Sling Use and Functional Mobility in a Geriatric Population

Impact of Sling Use on Functional Mobility in a Geriatric Population

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.

Study Overview

• Status: Completed
• Conditions: Mobility Limitation
• Intervention / Treatment: Device: Shoulder Sling

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • UAB Hospital Highlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No Sling; Participants will perform the balance tests without any added equipment.
Experimental: Sling (Dominant); 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): October 30, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): November 9, 2021
• Last Update Submitted That Met QC Criteria: November 7, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: IRB-300002264

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No