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临床试验/NCT06999213
NCT06999213尚未招募1 期

Lower Limb ExoNET: Development and Evaluation for Gait Assistance With Stroke Survivors

Shirley Ryan AbilityLab0 个研究点目标入组 20 人开始时间: 2026年1月31日最近更新:

试验速览

阶段
1 期
状态
尚未招募
入组人数
20
主要终点
Electromyography (EMG) amplitude during walking under each intervention condition

研究概览

简要总结

Stroke-related gait impairments, such as poor limb coordination, imbalance, and reduced push-off strength, are often addressed using robotic systems or electrical stimulation, which can be costly, invasive, or insufficient for long-term recovery. Current devices often assist movement but fail to promote functional motor learning. Research supports rehabilitation strategies that amplify gait errors to drive neuroplasticity and adaptation. The LegExoNET (Exoskeletal Network for Elastic Torque) is a novel, passive wearable exoskeleton designed to address this need by enabling both assistive and therapeutic gait training. It stores and releases elastic energy to aid movement while allowing natural joint motion. The system aims to support individuals post-stroke transitioning to independent rehabilitation by offering a lightweight, affordable, and adaptive solution. Initial testing will focus on healthy individuals to assess safety and feasibility before expanding to stroke populations. The LegExoNET has the potential to enhance gait recovery and reduce therapist burden through error augmentation and personalized support, both in clinical and at-home settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

All participants will receive either intervention, but the order in which they receive it will be randomized.

入排标准

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

入选标准

  • Age 18-70 years old
  • Ability to provide informed consent
  • Capable of ambulating without the use of assistive devices for 2 hours

排除标准

  • History of stroke, SCI, or other neurological medical diagnoses
  • Severe medical diagnoses (e.g. cardiovascular, orthopedic)
  • Skin allergies or irritation; open wounds
  • Prisoners
  • Cognitively impaired adults

结局指标

主要结局

Electromyography (EMG) amplitude during walking under each intervention condition

时间窗: Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham)

Muscle activation (specifically voltage amplitude) using wearable surface EMG of the gastrocnemius, lateral gastrocnemius, tibialis anterior, soleus, biceps femoris, rectus femoris, and gluteus maximus.

次要结局

  • 6 Minute Walk Test(Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham))
  • 10 Meter Walk Test(Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham))
  • Gait Symmetry(Day 1 (single study visit); Measured during each intervention condition (Assist, Resist, Sham))

研究者

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

James Lanphier Patton

Principal Investigator

Shirley Ryan AbilityLab

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