Sling Use and Functional Mobility in a Geriatric Population

Mobility Limitation Clinical Trial

Official title:

Impact of Sling Use on Functional Mobility in a Geriatric Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921619
• Other study ID #: IRB-300002264
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mobility Limitation

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