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Sling Use and Functional Mobility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03921619
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : April 19, 2019
Information provided by (Responsible Party):
Amit Momaya, University of Alabama at Birmingham

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 sling wear, 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 with the objective of maximize perioperative functionality in these patients in efforts to prevent any unanticipated secondary injury

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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; 2) wearing a sling on the dominant arm; 3) wearing a sling on the non-dominant arm.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Impact of Sling Use on Functional Mobility in a Geriatric Population
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
No Intervention: No Sling
Participants will peform 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

Experimental: Sling (Non-Dominant)
Participants will perform the balance tests with a sling on the non-dominant arm.
Device: Shoulder Sling
soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder

Primary Outcome Measures :
  1. Tinetti Test [ Time Frame: 30 seconds ]
    Performance-oriented mobility assessment

  2. Timed Up & Go Test [ Time Frame: 30 seconds ]
    Timed stand, walk, and sit test

  3. Edmonton Frail Scale [ Time Frame: 1 minute ]
    Global assessment of patient vulnerability

  4. Sling / Fall Questionnairre [ Time Frame: 1 minute ]
    General questions about slings use and experiencing a fall

Information from the National Library of Medicine

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

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

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Responsible Party: Amit Momaya, Assistant Professor, Orthopaedic Surgery, University of Alabama at Birmingham Identifier: NCT03921619     History of Changes
Other Study ID Numbers: IRB-300002264
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
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
Signs and Symptoms