跳至主要内容
临床试验/NCT07616167
NCT07616167尚未招募不适用

From Stroke Rehabilitation to Independence: An Impairment-Aware Control Framework for Adaptive Exoskeleton Assistance

University of Michigan1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
20
试验地点
1

研究概览

简要总结

The goal of this clinical trial is to test a new, impairment-aware robotic control software framework to see if its smart adaptation can improve walking recovery in healthy adults and chronic stroke survivors. .

The main questions it aims to answer are:

Can the new control software safely use sensors and machine learning to predict and instantly adapt to a user's specific walking needs?

Does training with a robotic device driven by this new adaptive control framework improve walking speed and overall mobility in stroke survivors?

Researchers will compare a lower-limb orthosis operating under the new "smart" control software (which adapts to the user's impairment) to the same device operating under a standard, non-adaptive controller (which uses rigid or fixed assistance) to see if the new control approach leads to greater improvements in walking ability.

Participants will:

Walk on treadmills, flat walkways, or stairs while wearing a robotic leg orthosis driven by the different control software systems being tested.

Wear small tracking tools (like reflective motion-capture markers and muscle activity sensors) so researchers can precisely measure how their movements interact with each control program.

Complete standard walking tests to measure their walking speed and overall mobility under each software condition.

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
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cohort 1: Able-Bodied Participants (Initial Validation)
  • Healthy young adults.
  • No history of neurological, orthopedic, or cardiovascular impairments affecting gait or balance.
  • Able to walk independently without assistive devices.
  • Cohort 2: Stroke Survivors (Clinical Efficacy Pilot)
  • Individuals with a documented history of chronic stroke.
  • Persistent unilateral lower-limb motor impairment resulting in a pathological gait pattern (heterogeneous gait deficits).
  • Stable medical condition allowing for participation in intensive physical rehabilitation tasks.
  • Able to provide informed consent.

排除标准

  • Severe cognitive or communication impairments that prevent the participant from following safety instructions or reporting discomfort.
  • Co-existing neurological conditions (other than stroke) that independently impair locomotion (e.g., Parkinson's disease, Multiple Sclerosis).
  • Severe lower-limb joint contractures or orthopedic conditions that mechanically restrict the safe range of motion of the robotic orthosis.
  • Skin breakdowns, open wounds, or severe unhealed lesions at the contact points where the powered orthosis interfaces with the lower limbs.
  • Any medical contraindication to intensive walking exercise or treadmill training (e.g., unstable angina, severe unmanaged cardiovascular disease).

研究者

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

Robert D Gregg

Professor

University of Michigan

研究点 (1)

Loading locations...

相似试验