An interventional study of Shoulder Sling in Mobility Limitation, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-09.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Other
Shoulder slings are commonly worn after shoulder surgery. In geriatric patients, painstaking care is taken to reduce any factors that may increase the chance of experiencing a fall. Currently, it is not understood if wearing a sling affects someone's general gait and balance.
Following many shoulder operations, patients are immobilized in an bulky sling with non-weight bearing restrictions for periods of up to 6 weeks. This is necessary to allow for soft tissue healing particularly following repair of rotator cuff tears and shoulder replacement surgeries, two common procedures performed in the elderly population. Previous studies have shown that natural arm swing plays an essential role in maintaining balance and normal gait patterns. Decreased functional mobility and gait impairment has been shown to increase the risk of falls, mortality, and morbidity in an elderly population. However, following upper extremity surgery requiring the use of a sling, targeted therapy for gait and balance training is rarely prescribed. Consequently, the investigators wish to assess whether or not sling use impacts functional mobility test scores in an elderly population. The aim of this project is to maximize perioperative functionality in these patients in efforts to prevent any unanticipated secondary injury.
317 studies on the registry are indexed under Mobility Limitation; 97 are open to participants now.
This study's enrollment of 50 is close to the median of 46 across 265 interventional studies indexed under Mobility Limitation.
Browse Mobility Limitation studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will perform the balance tests without any added equipment.
Participants will perform the balance tests with a sling on the dominant arm.
Device: Shoulder Sling
soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder
Tinetti Test
Performance-oriented mobility assessment: Components are balance \& gait. Patient will be seated in a hard, armless chair and be assessed for balance with all of the following: sitting balance, rising from chair, attempting to rise, immediate standing balance (first 5 sec), standing balance, balance while being nudged, balance with eyes closed, turning 360 degrees, and sitting down. Scored out of 16. The gait portion assesses hesitancy, step length \& height, foot clearance, step symmetry, step continuity, path, trunk, and walking time. Scored out of 12. Total score out of 28. If score is ≤18, risk of falls is high. If score is 19-23, risk of falls is moderate. If score is ≥24, risk of falls is low.
Time frame: 30 seconds
Timed Up & Go Test
Timed stand, walk, and sit test to assess mobility
Time frame: 30 seconds
Edmonton Frail Scale
Global assessment of patient vulnerability: Domains to be assessed are cognition (clock drawing), general health status (hospitalizations in last year \& describing own health), functional independence (how many ADL's require help), social support, medication use (5 or more on a regular basis, adherence to regimen), nutrition (weight loss), mood, continence, and functional performance (timed rising from chair and walking). Scored out of 17, higher scores associated with higher frailty. Scoring : 0 - 5 = Not Frail; 6 - 7 = Vulnerable; 8 - 9 = Mild Frailty; 10-11 = Moderate Frailty; 12-17 = Severe Frailty;
Time frame: 1 minute
Sling / Fall Questionnaire
General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire.
Time frame: 1 minute
Plan to share: No
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This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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University of Alabama at Birmingham