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临床试验/NCT06224361
NCT06224361已完成不适用

Reliability of a New Balance Assessment System in Patients With Adolescent Idiopathic Scoliosis

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年2月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Postural Stability Test

研究概览

简要总结

Postural stability is one of the most important factors determining a person's ability to initiate and maintain movement. In the presence of scoliosis, postural stability may be negatively affected due to somatosensory impairments. Numerous studies in the literature have evaluated postural stability in individuals diagnosed with scoliosis using objective methods.

The evaluation of postural sway with objective devices is used to determine whether postural stability changes in adolescent idiopathic scoliosis (AIS) and whether the type and location of scoliosis affect progression. The most commonly used objective devices for this purpose are balance assessment systems in which changes in postural sway are recorded on a force platform.

This study aims to investigate the reliability of the Postural Stability, Limits of Stability, Sensory Integration, and Bilateral Comparison tests of the Al Balance Balance Exercise and Analysis System in individuals with adolescent idiopathic scoliosis.

After the demographic information of participants who meet the inclusion criteria is recorded, postural stability and balance evaluations will be performed using the Al Balance System. Evaluations will be carried out with participants barefoot and with their feet positioned at the same coordinates.

Each test will last 30 seconds and will be repeated three times, with a 1-minute rest interval between trials. These measurements will be repeated after 7 days to evaluate reliability.

This study will test the reliability of a new, locally developed balance assessment system in individuals with adolescent idiopathic scoliosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Being between the ages of 12 and 18
  • Having been diagnosed with Adolescent Idiopathic Scoliosis by an orthopedic specialist
  • Cobb angle measured on anteroposterior radiograph is below 40 degrees
  • Ability to understand and follow instructions
  • Volunteering to participate in the study

排除标准

  • Presence of neuromuscular, rheumatic disease, or vestibular problems that may affect balance, vision-related diseases
  • Having a recent history of orthopedic injury or surgery in the lower extremity
  • Having had spine surgery
  • Not having experienced any acute situation that could affect postural stability and balance between the two tests (within 7 days)
  • Corset use has not changed between two tests (within 7 days)

结局指标

主要结局

Postural Stability Test

时间窗: Change from baseline to 7 day

Stability indices represent fluctuations around the zero point established before testing when the platform is stable. With the "Postural Stability Test", the anteroposterior, right-left, and general stability indexes of the cases will be recorded. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Postural Stability will be assessed with Postural Stability Test.

Limits of Stability

时间窗: Change from baseline to 7 day

In this test, the participant stands on force plates and deliberately shifts his or her body weight in the direction indicated on the screen without lifting his or her feet off the ground. This protocol measures various movement characteristics in 8 different directions: front, forward/right, right, back/right, back, back/left, left, and forward/left. During the test, participants will be asked to stand on the force platform with their feet in a comfortable position, arms at their sides, and palms facing toward the thighs. Direction control (%) and test times (sec) in all directions of the participants, who will move in 8 different directions sequentially, will be recorded. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Limits of Stability will be assessed with Limits of Stability Test.

Multimodal Functional Reach Test

时间窗: Change from baseline to 7 day

Multimodal functional reaching test is performed in three different positions: front, back, and side. In the functional forward reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken. In the functional back reach test, the patient stands with the arm flexed at 90° and the fist closed, not touching but close to the wall. Three attempts are made and the average of these attempts is taken. In the functional lateral reach test, the patient stands with his back to the wall, without touching the wall, keeping his arm in 90° abduction and his fist closed. Three attempts are made and the average of these attempts is taken. The participant's Multimodal Functional Reach balance will be assessed with Multimodal Functional Reach Test.

Sensory Integration Test

时间窗: Change from baseline to 7 day

The test decides which of the visual, vestibular, and proprioceptive information is used to provide orientation to maintain balance in different situations. During the test, visual and proprioceptive stimuli are disrupted and the ability to maintain the center of gravity is evaluated. The test consists of 4 different situations that gradually become more difficult: Situation 1: Eyes open; firm surface Situation 2: Eyes closed; firm surface Situation 3: Eyes open; foam surface Situation 4: Eyes closed; foam surface All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant will be asked to stand still looking at the screen in front of him for 30 seconds. There will be a 1-minute rest break between measurements and they will be performed 3 times. The participant's Sensory Integration will be assessed with Sensory Integration Test.

Bilateral Comparison Test

时间窗: Change from baseline to 7 day

Bilateral Comparison test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. On the balance platform, the individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. All measurements will be made with bare feet, and without shoes, and foot position will be recorded using coordinates on the platform's grid to ensure consistency in testing. The participant's Bilateral Comparison will be assessed with Bilateral Comparison Test.

One Leg Stance Test

时间窗: Change from baseline to 7 day

The one-leg stance test demonstrates postural stability by measuring the individual's ability to stand on one leg with eyes open and closed. The individual stands on one leg with his hands at hip level. The test is repeated for the right foot and left foot. For both feet, 3 trials with eyes open and 3 trials with eyes closed are made. Each trial lasts 30 seconds. What is required from the individual is to remain stable on one leg as much as possible without losing balance. The participant's One Leg Stance balance will be assessed with One Leg Stance Test.

次要结局

未报告次要终点

研究者

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

Elcin Akyurek

Principal Investigator

Istanbul University - Cerrahpasa

研究点 (1)

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