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临床试验/NCT05249595
NCT05249595Unknown不适用

Ultrasound Imaging Based Sensing to Predict Human Ankle Movement Intent and Assist-As-Needed Control Using Functional Electrical Stimulation and Powered Ankle Exoskeleton

North Carolina State University4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年2月10日最近更新:
适应症

试验速览

阶段
不适用
入组人数
25
试验地点
4
主要终点
Evaluate the controller performance of human ankle joint

研究概览

简要总结

Robotic therapies aim to improve limb function in individuals with neurological injury. Modulation of robotic assistance in many of these therapies is achieved by measuring the extant volitional strength of limb muscles. However, current sensing techniques, such as electromyography, are often unable to correctly measure the voluntary strength of a targeted muscle. The difficulty is due to their inability to remove ambiguity caused by interference from activities of neighboring muscles. These discrepancies in the measurement can cause the robot to provide inadequate assistance or over-assistance. Improper robotic assistance slows function recovery, and can potentially lead to falls during robot-assisted walking. An ultrasound imaging approach is an alternative voluntary strength detection methodology, which can allow direct visualization and measurement of muscle contraction activities. The aim is to formulate an electromyography-ultrasound imaging-based technique to sense residual voluntary strength in ankle muscles for individuals with neuromuscular disorders. The estimated voluntary strength will be involved in the advanced controller's design of robotic rehabilitative devices, including powered ankle exoskeleton and functional electrical stimulation system.

It is hypothesized that the ankle joint voluntary strength will be estimated more accurately by using the proposed electromyography-ultrasound imaging-based technique. And this will help the robotic rehabilitative devices achieve a more adaptive and efficient assistance control, and maximize the ankle joint rehabilitation training benefits.

详细描述

The study will recruit up to 20 persons without any neuromuscular diseases and 5 persons with incomplete spinal cord injury (iSCI) or transverse myelitis, who are 18-64 years old for experiments. Research activities include an average of 8 experimental sessions. The sessions can be more or less than 8 sessions depending on subject availability, sufficient data for analysis, or need to obtain more data for the analysis. The first aim is to investigate ultrasound measurements of muscle movements and muscle electrical activity (sEMG) to predict the voluntary motion or torque produced at the human ankle joint. Based on the voluntary motion or torque, functional electrical stimulation (FES) will be used to artificially stimulate the ankle muscles or a powered ankle exoskeleton will be used to provide additional assistance at the ankle joint. FES electrodes will be placed at appropriate locations at the skin surface of the lower limb such that the most optimal motion is obtained.

Task Type 1: Voluntary sitting state tasks without and with external assistance.

Session 1: Voluntary ankle up and ankle down motion without FES. A pair of sEMG sensors will be placed to the participant's lower leg front and back muscles through double-sided tapes. A pair of US imaging transducers will be attached to the same lower-leg front and back muscles to image the muscle's activities during the ankle joint's up and down motion. A pair of movement sensors will be attached to the shank and foot to measure the angular position and velocity of the ankle joint. A force sensor will be placed between the foot sole and a rigid flat platform to measure the interaction force during the ankle up and ankle down motion. US imaging measurements, the electrical signals from sEMG sensors, the contact force from the force sensor, and the movement sensor and camera measurements will be collected simultaneously. Data may be collected from one or both of a participant's legs.

Session 2: Voluntary ankle side motion towards inside and outside without FES. During session 2, the participant will perform side-to-side ankle movements. A similar training procedure, as in session 1, will be prescribed before the actual experiments. Multiple measurements from the sensors (same as in session 1) attached to the participant's leg and foot will be obtained during the side-to-side ankle motion. Both in session 1 and session 2, for each motion direction (up, down, inside, and outside), 10 repeated trials will be run, and each trial will last for 10 mins including training, data collection, data saving, and rest period to avoid muscle fatigue. Each session may last approximately up to 4 hours.

Session 3: Assistive ankle up and down motion with the FES. A similar configuration as mentioned in session 1 will be applied in this session. Additionally, the FES will be used to control the ankle up or down a motion by taking the US imaging-based measurements as feedback. In the FES system, for ankle up motion, the negative electrode will be placed over the muscle belly of the front muscle, while the positive electrode will be placed further down the shank. For ankle down motion, two large electrodes will be used to allow activation of the whole back muscles. These electrodes will be connected to an electrical stimulator, which is controlled via computer software. For both ankle up and ankle down motion, a low current waveform will be used with 100-400 microseconds pulse width and 20-40 Hz frequency. The current range will be between 0-60 mA. In all cases, the pulse duration defined for use will not exceed the upper limit of 400 microseconds. The stimulation parameters used for a participant will be documented for each experimental session and any changes in the stimulation parameters during a session will also be recorded.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

Evaluate the controller performance of human ankle joint

时间窗: Through study completion, an average of 40 months.

The investigators measure the human ankle position \[rad\] and velocity \[rad/sec\] and the desired position \[rad\] and velocity \[rad/sec\] using a commercial sensor encoder when the controller is applied.

Human volitional effort

时间窗: Through study completion, an average of 40 months.

The investigators calculate benchmark human volitional effort (torque \[N-m\]) using inverse dynamics. The investigators predict human volitional effort (torque \[N-m\]) using neuromuscular model and aforementioned outcome measures - sEMG, ultrasound imaging.

次要结局

  • Human body joint kinematics(Through study completion, an average of 40 months.)
  • Ground Reaction Forces(Through study completion, an average of 40 months.)
  • Muscle activation level(Through study completion, an average of 40 months.)
  • Muscle ultrasound image derived measures(Through study completion, an average of 40 months.)

研究者

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

Nitin Sharma

Associate Professor

North Carolina State University

研究点 (4)

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