Rotator Cuff Tears in Hemiplegic Shoulder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sun Gun Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00998868
First received: October 20, 2009
Last updated: September 23, 2011
Last verified: September 2011
Results First Received: August 15, 2010  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition: Hemiplegia

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment period: Jan, 2008 - Dec, 2009 Recruitment site: Seoul National University Eligible canditates from: inpatients in the department of rehabilitation medicine of the hospital Methods of recruitment: research physicians informed about the study to all eligible candidates and asked if they agreed to participate.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study was designed to recruit hemiplegic patients of diverse degree of paresis with the same size. Because the crude distribution of the motor weakness was not even, the recruitment process adjusted the distribution of the severity of paresis, by recruiting patients of different motor strength in a consecutive way.

Reporting Groups
  Description
Hemiplegia patients with hemiplegia, without other musculoskeletal disorders of the shoulder

Participant Flow:   Overall Study
    Hemiplegia  
STARTED     51 [1]
COMPLETED     51  
NOT COMPLETED     0  
[1] >=10 for each muscle strength per MRC scale, after excluding the cases following exclusion criteria



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Hemiplegia patients with hemiplegia, without other musculoskeletal disorders of the shoulder

Baseline Measures
    Hemiplegia  
Number of Participants  
[units: participants]
  51  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     24  
>=65 years     27  
Age  
[units: years]
Mean ± Standard Deviation
  63.37  ± 10.765  
Gender  
[units: participants]
 
Female     26  
Male     25  
Region of Enrollment  
[units: participants]
 
Korea, Republic of     51  



  Outcome Measures
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1.  Primary:   Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography   [ Time Frame: within one month after enrollment ]

2.  Secondary:   Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography   [ Time Frame: within one month after enrollment ]

3.  Secondary:   Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination   [ Time Frame: within one month after enrollment ]

4.  Secondary:   Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System   [ Time Frame: within one month after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Tai Ryoon Han, MD, PhD./Professor
Organization: Seoul National University Hospital
phone: +82-2-2072-3218
e-mail: tairyoon@snu.ac.kr


Publications:


Responsible Party: Sun Gun Chung, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00998868     History of Changes
Other Study ID Numbers: SNUH-RM-TRHan-RCTHS-01
Study First Received: October 20, 2009
Results First Received: August 15, 2010
Last Updated: September 23, 2011
Health Authority: Korea: Food and Drug Administration
Korea: Ministry for Health, Welfare and Family Affairs