UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044238 |
|---|---|
| Receipt number | 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 | 2024/01/06 11:31:52 |
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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
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
aishi@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Department of Rehabilitation Medicine
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
Keio University School of Medicine, Faculty of Medicine Ethics Committee
Address
35 Shinanomachi Shinjyuku-ku Tokyo, Japan
Tel
03-3353-1211
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
24
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
No longer recruiting
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
| 2025 | 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
| 2024 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050512
