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
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
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
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
