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临床试验/NCT04600102
NCT04600102撤回不适用

SCANLOAD: The Effect of Limb Loading on Lower Limb Geometry

University of Iowa1 个研究点 分布在 1 个国家开始时间: 2020年10月27日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Width of the metatarsal heads

研究概览

简要总结

Orthotists currently use a range of weight bearing conditions when casting or scanning a patient's limb during the Ankle foot orthosis (AFO) fitting process. This variability in clinical practice is the result of differing opinions regarding the best method for fitting, and a limited understanding of how weight bearing affects the resulting geometry. Few studies have been performed to determine the effect of weight bearing on resulting geometry, or the consistency of the geometry obtained. In this study we seek to evaluate the effect of foot loading on lower limb geometry and the consistency of measurements using low-cost 3D scanning technology, with implications for fitting AFOs.

详细描述

Two groups of subjects will be recruited for this study. The first group (Group 1) will consist of healthy, able-bodied individuals with no history of lower extremity trauma. The second group (Group 2) will consist of individuals with unilateral, below-knee functional deficits that require an AFO for daily activities (e.g. fracture, muscle and/or nerve injury, ankle arthritis, or peripheral neurologic disease).

We will obtain a brief medical history to identify major medical conditions or prior injuries that could influence limb geometry and lead to reliance on an AFO for Group 2 participants.

A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.), which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the scanner, the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed. Measurements will be evaluated using digital imaging analysis software (Standard Cyborg, Inc.). The different conditions being tested are full weight bearing, partial weight bearing, and non-weight bearing. The effect of limb loading on multiple measures of limb geometry will be evaluated. Limb measurements will include 1) width of the metatarsal heads, 2) width of the calcaneus, 3) foot length, 4) foot height, 5) arch height, 6) medial-lateral width between ankle malleoli, 7) minimum circumference above the ankle malleoli, 8) maximum calf circumference , 9) medial-lateral width of the knee condyles 10) anterior-posterior width at mid patellar tendon, 11) distance from bottom of foot to tibial tubercle.

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
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Width of the metatarsal heads

时间窗: Less than 2 days

Distance from the medial aspect of the first metatarsal head to the lateral aspect of the fifth metatarsal head.

Foot height

时间窗: Less than 2 days

Distance from the most superior point on the foot distal to the tibialis anterior insertion.

Arch height

时间窗: Less than 2 days

Dorsum height at 50% foot length.

Medial-lateral ankle malleoli width

时间窗: Less than 2 days

Distance from the lateral malleolus to the medial malleolus.

Minimum ankle circumference

时间窗: Less than 2 days

Minimum ankle circumference above the ankle malleoli. Must be less than 10 cm proximal to the ankle malleoli.

Width of the calcaneus

时间窗: Less than 2 days

Distance from the medial aspect of calcaneus parallel to lateral aspect of calcaneus.

Foot length

时间窗: Less than 2 days

Distance from the most posterior aspect of calcaneus to the most anterior toe (1st or 2nd).

Maximum calf circumference

时间窗: Less than 2 days

Maximum calf circumference greater that 5 cm distal to the knee condyles.

Width of the knee condyles

时间窗: Less than 2 days

Distance from the medial condyle to the lateral condyle.

Anterior-posterior width at patella

时间窗: Less than 2 days

Distance from mid patellar tendon to a parallel point most posterior on the back of the knee.

Tibial tubercle height

时间窗: Less than 2 days

Distance from the floor to tibial tubercle.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jason Wilken

Principal Investigator

University of Iowa

研究点 (1)

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