Validation of Plantar Orthoses for Abnormal Plantar Arch Using a New Non-invasive Clinical Imaging System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months
研究概览
简要总结
The goal of this project is to validate a new non-invasive clinical imaging system to evaluate the efficacy of plantar orthotics and to assess the biomechanical efficiency of plantar orthotics for people with flat or high arch feet. The Cryovizion system should detect changes in participants' posture with an accuracy of 95%, while orthotics should improve the body's postural symmetry index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No musculoskeletal disorders
- •No balance disorders
- •No pathologies linked to the central nervous system
- •No use of drugs affecting the balance
排除标准
- •People with foot pathology other than the arch;
- •People with diabetes ;
- •People with severe obesity ;
- •People wearing high heel shoes regularly ;
- •People with degenerative disease ;
- •People with neuromuscular pathology ;
- •People with a circulatory disorder ;
- •People who have had major lower body surgery;
- •Inability to walk 30 minutes continuously.
结局指标
主要结局
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 2 Months
时间窗: Baseline and 2 months
Change in body's postural symmetry index(SSIM gray) at 2 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 12 Months
时间窗: Baseline and 12 months
Change in body's postural symmetry index(SSIM gray) at 12 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Body's Postural Symmetry Index(SSIM Gray) at 6 Months
时间窗: Baseline and 6 months
Change in body's postural symmetry index(SSIM gray) at 6 months after the beginning of the intervention. This index is calculated from the full body image based on the Cryovision topographic color imaging system. Index values can range from -1 to 1. 0 indicates no symmetry, 1 indicates perfect symmetry and -1 indicates perfect anti-symmetry.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 2 Months
时间窗: Change between directly after 2 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 2 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 6 Months
时间窗: Change between directly after 6 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 6 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
Change From Baseline in Asymmetry of Flexion/Extension Angle of Lower Body Joints During Gait Without Foot Orthotics at 12 Months
时间窗: Change between directly after 12 months of intervention and baseline values
Change from baseline in absolute asymmetry values of flexion/extension angle of lower body joints during gait at 12 months. The reported values are means of the absolute value of left side flexion/extension joint angle minus right side flexion/extension joint angle. Value=abs(Left joint angle - Right joint angle ). Joint angle values were calculated according to International Society of Biomechanics (ISB) recommandations. Values are reported for hip, knee and ankle asymmetry for gait with shoes but without foot orthotics.
次要结局
未报告次要终点