UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000049153
Receipt number R000055992
Scientific Title Effect of Short foot exercise with ultrasound imaging bio-feedback on motor learning ~double blinded Randomaized control trial~
Date of disclosure of the study information 2022/10/07
Last modified on 2022/10/07 15:39:03

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Basic information

Public title

Effect of Short foot exercise with ultrasound imaging bio-feedback

Acronym

Effect of Short foot exercise with ultrasound imaging bio-feedback

Scientific Title

Effect of Short foot exercise with ultrasound imaging bio-feedback on motor learning ~double blinded Randomaized control trial~

Scientific Title:Acronym

Effect of Short foot exercise with ultrasound imaging bio-feedback on motor learning

Region

Japan


Condition

Condition

dysfunction of the foot

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to be clarified the efficacy of the short foot exercise with ultrasound bio-feedback

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

navicular height

Key secondary outcomes

Foot alignment in static standing and change of foot alignment during gait


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

ultrasound imaging biofeedback

Interventions/Control_2

verbal feedback

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

35 years-old >=

Gender

Male and Female

Key inclusion criteria

normal volunteers

Key exclusion criteria

/having pain
/ surgical history
/ having os tibiale externum

Target sample size

25


Research contact person

Name of lead principal investigator

1st name Shintarou
Middle name
Last name Kudo

Organization

Morinomiya university of medical sciences

Division name

Inclusive medical science research institute

Zip code

559-8611

Address

Nanko-kita,1-26-16, Suminoe ward

TEL

0666166911

Email

kudo@morinomiya-u.ac.jp


Public contact

Name of contact person

1st name Shintarou
Middle name
Last name Kudo

Organization

Morinomiya university of medical sciences

Division name

Research support center

Zip code

559

Address

Nanko-kita,1-26-16, Suminoe ward

TEL

0666166911

Homepage URL


Email

kudo@morinomiya-u.ac.jp


Sponsor or person

Institute

Morinomiya university of medical sciences

Institute

Department

Personal name



Funding Source

Organization

None

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

Morinomiya university of medical sciences

Address

Nanko-kita,1-26-16, Suminoe ward

Tel

0666166911

Email

shinsabukai@morinomiya-u.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 10 Month 07 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

Open public recruiting

Date of protocol fixation

2022 Year 08 Month 05 Day

Date of IRB

2022 Year 06 Month 30 Day

Anticipated trial start date

2022 Year 08 Month 11 Day

Last follow-up date

2022 Year 12 Month 20 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 10 Month 07 Day

Last modified on

2022 Year 10 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055992


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name