko
Middle name
Last name Ishikawa
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code 160-8582
Address 35 Shinanomachi Shinjyuku-ku Tokyo, Japan
TEL 03-5363-3833
Homepage URL
Email aishi@keio.jp

Sponsor
Institute Keio University School of Medicine
Department of Rehabilitation Medicine
Institute
Department

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 Keio University School of Medicine, Faculty of Medicine Ethics Committee
Address 35 Shinanomachi Shinjyuku-ku Tokyo, Japan
Tel 03-3353-1211
Email med-rinri-jimu@adst.keio.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
2021 Year 05 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 Enrolling by invitation
Date of protocol fixation
2021 Year 05 Month 09 Day
Date of IRB
2021 Year 05 Month 10 Day
Anticipated trial start date
2021 Year 05 Month 29 Day
Last follow-up date
2023 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 05 Month 18 Day
Last modified on
2021 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050512

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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