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
|Condition or disease||Intervention/treatment||Phase|
|Mobility Limitation||Device: Shoulder Sling||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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
- 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.
- Timed Up & Go Test [ Time Frame: 30 seconds ]Timed stand, walk, and sit test to assess mobility
- 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;
- Sling / Fall Questionnaire [ Time Frame: 1 minute ]General questions about sling use and experiencing a fall. There is no scale associated with this questionnaire.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921619
|Contact: Alexandra M Arguello, BSfirstname.lastname@example.org|
|Contact: Melanese Leonard-Warren, BSN, MSN, RNemail@example.com|
|United States, Alabama|
|UAB Hospital Highlands||Recruiting|
|Birmingham, Alabama, United States, 35205|
|Contact: Amit Momaya, MD 205-930-8339 firstname.lastname@example.org|