The Effect of Different Hyperextension Braces on Spinal Mobility
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Spinal Mobility (Range of Motion)
研究概览
简要总结
This project aims to investigate the effects of different hyperextension braces (Jewett and Spinomed) on spinal mobility and posture. Hyperextension braces are commonly prescribed to limit spinal flexion and regulate load distribution, especially in cases of spinal injuries and postural disorders. However, their objective impact on spinal biomechanics remains unclear.
Purpose and Scope The study will be conducted on 30 healthy participants aged 18-35.
Spinal mobility, posture, and movement analysis will be assessed using a dual inclinometer and the PostureScreen mobile application.
Evaluations will be performed under three conditions:
- Without a brace
- With a Jewett brace
- With a Spinomed brace (applied in randomized order)
Assessments will include four-direction spinal mobility and postural analysis during daily life activities such as standing, squatting, and single-leg stance.
Hypotheses H0: Hyperextension braces do not restrict spinal mobility. H1: Hyperextension braces restrict spinal mobility. H2: Hyperextension braces do not alter body alignment during movements. H3: Hyperextension braces alter body alignment during movements.
Methodology
The study is designed as a cross-sectional trial.
Each measurement will be repeated three times. Data will be analyzed statistically using ANOVA or Kruskal-Wallis tests depending on distribution.
Ethical approval has been obtained (Yalova University, Protocol No: 2024/4).
Expected Contributions Academic: Results are expected to be presented at the Congress of the International Society of Biomechanics (2025) and published in a high-impact Q1 journal such as Spine.
Clinical: Findings will provide objective data on the effectiveness of hyperextension braces, guiding clinicians and physiotherapists in brace selection.
Educational: The project will also contribute to the training of young researchers, offering hands-on experience in research design and execution
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy young adults aged 18-
- •Body mass index (BMI) between 18.5 and 24.9 kg/m2
排除标准
- •Having experienced pain, discomfort, or discomfort in the upper back, waist, or lower extremities in the last 4 weeks on the Nordic Musculoskeletal System Questionnaire.
- •A score above 20 on the Oswestry Disability Questionnaire.
- •Having a condition related to spinal malalignment identified by a specialist physician (such as scoliosis, hyperkyphosis, hypokyphosis, Schuerman's kyphosis).
- •Having a history of congenital hip dislocation.
- •Having had surgery on the lower extremities or spine.
- •Having a neurological disease or medication use that could cause balance loss.
- •Having engaged in regular exercise in the last 6 months.
- •Having a history of regular brace use in the last 6 months.
- •Having a rheumatic disease affecting the axial skeleton.
- •Having a diagnosis of a disease related to the axial skeleton, such as spondylosis, spondylolisthesis, spinal stenosis, or disc herniation.
研究组 & 干预措施
Spinomed
In this study, the effects of the Spinomed brace on spinal mobility will be evaluated. Participants will be fitted with the Spinomed brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Spinomed brace on spinal mobility and to contribute to evidence-based clinical practice.
干预措施: Spinal hyperextension brace (Other)
Jewett
In this study, the effects of the Jewett brace on spinal mobility will be evaluated. Participants will be fitted with the Jewett brace for a defined period, and spinal range of motion will subsequently be assessed. Measurements will be performed using the dual inclinometer method, which provides an objective and reliable evaluation of spinal movements, including flexion, extension, lateral flexion, and rotation. The data obtained will be analyzed to determine the impact of the Jewett brace on spinal mobility and to contribute to evidence-based clinical practice.
干预措施: Spinal hyperextension brace (Other)
结局指标
主要结局
Spinal Mobility (Range of Motion)
时间窗: 11 months
Sppinal ROM in flexion, extension, and lateral flexions will be measured using dual inclinometers to assess the impact of each brace.
Spinal Mobility (Range of Motion)
时间窗: 11 months
Sppinal ROM in flexion, extension, and lateral flexions will be measured using dual inclinometers to assess the impact of each brace.
次要结局
- Postural Alignment Scores via PostureScreen App(11 months)
- Postural Alignment Scores via PostureScreen App(11 months)
研究者
Mustafa Tahsin Ozer
Research assisstant
Izmir University of Economics