Comparing Intact and Residual Amputated Neuromuscular Physiology
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 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
- 是
入选标准
- •for Individuals without Amputation:
- •Live in the United States
- •Are 18 years of age or older
- •Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty
排除标准
- •for Individuals without Amputation:
- •- Have any cognitive, visual, or balance impairments that affects your ability to provide informed consent or to follow instructions during the experiments
- •Have had a stroke
- •Have heart disease
- •Weigh 450 pounds or more (for harness safety)
- •Have a girth/waist circumference more than 49 inches (124.4 cm) (for harness safety)
- •Have allergies to adhesives
- •Inclusion Criteria for Individuals with Amputation:
- •Live in the United States
- •Are a unilateral lower-limb amputee
- •Have lower limb length from the knee to where the amputation occurred at least 10cm long
- •Can walk across low-level environmental barriers such as curbs, stairs, or uneven surfaces unassisted and without much difficulty
- •Exclusion Criteria for Individuals with Amputation:
- •- Have any cognitive, visual, or balance impairments that affects your ability to provide consent or to follow instructions during the experiments
- •Have had a stroke
- •Have heart disease
- •Had skin lesions/incomplete healing following amputation
- •Have ulcers
- •Have lower limb length from the knee to where the amputation occurred less than 10cm long
- •Weigh 450 pounds or more (for harness safety)
- •Have a girth/waist circumference more than 49 inches (124.4 cm) (for harness safety)
- •Have allergies to adhesives
研究组 & 干预措施
Individuals Without Amputation
No Intervention Tested in identical tasks for comparison to Individuals with Amputation
Individuals With Amputation
Tasks with a passive prosthesis Tasks with a powered active prosthesis
干预措施: Powered Prosthesis (Device)
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
He Huang
Jackson Family Distinguished Professor
North Carolina State University