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OpenTrials
Completed

NCT Number: NCT03921619

Sling Use and 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.

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Key information

Conditions

Mobility Limitation Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shoulder Sling

Device

soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder

Primary outcomes

  1. Tinetti Test

    Time frame: 30 seconds

    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.

  2. Timed Up & Go Test

    Time frame: 30 seconds

    Timed stand, walk, and sit test to assess mobility

  3. Edmonton Frail Scale

    Time frame: 1 minute

    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;

  4. Sling / Fall Questionnaire

    Time frame: 1 minute

    General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Impact of Sling Use on Functional Mobility in a Geriatric Population

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2019
Registry last updated
Nov 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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