UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030318
Receipt number R000034616
Scientific Title Effect of age, handedness and use of compression wear on knee joint proprioceptive target matching asymmetries
Date of disclosure of the study information 2017/12/08
Last modified on 2019/01/03 22:54:13

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Basic information

Public title

Effect of age, handedness and use of compression wear on knee joint proprioceptive target matching asymmetries

Acronym

Compression wear effect on knee joint proprioception asymmetries

Scientific Title

Effect of age, handedness and use of compression wear on knee joint proprioceptive target matching asymmetries

Scientific Title:Acronym

Compression wear effect on knee joint proprioception asymmetries

Region

Japan


Condition

Condition

healthy

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The primary objectives of this study are
to investigate the effect of handedness,age and a compression wear would affect proprioceptive target matching accuracy of the knee.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Knee joint target matching accuracy

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

Compression wear

Interventions/Control_2


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

70 years-old >

Gender

Male and Female

Key inclusion criteria

1) Healthy
2) 20 years old or older and younger than 40 and left handed up to 12 subjects; 20 years old or older and younger than 40 and right handed up to 12 subjects;50 years old or older and younger than 70 and left handed up to 12 subjects;50 years old or older and younger than 70 and right handed up to 12 subjects.
3) has given informed consent

Key exclusion criteria

Knee joint injury or disability
Skin infection
Disabled motor function

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryoichi Nagatomi

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code


Address

Seiryo-cho 2-1, Aoba-ku, Sendai, Japan

TEL

022-717-8586

Email

nagatomi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoichi Nagatomi

Organization

Tohoku University

Division name

Graduate School of Biomedical Engineering

Zip code


Address

Seiryo-cho 2-1, Aoba-ku, Sendai, Japan

TEL

022-717-8586

Homepage URL


Email

nagatomi@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Graduate School of Biomedical Engineering

Institute

Department

Personal name



Funding Source

Organization

Tohoku University Graduate School of Biomedical Engineering

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

東北大学(宮城県)


Other administrative information

Date of disclosure of the study information

2017 Year 12 Month 08 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.ncbi.nlm.nih.gov/pubmed/30180187

Number of participants that the trial has enrolled


Results

CG did not reduce passive joint position sense errors. Joint position error was less (more accurate) without CG (p = 0.014).

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

Completed

Date of protocol fixation

2017 Year 12 Month 08 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 08 Day

Last follow-up date

2018 Year 02 Month 02 Day

Date of closure to data entry

2018 Year 02 Month 02 Day

Date trial data considered complete

2018 Year 02 Month 09 Day

Date analysis concluded

2018 Year 03 Month 10 Day


Other

Other related information



Management information

Registered date

2017 Year 12 Month 08 Day

Last modified on

2019 Year 01 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034616


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name