UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022295
Receipt number R000025688
Scientific Title Effects of insoles is given to the mechanical stress on the knee joint during walking and running
Date of disclosure of the study information 2016/05/13
Last modified on 2019/11/17 06:11:37

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Basic information

Public title

Effects of insoles is given to the mechanical stress on the knee joint during walking and running

Acronym

Effects of insoles is given to the mechanical stress on the knee joint during walking and running

Scientific Title

Effects of insoles is given to the mechanical stress on the knee joint during walking and running

Scientific Title:Acronym

Effects of insoles is given to the mechanical stress on the knee joint during walking and running

Region

Japan


Condition

Condition

Osteoarthritis of the knee
Sports injuries

Classification by specialty

Orthopedics Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

That the insoles to verify or give what kinematics, dynamics changes in the lower limb joint during walking and running

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lower extremity joint moments
Lower limb joint angle
Knee joint outside acceleration
Leg strength

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Prevention

Type of intervention

Other

Interventions/Control_1

insoles
Intervention period is 1 hour
Intervention number of times once

Interventions/Control_2

shoes
Intervention period is 1 hour
Intervention number of times once

Interventions/Control_3

lateral wedged insoles
Intervention period is 1 hour
Intervention number of times once

Interventions/Control_4

medial wedged insoles
Intervention period is 1 hour
Intervention number of times once

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

The person can be 10m walking

Key exclusion criteria

A person who has a musculoskeletal disease and neurological disease in history
Those who can not understand the description of the present study
And those who can not be obtained the consent

Target sample size

36


Research contact person

Name of lead principal investigator

1st name Kazuhiro
Middle name
Last name Kazuhiro

Organization

Matsumoto Hospital,Hyogo,Japan

Division name

Department of Rehabilitation

Zip code

675-0039

Address

KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan

TEL

079-424-0333

Email

zipputanaka@gmail.com


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Kazuhiro

Organization

Matsumoto Hospital,Hyogo,Japan

Division name

Department of Rehabilitation

Zip code

675-0039

Address

KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan

TEL

079-424-0333

Homepage URL


Email

zipputanaka@gmail.com


Sponsor or person

Institute

Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan

Institute

Department

Personal name



Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Department of Physical Therapy, Faculty of Health Science, Kio University, Nara, Japan

Name of secondary funder(s)

Takahiko Fukumoto


IRB Contact (For public release)

Organization

Matsumoto Hospital

Address

KakogawachoAwazu 232-1 Kakogawa,Hyogo Japan

Tel

079-424-0333

Email

zipputanaka@gmail.com


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

2016 Year 05 Month 13 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

12

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

2016 Year 05 Month 14 Day

Date of IRB

2016 Year 03 Month 31 Day

Anticipated trial start date

2016 Year 05 Month 15 Day

Last follow-up date

2019 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

2016 Year 05 Month 12 Day

Last modified on

2019 Year 11 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025688


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name