Sling Use and Functional Mobility in a Geriatric Population

NCT03921619 | Completed

• 1 other identifier: IRB-300002264
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mobility Limitation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

No Sling

NO INTERVENTION

Participants will perform the balance tests without any added equipment.

Sling (Dominant)

EXPERIMENTAL

Participants will perform the balance tests with a sling on the dominant arm.

Device: Shoulder Sling

Interventions

Shoulder Sling DEVICE

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

Sling (Dominant)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Greater than or equal to 65 years of age

You may not qualify if:

• Younger than 65 years of age
• Pre-existing cognitive impairment
• Pre-existing mobility impairment
• Pre-existing symptomatic upper or lower extremity disease

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Hospital Highlands

Birmingham, Alabama, 35205, United States

Location

MeSH Terms

Conditions

Mobility Limitation

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Orthopaedic Surgery

Model Details: Participants will be asked to perform two balance assessments (Tinetti Balance Scale, Get Up and Go Test) while: 1) not wearing a sling; and 2) wearing a sling on the dominant arm. Additional data will be collected regarding patient frailty with the Edmonton Frail Scale, as well as data regarding sling use and falls in the form of a questionnaire.

Study Record Dates

• First Submitted: April 16, 2019
• First Posted: April 19, 2019
• Study Start: February 15, 2020
• Primary Completion: July 31, 2021
• Study Completion: October 30, 2021
• Last Updated: November 9, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)