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Sling Use and Functional Mobility in a Geriatric Population

NCT ID: NCT03921619

Last Updated: 2021-11-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2021-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mobility Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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No Sling

Participants will perform the balance tests without any added equipment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Sling (Dominant)

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

Group Type EXPERIMENTAL

Shoulder Sling

Intervention Type DEVICE

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

Interventions

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Shoulder Sling

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Amit Momaya

Assistant Professor, Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UAB Hospital Highlands

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300002264

Identifier Type: -

Identifier Source: org_study_id