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临床试验/NCT06182202
NCT06182202招募中不适用

Comparing Intact and Residual Amputated Neuromuscular Physiology

North Carolina State University2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2022年6月17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
80
试验地点
2
主要终点
Motor Unit Action Potential Amplitudes

研究概览

简要总结

Lower limb amputees rely on their prosthetic to remain active and lead an independent life. In recent years, measuring residual muscle activity has been used to interpret a user's intent and thereby modulate prosthesis control. However, little knowledge is held on how residual muscle activity differs from non-amputated muscle. The research team will analyze and compare neuromuscular physiology in non-amputee individuals and amputees' non-amputated and residual muscles across functional tasks to better understand how amputees control their muscles. Such information will inform design of modern prosthesis controllers.

详细描述

There will be approximately 80 participants in this study: 40 who have lower-limb amputations and 40 who do not.

A minimum of 48 hours will separate each testing session.

A warm-up is incorporated into every session and subjects will regularly take breaks between trials. The research team will check in with them regularly, and they are welcome to tell us when they want a break or stop at any time for any reason.

Subjects will be asked to conducted controlled isolated muscle activity of their ankle muscles, given feedback of their muscle activation to control their effort and prevent fatigue. Following activity of isolated muscles, subjects will be asked to conduct functional tasks including quiet standing, postural sways, sitting down and standing up, squats, heel-raises, and walking.

Individuals with amputation will conduct the tasks with their personal passive prosthesis device as well as a powered active prosthesis (following socket fitting and appropriate adjustment to comfort by a certified, trained prosthetist) to compare muscle activity in functional tasks. Individuals without amputation will conduct the tasks for further comparison.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 64 Years(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

Motor Unit Action Potential Amplitudes

时间窗: Through study completion (an average of 36 months).

The investigators will measure muscle activity via electromyography on the individuals' muscles controlling their ankle joint (note for residual muscle they are controlling their phantom limb). Properties of motor units will be gathered from surface electromyography (EMG) decomposed into individual motor unit firings. These properties will be compared between intact and residual muscle.

Motor Unit Coherence

时间窗: Through study completion (an average of 36 months).

The investigators will measure muscle activity via electromyography on the individuals' muscles controlling their ankle joint (note for residual muscle they are controlling their phantom limb). Properties of motor units will be gathered from surface electromyography (EMG) decomposed into individual motor unit firings. These properties will be compared between intact and residual muscle.

次要结局

  • Muscle Architecture Properties -- Muscle Volume(Through study completion (an average of 36 months).)

研究者

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

He Huang

Jackson Family Distinguished Professor

North Carolina State University

研究点 (2)

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