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临床试验/NCT06170112
NCT06170112招募中不适用

Evaluation Of The Effect Of Spinal Orthosis On Tactile Sense And Balance In Individuals With Lumbal Curve And Adolescent Idiopathic Scoliosis

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年11月13日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
1
主要终点
The effect of spinal orthosis on the sense of touch

研究概览

简要总结

In individuals with lumbar curvature, significant regressions in the curvature have been observed with spinal orthosis treatment, especially with use of a minimum of 20 hours a day. Symptoms such as numbness and decreased sense of touch are observed in the areas where the curvature is located, and changes in the skin structure are affected by the changes in the spine. Sensory testing may vary with changes in body posture. At the same time, the use of spinal orthosis, balance, fat mass, and the presence of pain show us sensitivity to touch on the skin. Sensory stimuli on the skin and trunk posture are interconnected. There are a limited number of studies in the literature examining the effects of sensory test results and fat mass on individuals diagnosed with AIS after using a spinal orthosis.

详细描述

The purpose of this study is to examine how spinal orthoses affect lumbar curvature, tactile sensation, dynamic balance, skinfold thickness, and quality of life in people with adolescent idiopathic scoliosis. The 40 participants in the study will be between the ages of 10 and 18, with Cobb angles ranging from 20 to 45 degrees.Consent forms will be obtained from all participants and parents participating in the study.

Semmes Weinstein Monofilament kit will be used to measure participants' sense of touch, Skinfold Caliper to measure subcutaneous fat tissue, Y-Balance Test for Dynamic Balance, and Scoliosis Research Society 22 (SRS-22) Evaluation Questionnaire. Measurements will be recorded before the birth of the corset and 12 weeks after the start of corset use. At the end of the 12th week, the brace will be evaluated for satisfaction with the Brace Questionnaire (BRQ).

Socio- demographic form information will be given at the first interview. In addition to the anamnesis, this form includes questions about whether the person exercises or not, whether there is a family member diagnosed with scoliosis, and the doctor's instructions for use of the orthosis.

Sense of Touch Assessment- Semmes Weinstein Monofilament Kit will be used in the study. This test is one of the tests commonly used to evaluate light touch sensation. Although it is mostly used in the palmar area, it is also used in certain parts of the body to test light touch sensation. Semmes-Weinstein Monofilament test is performed using filaments of different diameters with the same length. The thicknesses of the filaments are 2.83, 3.22, 3.61, 3.84 and 4.31. As the filament diameter thickens, the pressure given and the sensory input given increase accordingly. In the study, in individuals diagnosed with adolescent idiopathic scoliosis and with lumbar curvature, these filaments will be applied to two different regions of the curvature, concave and convex, at T10, L4 and L5, in order from thinnest to thickest. The number of the first monofilament felt will be recorded. Pressure will be applied until the 2.83 mm monofilament, which has the thinnest diameter, is curled, the person will be asked whether he/she feels the pressure, and if not, the application will continue by increasing the filament thickness accordingly.

Fat Tissue Measurement- Skinfold Caliper thickness measurement is performed to determine the fat tissue under the skin. A significant part of the fat in the body is collected under the skin. The thickness of the skinfold is evaluated with a special caliper called skinfold. Measurement is made by holding the skin and subcutaneous tissue with the thumb and index finger and pulling the natural skin piece away from the muscle. It is read in millimeters from the caliper indicator. Measurement of the evaluated area should be done twice, and if the difference is more than 2 mm, the measurement should be repeated. The body parts measured can be listed as triceps, biceps, subscapula, suprailiaca, front of the thigh, inner side of the calf, abdomen, chest and midaxilla. It is known that low body fat is a risk factor for the onset of scoliosis. In our study, fat tissue measurements will be made in the axilla, abdominal, suscapular and suprailiac regions.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
10 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Being diagnosed with Adolescent Idiopathic Scoliosis (AIS) between the ages of 10-18,
  • Curvature only in the lumbar region,
  • 20-45 degree curvature degree,
  • Being deemed suitable for spinal orthosis use by the doctor,
  • Not having used a spinal orthosis before

排除标准

  • Having different diagnoses such as congenital scoliosis, spina bfida, traumatic scoliosis, osteoporosis,
  • Having had spine surgery
  • Having used a scoliosis spinal orthosis,
  • Having an accompanying disease that may prevent the use of spinal orthosis and
  • Failure to sign the consent form required to participate in the study

结局指标

主要结局

The effect of spinal orthosis on the sense of touch

时间窗: 5 minute

Individuals between the ages of 10-18 included in the study will touch the ends of the monofilament kit, consisting of 6 different tips, to the concave and convex sections of the slope in the T10-L4 and L5 regions. The results are recorded when the individual answers "I felt it/I didn't feel it". Evaluations will be made immediately before orthosis use and 12 weeks after orthosis use.

次要结局

  • Effect of spinal orthosis on dynamic balance(10 minute)
  • Effect of spinal orthosis on fat tissue(5 minute)
  • The effect of spinal orthosis on quality of life(20 minute)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Başak İŞÇİOĞLU

Orthosist Prosthetist

Istanbul Medipol University Hospital

研究点 (1)

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