Trial Outcomes & Findings for Rotator Cuff Tears in Hemiplegic Shoulder (NCT NCT00998868)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

51 participants

Primary outcome timeframe

within one month after enrollment

Results posted on

2011-09-30

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	Hemiplegia patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Rotator Cuff Tears in Hemiplegic Shoulder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hemiplegia n=51 Participants patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	24 Participants n=5 Participants
Age, Categorical >=65 years	27 Participants n=5 Participants
Age Continuous	63.37 years STANDARD_DEVIATION 10.765 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Region of Enrollment Korea, Republic of	51 participants n=5 Participants

PRIMARY outcome

Timeframe: within one month after enrollment

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.

Outcome measures

Outcome measures
Measure	Hemiplegia n=51 Participants patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography	29 participants

SECONDARY outcome

Timeframe: within one month after enrollment

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.

Outcome measures

Outcome measures
Measure	Hemiplegia n=51 Participants patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Rotator Cuff Tear of the Unaffected Shoulder, Confirmed by Ultrasonography	18 participants

SECONDARY outcome

Timeframe: within one month after enrollment

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.

Outcome measures

Outcome measures
Measure	Hemiplegia n=51 Participants patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Subluxation of the Glenohumeral Joint, Confirmed by Physical Examination	21 participants

SECONDARY outcome

Timeframe: within one month after enrollment

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.

Outcome measures

Outcome measures
Measure	Hemiplegia n=51 Participants patients with hemiplegia, without other musculoskeletal disorders of the shoulder
Muscle Strength, Measured by Physical Examination, Per Medical Research Council Muscle Strength Grading System	1.96 Units on a scale (minimum 0, maximum 5) Standard Deviation 1.442

Adverse Events

Hemiplegia

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tai Ryoon Han, MD, PhD./Professor

Seoul National University Hospital

Phone: +82-2-2072-3218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place