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临床试验/NCT05520359
NCT05520359招募中不适用

Transcutaneous Stimulation and Mobility Device Use for Individuals With Neurologic Conditions

University of Washington2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月4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
20
试验地点
2
主要终点
Muscle Coordination

研究概览

简要总结

This research study will combine non-invasive spinal stimulation with mobility devices to examine the acute impact of the individual and combined effects of these innovative techniques on mobility in children with cerebral palsy.

详细描述

For people with neurological conditions, excessive and inappropriate muscle activity resulting from injured sensory pathways (e.g., spasticity or hypertonicity) contributes to inefficient movement, bone deformities, pain, and other comorbidities. Research with humans and animals have highlighted the critical importance of both motor and sensory pathways for motor learning after neurologic injury. However, the best techniques for engaging motor and sensory pathways in a way that brings high quality mobility are not well understood. With this study we will examinee how increased sensory feedback, through mobility device use and electrical spinal stimulation, impact movement mechanics in people with neurological conditions to inform long-term studies and eventual implementation into clinical practice.

Mobility devices offer a promising approach to improve mobility rehabilitation through engagement of sensory and motor pathways. These devices can either assist in movement by providing support to perform an activity or they can be used to provide resistance to build strength. Mechanistically how these devices impact movement mechanics is still not well understood.

Electrical spinal stimulation with intensive, repetitive training has demonstrated exciting potential to improve limb function after neurologic injury. Spinal stimulation has shown to improve motor function with long-term training. Stimulation is hypothesized to improve motor pathways through boosting sensory input. However, the neuromechanical effects of stimulation as a result of increased sensory feedback over an acute time frame has not been explored in efforts to test this hypothesis.

This study aims to evaluate the acute effects of increased afferent feedback in individuals with neurological conditions via mobility devices and spinal stimulation. Understanding how these approaches affect the quantity and quality of movement in the short term is a first step before determining potential treatment outcomes. In this research, we will quantify the neuromechanics of movement with and without these approaches for individuals with neurologic disorders.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
4 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have a neurologic condition
  • are 4-70 years of age
  • have stable medical condition
  • can perform simple cued motor tasks and who can follow 2-3 step commands
  • who are volunteering to be involved in this study
  • can provide feedback on comfort and experience during lab visits

排除标准

  • have significant medical disease; including uncontrolled systemic hypertension with values above 170/100 mmHg; cardiac or pulmonary disease; uncorrected coagulation abnormalities or need for therapeutic anticoagulation.
  • have cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention
  • have a history of uncontrolled seizures
  • have unhealed fracture or other musculoskeletal impairment that might interfere with lower extremity rehabilitation or testing activities
  • are dependent on ventilation support
  • have implanted stimulator (e.g. epidural stimulator, vagus nerve stimulator, pacemaker, cochlear implant, etc) or drug delivery device (e.g. baclofen pump)
  • have history of orthopedic surgery in lower extremities or neurosurgery that may be a confounding factor for interpretation of the results (such as tendon transfer, tendon or muscle lengthening for spasticity management, injection therapies to lower extremity muscles, etc.) in last 12 months
  • have established osteoporosis and taking medication for osteoporosis treatment.
  • have rheumatic diseases (rheumatoid arthritis, systemic lupus erythematosus, etc.)
  • have active cancer

结局指标

主要结局

Muscle Coordination

时间窗: Comparing first and last minute of walking on treadmill at each experimental session.

Change in level of co-contraction between the plantarflexor and tibialis anterior muscles during the gait cycle monitored from electromyography recordings.

次要结局

  • Modified Ashworth Scale(Physical exam conducted at the beginning and end of each experimental session.)
  • Plantarflexor Muscle Strength(Physical exam conducted at the beginning and end of experimental session.)

研究者

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

Katherine Steele

Professor, Mechanical Engineering

University of Washington

研究点 (2)

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