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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name