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临床试验/NCT07218276
NCT07218276招募中不适用

Passive Robots for Stroke Rehabilitation

University of Michigan2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2025年11月5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
4
试验地点
2
主要终点
Device Survey For Feasibility

研究概览

简要总结

The purpose of this study is to examine the feasibility and effectiveness of a novel, multimodal approach that combines passive devices with noninvasive neuromuscular stimulation for upper extremity rehabilitation after stroke.

详细描述

About 800,000 individuals suffer from a stroke every year in the United States. The majority of stroke survivors often experience lingering deficits in upper extremity function. High-end robotic devices can improve outcomes and clinical productivity; however, these devices are expensive and bulky, making them not practical for many clinical or home environments. This study aims to evaluate the feasibility of low-cost non-motorized devices for stroke rehabilitation in a long-term intervention. The intervention will involve training with a table-top, semi-passive (i.e., no motors) exercise equipment called SepaRRo and commonly-used neuromuscular stimulation. The stimulation will be provided during functional activities using a custom controller (NeuRRoFES) to trigger stimulation. These instruments are designed to provide flexible, compliant assistance/resistance to improve upper extremity function and can be used in a home setting. The study will measure technical feasibility (e.g., qualitative survey, adherence, time on task, retention, ability to perform tasks) as well as clinical feasibility (i.e., changes in biomechanical, neurophysiological, and functional measures) of an intervention with these devices in stroke survivors. The findings aim to support the development of affordable, home-use rehabilitation systems for stroke patients.

研究设计

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

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 75 years;
  • Ischemic or hemorrhagic stroke confirmed by CT, MRI, or clinical criteria;
  • No major deficits of sensation or proprioception;

排除标准

  • Bilateral stroke
  • Unable to think clearly and remember (Mini-Mental State Exam score < 22 and miniMOCA < 8);
  • Uncontrolled Diabetes or Hypertension;
  • Severe limitations of joint range of motion that will lead to inability of testing
  • Severe spasticity and joint contractures that will lead to inability of testing
  • Complete paresis with no possible movements
  • Severe aphasia
  • Any other medical condition that will significantly impact the study results
  • Unable to obtain reliable motor evoked potentials
  • Are pregnant or are actively trying to conceive
  • Have a recent history of repeated fainting spells or syncope.
  • Have a recent history of seizure (epilepsy) while on anti-seizure medication
  • Have a recent history of skull fracture/head injury
  • Have metal implants in the skull
  • Have cardiac pacemakers

结局指标

主要结局

Device Survey For Feasibility

时间窗: Post-intervention (immediately following last session of intervention)

Subjective feedback regarding feasibility of the device for training

次要结局

未报告次要终点

研究者

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

Chandramouli Krishnan

Principal Investigator

University of Michigan

研究点 (2)

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