Stimulation combined with externally powered motorized orthoses for stroke

刺激结合外部动力电动矫形器治疗中风

• 批准号: 10329995
• 负责人: RONALD J TRIOLO
• 金额: --
• 依托单位: LOUIS STOKES CLEVELAND VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10329995
• 关键词: Abnormal coordination; Acceleration; Activities of Daily Living; Address; Affect; Aging; Algorithms; Ankle; Back; Clinical; Clinical Trials; Communities; Consumption; Data; Detection; Development; Device Designs; Devices; Disabled Persons; Evaluation; Event; Exercise; Extensor; Family; Family member; Feedback; Flexor; Future; Gait; Goals; Health Benefit; Hemiplegia; Hip region structure; Home; Hybrids; Individual; Intervention; Intuition; Isotonic Exercise; Joints; Knee; Knee joint; Laboratories; Lead; Limb structure; Manuals; Measures; Metabolic; Methodology; Motor; Movement; Muscle; Muscle Weakness; Neuromechanics; Orthotic Devices; Outcome; Outcome Measure; Outcome Study; Output; Pattern; Phase; Population; Preparation; Professional Role; Quality of life; Religion and Spirituality; Research; Resistance; Role; Safety; Self-Help Devices; Societies; Stroke; Surface; System; Systems Development; Testing; Toes; Traumatic Brain Injury; Veterans; Volition; Walking; Work; algorithm development; base; clinically significant; design; design and construction; detector; dexterity; exoskeleton; experience; fall injury; fall risk; feasibility testing; follow-up; foot; functional outcomes; hemiparesis; improved; inclusion criteria; instrument; meetings; military veteran; neural stimulation; neuromuscular stimulation; novel; pilot test; prevent; prototype; rectus femoris; sensor; social; stroke survivor; synergism; walking speed

Objective - The objective of this study is to implement and test a neuro-mechanical gait assist (NMGA) device to correct gait characterized by muscle weakness, incoordination or excessive tone in veterans with hemiplegia from stroke that adversely affect their ability to walk, exercise, perform activities of daily living, and participate fully in personal, professional and social roles. Research Plan – Prototype NMGA device will be used to develop a finite state controller (FSC) to coordinate user’s volitional effort coordinated with surface muscle stimulation and motorized knee assist as needed. Brace mounted sensors will be used to develop gait event detector (GED) which will serve the FSC to advance through the phases of gait or stair climbing. In addition, a supervisory rule-base intent detection algorithm will be developed using brace mounted sensors and user interface input to select among various functions including walking, stairs climbing, sit-to-stand and stand-to-sit maneuvers. The FSC controller tuning and intent algorithm development and evaluation will be on three pilot subjects with gait deficits from stroke. Outcome measures during development will provide specifications for a new prototype NMGA design which will be evaluated on three pilot subjects to test hypothesis that NMGA improves walking speed, distance and energy consumption of walking. These baseline data and device will be used to design a follow-up clinical trial to measure orthotic impact of NMGA on mobility in activities of daily living at home and community. Methodology – After meeting inclusion criteria, pilot subjects will undergo baseline gait evaluation with EMG activities of knee flexors and extensors, ankle plantar and dorsiflexors and isokinetic knee strength and passive resistance. They will be fitted with NMGA combining knee-ankle-foot-orthosis with motorized knee joint and four channels of surface neuromuscular stimulation of plantar- and dorsi- flexors, vasti and rectus femoris. Brace mounted sensor data will be used for gait event detector (GED) algorithm development and evaluation. GED will serve FSC to proceed through phases of gait based on supervisory rule-based user intent recognition algorithm detected by brace mounted sensors and user input interface. FSC will coordinate feed-forward control of tuned stimulation patterns and closed-loop controlled knee power assist as needed to control foot clearance during swing and stability of the knee during stance. Based on data attained during controller development and evaluation, a new prototype NMGA will be design, constructed and evaluated on three pilot subjects to test hypothesis that NMGA device improves safety and stability, increases walking speed and distance and minimizes user effort. For all experimental conditions, a statistical power of 90% was used to determine the number of repetitions required in the single subject design to detect statistically significant or 0.2m/s minimal clinically important improvement in walking speed. Clinical Significance - The anticipated outcome is improved gait stability with improved swing knee flexion, thus, increasing the safety and preventing injurious falls of ambulatory individuals with hemiplegia due to stroke found in large and ever-increasing numbers in the aging veteran population. Correcting gait should lead to improved quality of life and participation.

目的-本研究的目的是实现和测试一种神经机械步态辅助（NMGA）装置