UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022090
Receipt number R000025440
Scientific Title The study of influences of shoulder sling on body functions and wearing feel.
Date of disclosure of the study information 2016/04/27
Last modified on 2018/02/27 22:35:48

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Basic information

Public title

The study of influences of shoulder sling on body functions and wearing feel.

Acronym

The study of shoulder sling.

Scientific Title

The study of influences of shoulder sling on body functions and wearing feel.

Scientific Title:Acronym

The study of shoulder sling.

Region

Japan


Condition

Condition

Rotater Cuff Injury

Classification by specialty

Orthopedics Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1)To investigate shoulder muscle tone, body alignment, body function with shoulder sling during rest and activity of daily living
2)To investigate the wearing feel and simplicity, stability, pain, and sleep with questionnaire survey

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The tension of shoulder muscle

Key secondary outcomes

Questionnaire survey
Basic information:Age, Height, Body weight, Sex
Medical information:disease, size and part of tear, radiographic image, pain


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Wearing shoulder sling Type A-B-A
One group wear sling A for 2 weeks after surgery, and sling B for 4 days, and sling A for 4 days.

Interventions/Control_2

Wearing shoulder sling Type B-A-B
Other group wear sling B for 2 weeks after surgery, and sling A for 4 days, and sling B for 4 days.

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

abc

Key exclusion criteria

1.People who had physical dysfunctions that may influence outcome measures, such as neurological impairment and musculoskeletal impairment except spine and shoulder disease.
2.People who have stand and gait disorder from neurological and internal medical disease.

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Ichihashi

Organization

Kyoto University

Division name

Human Health Sciences, Graduate School of Medicine

Zip code


Address

53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3951

Email

ichihashi.noriaki.5z@kyoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Noriaki Ichihashi

Organization

Kyoto University

Division name

Human Health Sciences, Graduate School of Medicine

Zip code


Address

53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto, Japan

TEL

075-751-3951

Homepage URL


Email

ichihashi.noriaki.5z@kyoto-u.ac.jp


Sponsor or person

Institute

Human Health Sciences, Graduate School of Medicine, Kyoto University

Institute

Department

Personal name



Funding Source

Organization

ALCARE INC.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

ALCARE INC.

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

京都大学医学部附属病院(京都府)


Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 27 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

Terminated

Date of protocol fixation

2016 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 05 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

2016 Year 04 Month 27 Day

Last modified on

2018 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025440


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name