UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030048
Receipt number R000034313
Scientific Title efficacy of exercise shoulder brace for preventing contracture
Date of disclosure of the study information 2017/11/20
Last modified on 2018/11/22 15:52:02

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Basic information

Public title

efficacy of exercise shoulder brace for preventing contracture

Acronym

efficacy of exercise shoulder brace

Scientific Title

efficacy of exercise shoulder brace for preventing contracture

Scientific Title:Acronym

efficacy of exercise shoulder brace

Region

Japan


Condition

Condition

normal volunteers

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to analyze the efficacy of new exercise shoulder brace

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the angle rotation of humeral and scapula

Key secondary outcomes

the position of the center of humeral head
alignment of the spine


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

The volunteers are requested to equip shoulder brace for 30 minutes and to conduct MRI.

Interventions/Control_2

More than 1 week later, they are also requested to equip new shoulder brace for 30 minutes and to conduct MRI again.

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

healthy normal person

Key exclusion criteria

person who have disability in shoulder

Target sample size

18


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshihiro Hagiwara

Organization

Tohoku university

Division name

Department of orthopaedic surgery

Zip code


Address

1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi

TEL

022-717-7248

Email

hagi@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshihiro Hagiwara

Organization

Tohoku university

Division name

Department of orthopaedic surgery

Zip code


Address

1-1, Seiryomachi, Aoba-ku, Sendai, Miyagi

TEL

022-717-7248

Homepage URL


Email

hagi@med.tohoku.ac.jp


Sponsor or person

Institute

Department of Orthopaedic Surgery, Tohoku university Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Orthopaedic Surgery, Tohoku university Graduate School of Medicine

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2017 Year 11 Month 20 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

2017 Year 11 Month 20 Day

Date of IRB


Anticipated trial start date

2017 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2017 Year 11 Month 20 Day

Last modified on

2018 Year 11 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name