UMIN-CTR Clinical Trial

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
Institute	Gunma University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036976