Viewing Study NCT04181450


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Study NCT ID: NCT04181450
Status: UNKNOWN
Last Update Posted: 2019-11-29
First Post: 2019-11-25
Is Possible Gene Therapy: False
Has Adverse Events: False

Brief Title: Biodex Balance System Cut-off Scores in Geriatric Individuals
Sponsor: Hacettepe University
Organization:

Study Overview

Official Title: Biodex Balance System Cut-off Scores in Geriatric Individuals With Non-Specific Low Back Pain
Status: UNKNOWN
Status Verified Date: 2019-11
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Low back pain (LBP) is an important musculoskeletal problem that causes clinical, social and economic losses. LBP, which affects approximately 85% of the lifetime population, becomes chronic LBP in 23% of individuals lasting 3 months or more. Although there are various forms of LBP, the most common form is non-specific low back pain (NSLBP). There are no specific and definable pathologies in NSLBP such as a history of spinal surgery, presence of neurological deficit, facet joint problem, disc herniation and sacroiliac joint dysfunction.

Biodex Balance System (Biodex Medical Systems, Shirley, NY) (BBS) is a device used for objective evaluation of static and dynamic balance, allowing free movement in mediolateral and anteroposterior directions. The validity-reliability studies of the BBS were conducted in various populations including active, non-active, young adult and geriatric individuals, and individuals with ankle sprains. The validity-reliability study of individuals with NSLBP was reported by Sherafat et al. has a strong-excellent correlation with four-square step test, timed-up-and-go test, Berg Balance Scale, and single leg stance test.

Studies have emphasized the use of BBS in geriatric individuals with NSLBP, but no data on the cut-off scores of this system have been found. The determination of a cut-off score with high sensitivity and specificity is thought to be beneficial for detecting deterioration in functional status in geriatric individuals with NSLBP. Therefore, the aim of our study is to determine BBS cut-off scores in geriatric individuals with NSLBP.
Detailed Description: Low back pain (LBP) is an important musculoskeletal problem that causes clinical, social and economic losses. LBP, which affects approximately 85% of the lifetime population, becomes chronic LBP in 23% of individuals lasting 3 months or more. Although there are various forms of LBP, the most common form is non-specific low back pain (NSLBP). There are no specific and definable pathologies in NSLBP such as a history of spinal surgery, presence of neurological deficit, facet joint problem, disc herniation and sacroiliac joint dysfunction.

Although there are studies examining the changes in various positions in geriatric individuals with NSLBP, maintaining and maintaining postural control during standing position has been the focus of current studies. According to the systematic review study on the effect of sensory manipulations on postural release changes in individuals with NSLBP, the results are uncertain and further studies are needed. For example, in cases where sensory systems (eg visual, proprioceptive, and vestibular) that are effective in achieving postural control are not manipulated, some studies report greater release size in NSLBP patients, while others find that the size of release is similar to healthy individuals. Sherafat et al. Emphasized that the evaluation of gravity center changes in static environment may be effective in the emergence of these contradictory results. As expressed in this study, standing still on a static platform may be an obstacle to detect small postural stability and balance differences between individuals with and without NSLBP. In this context, testing of geriatric individuals with NSLBP in the standing position on a mobile platform such as the Biodex Balance System (BBS) (Biodex Medical Systems, Shirley, NY) and exposure to more stringent equilibrium conditions will yield more sensitive results in assessing postural stability and balance.

BBS is a device used for objective evaluation of static and dynamic balance, allowing free movement in mediolateral and anteroposterior directions. The validity-reliability studies of the BBS were conducted in various populations including active, non-active, young adult and geriatric individuals, and individuals with ankle sprains. The validity-reliability study of individuals with NSLBP was reported by Sherafat et al. has a strong-excellent correlation with four-square step test, timed-up-and-go test, Berg Balance Scale, and single leg stance test.

Studies have emphasized the use of BBS in geriatric individuals with NSLBP, but no data on the cut-off scores of this system have been found. The determination of a cut-off score with high sensitivity and specificity is thought to be beneficial for detecting deterioration in functional status in geriatric individuals with NSLBP. Therefore, the aim of our study is to determine BBS cut-off scores in geriatric individuals with NSLBP.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: