Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06289088
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-02-26
Brief Title:
The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance
Sponsor:
Istanbul Medipol University Hospital
Organization:
Istanbul Medipol University Hospital
Study Overview
Official Title:
The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
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:
lumbosacral
Brief Summary:
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain comfort plantar pressure static and dynamic balance in individuals with low back pain
Detailed Description:
The aim of this study is to examine the effect of steel underwire lumbosacral orthosis adapted to the individual by the prosthetist orthotist on pain comfort plantar pressure static and dynamic balance in individuals with low back pain Thirty male and female volunteers between the ages of 18-65 who came to Istanbul Medipol University Prosthesis Orthotics Center and experienced low back pain were included in the study
The study will be designed as Crossover The study consists of three methods and a single group which are orthosis-free worn by a person with low back pain and adapted by a prosthetist orthotist Following both orthosis insertion methods pain severity will be measured with Visual Analogue Scale VAS and comfort level was measured with Orthosis Comfort Score They will be asked to wait for 30 minutes with orthosis and then the pain severity and comfort level were measured again Y Balance Test YBT and Functional Reach Test FRT will be used for dynamic balance Plantar pressure and static balance will be analyzed with pedobarography device Static Pressure and stabilometric data will be found
The study will be designed as Crossover The study consists of three methods and a single group which are orthosis-free worn by a person with low back pain and adapted by a prosthetist orthotist Following both orthosis insertion methods pain severity will be measured with Visual Analogue Scale VAS and comfort level was measured with Orthosis Comfort Score They will be asked to wait for 30 minutes with orthosis and then the pain severity and comfort level were measured again Y Balance Test YBT and Functional Reach Test FRT will be used for dynamic balance Plantar pressure and static balance will be analyzed with pedobarography device Static Pressure and stabilometric data will be found
Study Oversight
Has Oversight DMC:
None
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?:
None