UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032425
Receipt No. 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 2018/10/31

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Middle name
Last name Naoki Wada
Organization Gunma University Hospital
Division name Department of Rehabilitation Medicine
Zip code
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
Middle name
Last name Kazuhiro Takahashi
Organization Gunma University Hospital
Division name Department of Rehabilitation Medicine
Zip code
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
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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 05 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2018 Year 10 Month 31 Day


Link to view the page
URL(English) https://upload.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


Contact us.