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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03921619
Other study ID # IRB-300002264
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2020
Est. completion date October 30, 2021

Study information

Verified date November 2021
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 30, 2021
Est. primary completion date July 31, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Greater than or equal to 65 years of age Exclusion Criteria: - Younger than 65 years of age - Pre-existing cognitive impairment - Pre-existing mobility impairment - Pre-existing symptomatic upper or lower extremity disease

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Shoulder Sling
soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder

Locations

Country Name City State
United States UAB Hospital Highlands Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
30 seconds
Primary Timed Up & Go Test Timed stand, walk, and sit test to assess mobility 30 seconds
Primary 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;
1 minute
Primary Sling / Fall Questionnaire General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire. 1 minute
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