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临床试验/NCT03498872
NCT03498872已完成不适用

Exercise and the Brain in Health & Disease: The Added Value of Human-Centered Robotics

Vrije Universiteit Brussel2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2016年10月1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
18
试验地点
2
主要终点
EEG extracted brain signals, i.e. motor-related cortical potentials

研究概览

简要总结

Objectives: The main objectives are to determine neural dynamics during gait using electro-encephalography as well as brain sources and to investigate the attentional demand during walking in able-bodied individuals, and individuals with an amputation.

Materials & Methods: 6 able-bodied individuals conducted one experimental trial, and 6 unilateral transtibial and 6 unilateral transfemoral amputees performed 2 experimental trials; the first with the current and the second with a novel powered transtibial prosthesis, i.e. the Ankle Mimicking Prosthetic foot 4.0. Each experimental trial comprised 2 walking tasks; 6 and 2min treadmill walking at normal speed interspersed by 5min of rest. During 6min walking the sustained attention to response (go-no go) task, with measures reaction time and accuracy, was performed. Electro-encephalographic (EEG) data were gathered when subjects walked 2min. Motor-related cortical potentials and brain activity during gait are extracted using EEG.

详细描述

Detailed description of the novel device:

The device mainly distinguishes itself from commercial prostheses thanks to its new type of actuation providing a compact and energy efficient solution to the challenge of ankle-foot actuation. This new actuation method consists of using springs, a servo motor and a locking mechanism, coupled with a sensory network providing intelligence to the robotic device. The AMPfoot 4.0 design is also based on previous research conducted on the AMP-Foot 2. However, it is important to note that in contrast with its preceding designs, the AMP-Foot 4.0 does not provide active propulsion at push-off.

During walking, the AMP-Foot 4.0 working principle is divided into two main logic sequences, i.e. the stance and the swing phase. These two phases are detected by analyzing gyroscope and acceleration measurements from an Inertial Measurement Unit chip. During the stance phase, the ankle performs a dorsi-flexing movement while a plantar-flexing torque is applied at the ankle. The person's gravitational potential energy is stored into elastic potential energy by means of the used spring. It is this spring that provides the plantar-flexing torque required at the ankle as reaction to the movement of the user. Due to the use of a locking system, the prosthesis can adapt its so-called zero torque rest point depending on the slope or stride length of the user. This provides adaptability and therefore greater comfort compared to prostheses with a fixed zero torque rest point. During the swing phase, the locking mechanism unlocks to free the ankle movement. Parallel springs external to the stance system are then activated to reset the foot to its initial position. From that moment, the device is ready for a new step.

研究设计

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

入排标准

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

入选标准

  • Unilateral transfemoral amputees
  • Unilateral transtibial amputees
  • Able-bodied individuals

排除标准

  • Functional k-level lower than 4 (Amputee has the ability for prosthetic ambulation that exceeds basic ambulation skills, exhibiting high impact, stress or energy levels)

研究组 & 干预措施

Transtibial amputee

Experimental

干预措施: AMPfoot 4.0 (Device)

Transfemoral amputee

Experimental

干预措施: AMPfoot 4.0 (Device)

Able-bodied individuals

Active Comparator

干预措施: No intervention (Other)

结局指标

主要结局

EEG extracted brain signals, i.e. motor-related cortical potentials

时间窗: Through study completion, a period of 2 months

Non-invasive electro-encephalography was used to determine electro-cortical potentials and brain sources of these potentials

Reaction time (in ms) of responses during go - no go cognitive task

时间窗: Through study completion, a period of 2 months

Time between visual stimulus and motor response (pushing button)

Accuracy (in percentage) of correct responses during go - no go cognitive task

时间窗: Through study completion, a period of 2 months

Accuracy of motor responses to visual stimuli

次要结局

未报告次要终点

研究者

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

Romain Meeusen

Prof. Dr.

Vrije Universiteit Brussel

研究点 (2)

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