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临床试验/NCT06127264
NCT06127264招募中不适用

Reliability of Force Measurement Within the Carbon Fiber Orthosis Proximal Cuff

University of Iowa2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
Proximal Cuff Force

研究概览

简要总结

The primary purpose of this research study is to determine if forces within carbon fiber custom dynamic orthoses (CDOs) can be reliability assessed using Loadpad and Loadsol force measuring sensors (Novel GMBH, St. Paul, MN). An improved understanding of the forces acting within orthoses may help to guide future orthosis related research studies, provision methods, and patient education.

Study participants will consist of three groups; 1) healthy, able-bodied adult participants using generic sized CDOs, which consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy, and a semi-rigid footplate that acts as a lever arm to bend the posterior strut, 2) individuals without peripheral neuropathy who use AFO(s) regularly, and 3) individuals with peripheral neuropathy who use AFO(s) regularly. .

Group 1 participants will be asked to fasten the proximal cuff to a self-selected cuff tightness 'SSCT', as well as three different predefined force levels; 'Loose' where the proximal cuff is loosely fastened around the participants leg, 'Moderate' where the proximal cuff is fastened with moderate tightness, and 'Tight' where the proximal cuff is tightly fastened around the participants leg. Testing in the predetermined force levels (Loose, Moderate, Tight) will occur in a randomized order. Group 2 and Group 3 participants will be asked to fasten their AFO(s) to a self-selected 'SSCT' tightness.

For all groups, forces acting on the leg, within the proximal cuff, will be measured using wireless Loadpad sensors and forces acting on the foot will be measured using wireless Loadsol insoles. Testing will include collection of force data as participants sit quietly, stand quietly, and walk and completion of questionnaires.

详细描述

Ankle foot orthoses (AFOs) are medical devices often used to support the foot and ankle during daily activities. Carbon fiber custom dynamic orthoses (CDOs), one subset of AFOs, that consist of a proximal cuff that wraps around the leg just below the knee, a posterior carbon fiber strut that runs the length of the leg and bends to store and return energy during gait, a semi-rigid carbon fiber footplate that acts as a lever arm to bend the posterior strut, and in some cases a foam heel wedge placed between the footplate and the shoe. Different CDO design characteristics, such as posterior strut stiffness, device alignment, and heel cushion height and stiffness have been studied in the past. While different design characteristics have been studied previously, there is little information available concerning the proximal cuff and how it impacts patient outcomes. Different types of AFOs and CDOs have been used in an effort to offload the limb for years. Both CDOs and patellar tendon bearing (PTB) style AFOs have been shown to reduce forces acting on the plantar surface of the foot. While multiple studies have indicated the importance of fastening the proximal cuff, few have actually investigated the forces acting within the proximal cuff. A loose proximal cuff has been associated with pistoning of the limb, where the limb translates down within the proximal cuff during loading, potentially increasing forces acting on the foot and reducing the offloading effects of the orthosis. Only one study investigated the effects of altering forces within the proximal cuff by adding more padding to the proximal cuff, which was shown to improve limb offloading.

A better understanding of the forces acting within the proximal cuff, and how these effect patient outcomes would help to guide future AFO related research studies, provision, and patient education. At this point in time there is little guidance available to inform patients how tightly they need to secure the proximal cuff when wearing an AFO, many clinicians recommend tightening it so that it's secure, but not uncomfortable. The ability to measure forces within the proximal cuff and an idea of the range of forces seen in a clinical setting will act as a first step to better understanding how forces acting within the proximal cuff impact patient outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

盲法说明

Participants will be blinded, to the greatest extent possible, to the different CDO proximal cuff tightness's.

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Between the ages of 18 and 90
  • Use an AFO(s) for daily activities
  • The AFO(s) proximal cuff is compatible with loadpad sensors
  • Have used their AFO(s) for a minimum of 2 weeks
  • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
  • Ability to read and write in English and provide written informed consent
  • Exclusion Criteria
  • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
  • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
  • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • BMI > 40
  • Pregnancy
  • Group 3 - AFO Users with Peripheral Neuropathy
  • Inclusion Criteria:
  • Between the ages of 18 and 90
  • Use an AFO(s) for daily activities
  • The AFO(s) proximal cuff is compatible with loadpad sensors
  • Have used their AFO(s) for a minimum of 2 weeks
  • Ability to walk 50 feet without use of an assistive device (e.g. cane, crutch, etc.)
  • Diagnosis or indication of peripheral neuropathy determined using Semmes Weinstein Filaments
  • Ability to read and write in English and provide written informed consent
  • Exclusion Criteria
  • Medical or psychological condition that would preclude functional testing (ex. Moderate or severe brain injury, stroke, heart disease)
  • Requirement of a knee stabilizing device (e.g. KAFO, KO) to preform daily activities
  • Visual or hearing impairments that limit walking ability or limit the ability to comply with instructions given during testing
  • BMI > 40
  • Pregnancy

排除标准

  • 未提供

结局指标

主要结局

Proximal Cuff Force

时间窗: Baseline

Proximal cuff forces (N) will be measured as participants sit, stand, and walk without a CDO and in each CDO condition.

Peak Plantar Force

时间窗: Baseline

Plantar forces (N) will be measured across the total foot, the hindfoot, midfoot, and forefoot as participants sit, stand, and walk without a CDO and in each CDO condition.

Plantar Force Impulse

时间窗: Baseline

Plantar force impulse (Ns) across the total foot, the hindfoot, midfoot, and forefoot will be calculated using the integral of the force over the stance phase as participants sit, stand, and walk without a CDO and in each CDO condition.

Numerical Pain Rating Scale

时间窗: Baseline

Pain will be assessed using a standard 11-point numerical pain rating scale, in which 0 = no pain and 10 = worst pain imaginable

Modified Socket Comfort Score (Comfort)

时间窗: Baseline

Comfort scores range from 0 = most uncomfortable to 10 = most comfortable

次要结局

  • Modified Socket Comfort Score (Smoothness)(Baseline)

研究者

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

Jason Wilken

Associate Professor

University of Iowa

研究点 (2)

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