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临床试验/NCT01749657
NCT01749657Unknown不适用

Kinematic and Kinetic Effects of Orthotic Devices for Subjects With Stage II Posterior Tibial Tendon Dysfunction

State University of New York - Upstate Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Foot Function Index - Revised

研究概览

简要总结

The lack of high quality evidence to guide conservative care for patients with posterior tibial tendon dysfunction (PTTD) has led to controversy over clinical care. Numerous orthotic devices are available to avoid a costly and debilitating surgery but no consensus on which to use has been made. The current study aims to link biomechanical testing of selected devices to clinical outcomes in subjects with PTTD after wearing a device for 12 weeks.

详细描述

Orthotic devices serve as essential elements of conservative care programs for posterior tibial tendon dysfunction (PTTD). Data on currently used devices remain limited. Current device designs are restrictive and focus on correction of flatfoot kinematics in subjects with stage II PTTD. Restrictive designs that limit ankle motion may lead to weakness and altered gait dynamics. It remains unclear if less restrictive device designs would be more optimal for subjects with stage II PTTD. The aims of the current proposal are to examine the in-vivo biomechanics of different device designs and to use outcomes to identify the device and design optimal for subjects with stage II PTTD. Research Design: This study will use a laboratory based repeated measures design to explore the function of four different orthotic devices in a sample of 60 subjects with stage II PTTD at baseline. Then each subject will be followed prospectively for 12 weeks while wearing one of the orthotic devices. Clinical outcomes including strength, tendon morphology, and self-reported outcomes will be measured at 12 weeks. Baseline foot kinematics will be collected using a three segment foot model (first metatarsal, calcaneus, tibia) while data on ankle kinetics will be derived from the kinematic data and the ground reaction forces. Impact: There are currently no head-to-head comparisons available among the various devices used in the conservative management of stage II PTTD. The proposed study will provide the necessary controlled data to determine the kinematic and kinetic effects of selected devices and the specific components needed to optimize device design. Outcomes will be used to determine which designs are successful to use clinically.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Inclusion Criteria Stage II PTTD
  • •Pain with Palpation along the tendon
  • •Rearfoot eversion
  • •Pain single leg heel raise
  • •Flexible flat foot deformity
  • •Able to walk 15 m
  • •> 40 years of age

排除标准

  • •Unable to walk 15 m
  • •Symmes-Weinstein monofilament test 5.06 mm
  • •Inflammatory arthropathies (e.g. rheumatoid arthritis, psoriasis)
  • •Co-morbid foot conditions (e.g. hallux rigidis, plantar fasciitis)
  • •Inability to assume a STN posture

研究组 & 干预措施

Off-the-shelf Device and shoe

Active Comparator

subjects will wear an off-the-shelf orthotic device (AirLift PTTD Brace) and standard Edge shoe (Aetrex Co) for 12 weeks

干预措施: Arizona (Device)

Custom Device - standard and Shoe

Experimental

subjects will wear a custom (standard) orthotic device (Arizona Co) and Edge shoes (Aetrex Co.) for 12 weeks.

干预措施: Arizona (Device)

Custom Articulated device and Shoe

Experimental

subjects will wear a custom articulated device (Arizona Co) and Edge shoe (Aetrex Co)for 12 weeks

干预措施: Arizona (Device)

Custom Extended Device and Shoe

Experimental

subjects will wear a custom extended foot plate orthotic device (Arizona Co) and Edge shoe (Aetrex Co) for 12 weeks.

干预措施: Arizona (Device)

结局指标

主要结局

Foot Function Index - Revised

时间窗: 12 weeks

The Foot Function Index - Revised (FFI-R) is a newly published version of the original Foot Function Index (FFI) \[45\]. The original FFI is a validated, disease specific questionnaire that is widely used to measure foot function and document outcomes in observational studies of PTTD \[31, 33\]. Rasch analyses for the FFI-R indicated a Pearson reliability of 0.96 and item reliability of 0.93. The domains of the 34 items in the FFI-R questionnaire include pain and stiffness, social/emotional issues, personal disability, and social activity limitation. Although the FFI-R is relatively new, the 23 items from the FFI were the basis for the revised scale. The FFI has been used to measure outcomes for a variety of foot and ankle problems including plantar fasciitis, diabetes, and PTTD \[32\]. The overall score of the FFI-R will be used as a primary outcome variable while the subscales will be used as secondary outcome variables.

次要结局

  • Foot and Ankle Ability Measure(12 weeks)
  • Ankle Strength(12 weeks)
  • Hip Strength(12 weeks)
  • Deep Posterior Compartment Strength(12 weeks)

研究者

发起方
State University of New York - Upstate Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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