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临床试验/NCT07159490
NCT07159490已完成不适用

Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads

VA Puget Sound Health Care System1 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2020年12月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
13
试验地点
1
主要终点
Vertical Ground Reaction Force Impulse (Normalized)

研究概览

简要总结

The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.

详细描述

The natural lower limbs provide important biomechanical functions such as body weight support, forward propulsion, and balance control during ambulation. When the loads borne by the lower limbs change, lower limb muscle activation responds accordingly to enable seamless continuation of biomechanical function. These loads can change suddenly, such as when carrying an infant, toddler, or other load like a heavy backpack. For individuals with a lower limb amputation, these sudden changes to weight-bearing loads can be problematic because they can negatively impact walking performance. One reason walking performance may suffer is that the properties of most prosthetic limbs, such as their stiffness, are constant and do not change to suit varying load conditions. Another reason is that the most widely prescribed prosthetic feet do not have motors, sensors, or brain-like controllers that act to replace the neuromuscular system of the amputated limb. Regardless of the reason, no evidence exists to guide prescription practice for veterans who walk with a prosthesis and experience sudden load changes.

The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads. The investigators will conduct a human subject experiment with help of twenty individuals with below-knee amputations. Study participants will walk on a treadmill with no added load and four added load conditions using a weighted pack (13.6 kg or ~30 lbs) to simulate an infant, toddler, or other load. The four conditions include the pack strapped to their front, their back, and carried with their arms on the intact limb side and the prosthetic limb side. Each participant will wear a usual prosthetic foot, this same foot with a heel-stiffening wedge, the same prosthetic foot but one category stiffness higher, a new-to-market dual keel prosthetic foot intended for load carrying situations, and a powered ankle foot prosthesis. The results from these experiments will aid clinicians in specifying the best prosthesis for individuals with lower limb amputations who frequently carry infants, toddlers, or other loads.

For individuals who wear a lower limb prosthesis while carrying infants, toddlers, or other loads, this research will provide evidence to support prosthesis prescription practice that reduces undesirable compensatory responses to load carriage. The objective is to help clinicians select among currently available solutions to enable individuals with lower limb loss to achieve their life and work goals.

研究设计

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

盲法说明

A sock and foot cover to blind the participants to the study prostheses when possible (use of the powered ankle-foot will be obvious).

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Unilateral transtibial amputee
  • •Have been fitted with and used a prosthesis for at least six months
  • •Do not use heel stiffening wedges or bumpers in their as-prescribed prosthesis
  • •Wear their prosthesis for at least four hours per day
  • •Are moderately active by self-report
  • •Can be fitted with the study prostheses (prosthetic foot size, stiffness category and build heights)

排除标准

  • •Do not have a proper fit and suspension and one cannot be achieved with clinical resources
  • •Presence of disorder, pain, or injury other than amputation that interferes with gait

研究组 & 干预措施

Prosthetic-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

干预措施: Standard-of-care prosthetic foot (Device)

No added load

Experimental

Study participants will walk with no added load.

干预措施: Powered ankle-foot (Device)

No added load

Experimental

Study participants will walk with no added load.

干预措施: Standard-of-care prosthetic foot (Device)

No added load

Experimental

Study participants will walk with no added load.

干预措施: Standard-of-care prosthetic foot with heel-stiffening wedge (Device)

No added load

Experimental

Study participants will walk with no added load.

干预措施: Standard-of-care prosthetic foot of one category greater stiffness (Device)

No added load

Experimental

Study participants will walk with no added load.

干预措施: Dual keel prosthetic foot (Device)

Anterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

干预措施: Standard-of-care prosthetic foot (Device)

Anterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

干预措施: Standard-of-care prosthetic foot with heel-stiffening wedge (Device)

Anterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

干预措施: Standard-of-care prosthetic foot of one category greater stiffness (Device)

Prosthetic-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

干预措施: Standard-of-care prosthetic foot with heel-stiffening wedge (Device)

Anterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

干预措施: Dual keel prosthetic foot (Device)

Anterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

干预措施: Powered ankle-foot (Device)

Posterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

干预措施: Standard-of-care prosthetic foot (Device)

Posterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

干预措施: Standard-of-care prosthetic foot with heel-stiffening wedge (Device)

Posterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

干预措施: Standard-of-care prosthetic foot of one category greater stiffness (Device)

Posterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

干预措施: Dual keel prosthetic foot (Device)

Posterior added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

干预措施: Powered ankle-foot (Device)

Intact-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

干预措施: Standard-of-care prosthetic foot (Device)

Intact-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

干预措施: Standard-of-care prosthetic foot with heel-stiffening wedge (Device)

Intact-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

干预措施: Standard-of-care prosthetic foot of one category greater stiffness (Device)

Intact-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

干预措施: Dual keel prosthetic foot (Device)

Intact-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

干预措施: Powered ankle-foot (Device)

Prosthetic-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

干预措施: Standard-of-care prosthetic foot of one category greater stiffness (Device)

Prosthetic-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

干预措施: Dual keel prosthetic foot (Device)

Prosthetic-side added load

Experimental

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

干预措施: Powered ankle-foot (Device)

结局指标

主要结局

Vertical Ground Reaction Force Impulse (Normalized)

时间窗: During study visit (approximately 3 hours)

A measure of body support. Normalized by body mass, including the mass of the load when applicable.

Anterior Ground Reaction Force Impulse (Normalized)

时间窗: During study visit (approximately 3 hours)

A measure of body forward propulsion. Normalized by body mass, including the mass of the load when applicable.

Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)

时间窗: During study visit (approximately 3 hours)

A measure of balance control primarily for anterior and posterior added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.

Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)

时间窗: During study visit (approximately 3 hours)

A measure of balance control primarily for intact-side added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.

Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)

时间窗: During study visit (approximately 3 hours)

Positive ankle joint mechanical work over the prosthetic limb gait cycle is a measure of propulsion capability. A prosthetic foot with greater propulsion capability may enhance gait efficiency during everyday ambulation. Normalized to body mass and the added load mass when applicable.

次要结局

未报告次要终点

研究者

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

Glenn K. Klute, PhD

Research Career Scientist / Affiliate Professor

VA Puget Sound Health Care System

研究点 (1)

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