Sling Use and Functional Mobility in a Geriatric Population
Primary Purpose
Mobility Limitation
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shoulder Sling
Sponsored by
About this trial
This is an interventional other trial for Mobility Limitation
Eligibility 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
Sites / Locations
- UAB Hospital Highlands
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Sling
Sling (Dominant)
Arm Description
Participants will perform the balance tests without any added equipment.
Participants will perform the balance tests with a sling on the dominant arm.
Outcomes
Primary Outcome Measures
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.
Timed Up & Go Test
Timed stand, walk, and sit test to assess mobility
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;
Sling / Fall Questionnaire
General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire.
Secondary Outcome Measures
Full Information
NCT ID
NCT03921619
First Posted
April 16, 2019
Last Updated
November 7, 2021
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03921619
Brief Title
Sling Use and Functional Mobility in a Geriatric Population
Official Title
Impact of Sling Use on Functional Mobility in a Geriatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
October 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mobility Limitation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Sling
Arm Type
No Intervention
Arm Description
Participants will perform the balance tests without any added equipment.
Arm Title
Sling (Dominant)
Arm Type
Experimental
Arm Description
Participants will perform the balance tests with a sling on the dominant arm.
Intervention Type
Device
Intervention Name(s)
Shoulder Sling
Intervention Description
soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder
Primary Outcome Measure Information:
Title
Tinetti Test
Description
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.
Time Frame
30 seconds
Title
Timed Up & Go Test
Description
Timed stand, walk, and sit test to assess mobility
Time Frame
30 seconds
Title
Edmonton Frail Scale
Description
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;
Time Frame
1 minute
Title
Sling / Fall Questionnaire
Description
General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire.
Time Frame
1 minute
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
UAB Hospital Highlands
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Sling Use and Functional Mobility in a Geriatric Population
We'll reach out to this number within 24 hrs