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Rotator Cuff Tears in Hemiplegic Shoulder

Observational Study to Evaluate the Prevalence of Rotator Cuff Tears in Hemiplegic Shoulders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00998868
Enrollment
51
Registered
2009-10-21
Start date
2008-01-31
Completion date
2010-08-31
Last updated
2011-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemiplegia

Keywords

Rotator Cuff, Tendinopathy, ultrasonography

Brief summary

The purpose of the study is to evaluate the prevalence of rotator cuff tears in the shoulders of hemiplegic patients of different severity.

Detailed description

Rotator cuff tears are often suspected to contribute hemiplegic shoulder pain. However, it is controversial whether their incidence increases in hemiplegia. Based on the postulate that muscle weakness in hemiplegia predisposes rotator cuff injury due to biomechanical failure, this study aims to investigate whether the rotator cuff tears are associated with the muscle strength of the shoulder by observing hemiplegic shoulders of varying degree of paresis.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* hemiplegia; unilateral weakness of sudden onset * secondary to strokes or other brain lesions * compatible with brain lesions confirmed by imaging studies

Exclusion criteria

* bilateral weakness * any history of intensive trauma of the shoulder, reported * preexisting musculoskeletal disorder of the shoulder

Design outcomes

Primary

MeasureTime frameDescription
Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonographywithin one month after enrollmentAll patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.

Secondary

MeasureTime frameDescription
Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonographywithin one month after enrollmentAll patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.
Subluxation of the Glenohumeral Joint, Confirmed by Physical Examinationwithin one month after enrollmentThe glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.
Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading Systemwithin one month after enrollmentMuscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group. MRC scale: Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement.

Countries

South Korea

Participant flow

Recruitment details

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

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.

Participants by arm

ArmCount
Hemiplegia
patients with hemiplegia, without other musculoskeletal disorders of the shoulder
51
Total51

Baseline characteristics

CharacteristicHemiplegia
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
27 Participants
Age, Categorical
Between 18 and 65 years
24 Participants
Age Continuous63.37 years
STANDARD_DEVIATION 10.765
Region of Enrollment
Korea, Republic of
51 participants
Sex: Female, Male
Female
26 Participants
Sex: Female, Male
Male
25 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 51
serious
Total, serious adverse events
0 / 51

Outcome results

Primary

Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography

All patients underwent ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.

Time frame: within one month after enrollment

ArmMeasureValue (NUMBER)
HemiplegiaRotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography29 participants
Secondary

Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System

Muscle strength was measured for forward flexion and abduction of the shoulder per Medical Research Council (MRC) scale in each participants. Their mean +/- SD were calculated in each group. MRC scale: Grade 5: Normal and can move against full resistance. Grade 4: Reduced but can move against resistance. Grade 3: Can move only against gravity Grade 2: Can move without gravity Grade 1: Only a trace of movement Grade 0: No movement.

Time frame: within one month after enrollment

ArmMeasureValue (MEAN)Dispersion
HemiplegiaMuscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System1.96 Units on a scale (minimum 0, maximum 5)Standard Deviation 1.442
Secondary

Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography

All patients were performed ultrasonography (USG) for the both, affected and unaffected, shoulders. USG routinely examined biceps, subscapularis, supraspinatus, and infraspinatus tendons as for the partial or complete tears, calcifications, bony irregularity and bursal swellings.

Time frame: within one month after enrollment

ArmMeasureValue (NUMBER)
HemiplegiaRotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography18 participants
Secondary

Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination

The glenohumeral joint subluxation was examined by palpating the subacromial regions of the both sides and comparing the affected side with the unaffected side while patients are seated and relaxed. If the palpated space between the acromion and the humeral head was wider on the affected side by one half finger breath or more, it was judged to be subluxation.

Time frame: within one month after enrollment

ArmMeasureValue (NUMBER)
HemiplegiaSubluxation of the Glenohumeral Joint, Confirmed by Physical Examination21 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026