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Sling Use and Functional Mobility in a Geriatric Population

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ClinicalTrials.gov Identifier: NCT03921619
Recruitment Status : Recruiting
First Posted : April 19, 2019
Last Update Posted : December 1, 2020
Sponsor:
Information provided by (Responsible Party):
Amit Momaya, University of Alabama at Birmingham

Study Description
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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.

Condition or disease Intervention/treatment Phase
Mobility Limitation Device: Shoulder Sling Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Sling Use on Functional Mobility in a Geriatric Population
Actual Study Start Date : February 15, 2020
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : December 30, 2021
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921619


Contacts
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Contact: Alexandra M Arguello, BS 702-375-4975 aarguello@med.unr.edu
Contact: Melanese Leonard-Warren, BSN, MSN, RN 205-975-2671 mnleonard@uabmc.edu

Locations
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United States, Alabama
UAB Hospital Highlands Recruiting
Birmingham, Alabama, United States, 35205
Contact: Amit Momaya, MD    205-930-8339    amomaya@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
More Information
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Responsible Party: Amit Momaya, Assistant Professor, Orthopaedic Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03921619    
Other Study ID Numbers: IRB-300002264
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: December 1, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Mobility Limitation