NCT06289088

The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance

The Effect of an Individually Adapted Lumbosacral Orthosis on Plantar Pressure and Balance in Individuals With Low Back Pain

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Istanbul Medipol University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Orthosis
• Low Back Pain, Postural

Interventions

Type	Name	Description
OTHER	First Intervention	Firstly, For individuals with low back pain, all measurements will be evaluated without wearing any orthosis. The waist circumference of individuals with low back pain will be measured and the orthosis was adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the measurements will be repeated. Then, the person will be asked to wear the orthosis without any intervention.
OTHER	Second Intervention	Firstly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be repeated. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis.
OTHER	Third Intervention	Firstly, the person will be asked to wear the orthosis without any intervention and the outcome measurements will be done. The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotist. After waiting with the orthosis for half an hour, all measurements will be evaluated without wearing any orthosis. Lastly, The waist circumference of individuals with low back pain will be measured and the orthosis will be adapted to the appropriate orthosis size by the prosthetist orthotis. After waiting with the orthosis for half an hour, all measurements will be evaluated.

Timeline

• Start date: 2024-03-04
• Primary completion: 2024-05-04
• Completion: 2024-05-04
• First posted: 2024-03-01
• Last updated: 2024-03-19

Locations

1 site across 1 country: Turkey (Türkiye)