UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032425
Receipt number R000036976
Scientific Title Shoulder proprioception after rotator cuff tear related to motor function: A pilot study
Date of disclosure of the study information 2018/05/15
Last modified on 2020/11/04 22:35:01

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Basic information

Public title

Shoulder proprioception after rotator cuff tear related to motor function: A pilot study

Acronym

Influence of shoulder proprioception after rotator cuff tear

Scientific Title

Shoulder proprioception after rotator cuff tear related to motor function: A pilot study

Scientific Title:Acronym

Influence of shoulder proprioception after rotator cuff tear

Region

Japan


Condition

Condition

Rotator cuff tear

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the variation of proprioception with health subject and rotator cuff tear

Basic objectives2

Others

Basic objectives -Others

To clarify whether the proprioception of the rotator cuff tear patient affects the active range of motion

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

position sense, kinesthesia as proprioception

Key secondary outcomes

Pain, Active range of motion of shoulder joint, strength of shoulder joint


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

50 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) healthy subjects in their 50s to 70s without neurologic or orthopaedic disorders
2) patients with unilateral rotator cuff tear before arthroscopic rotator cuff repair

Key exclusion criteria

1) a shoulder joint disease on the nonoperative shoulder
2) strong pain
3) less than 60 degree of glenohumeral abduction or 30 degree of glenohumeral external rotation
4) reproduction of symptoms during a cervical screening examination
5) numbness or tingling in the upper extremity
6) a history of shoulder joint surgery

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Naoki
Middle name
Last name Wada

Organization

Gunma University Hospital

Division name

Department of Rehabilitation Medicine

Zip code

371-8511

Address

3-39-15, Showamachi, Maebashi, Gunma, Japan

TEL

027-220-8532

Email

nwada@gunma-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Takahashi

Organization

Gunma University Hospital

Division name

Department of Rehabilitation Medicine

Zip code

371-8511

Address

3-39-15, Showamachi, Maebashi, Gunma, Japan

TEL

027-220-8532

Homepage URL


Email

taka1983@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

Gunma University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Department of clinical examination, Gunma University Hospital

Address

3-39-15 Showa, Maebashi, Gunma

Tel

027-220-8740

Email

hitotaisho-ciru@ml.gunma-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

2018 Year 05 Month 15 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

23

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

Completed

Date of protocol fixation

2018 Year 05 Month 15 Day

Date of IRB

2018 Year 05 Month 01 Day

Anticipated trial start date

2018 Year 05 Month 15 Day

Last follow-up date

2020 Year 11 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2020 Year 11 Month 04 Day


Other

Other related information

From May 15, 2018 to March 31, 2021, subjects receive explanation about the outline of the research from their physical therapist. The researcher in charge explains the details of the research to the subjects who show interest to participation. Subjects decide accept the participation or not by free will.


Management information

Registered date

2018 Year 04 Month 29 Day

Last modified on

2020 Year 11 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036976


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name