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临床试验/NCT05180786
NCT05180786招募中不适用

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Shirley Ryan AbilityLab2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症
干预措施

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
Perpendicular Error

研究概览

简要总结

This study is being done to see how errors lead to improvement. Specifically, we are evaluating the errors stroke participants make during an upper extremity exercise program when reaching for a target using their affected arm. Once we understand the participant's reaching errors, we plan to create a customized reaching exercise according to the individual's specific error tendencies which will lead to better performance on movement ability after training.

详细描述

The neuroplasticity of motor re-learning is a key pathway for recovery in neurorehabilitation. One critical challenge to devising treatment plans for motor recovery is the wide variation that exists between individuals, across movement repetitions, and even within movements. Development of a learning model that looks at these factors would better relate diagnoses to treatments, providing personalization and efficiency to therapy. This proposal aims to advance rehabilitation by building a modeling framework that explores the trends and exploits a fundamental learning process - error. Our goal is to preliminarily test the direct effect of this new treatment in preparation for the randomized controlled study to come. Understanding how error leads to better performance will help us program future devices for therapy for optimal outcomes.

We are using research lab equipment at the Shirley Ryan AbilityLab (SRALab) Hospital's Robotics group. The equipment will be used to implement the reaching exercises and measure participant movement. The equipment includes:

  1. Barret b.u.r.t. arm robot with Teneo forearm attachment
  2. LookingGlass virtual reality display system
  3. Garmin Venu Sq fitness tracking wristwatch

Study Outline:

Week 1, Visit 1: Consent, In-Person Screening, and Baseline Evaluations Participants will sign a consent form. Then, they will undergo a screening process to check if they meet all the eligibility requirements. Participants that pass the in-person screening and agree to continue with the study will complete baseline evaluations which will consistent of upper extremity outcome measures, and a preliminary reaching experiment on the b.u.r.t. robotic arm.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •18 years of age or older
  • •Chronic stroke (8+ months post stroke event) with primary motor cortex involvement
  • •Hemiparesis
  • •Some degree of both shoulder and elbow movement capability

排除标准

  • •Bilateral paresis
  • •Severe tactile deficits using the Two-Point Discrimination Test (participant must detect<11mm)
  • •Severe proprioceptive deficits
  • •Severe spasticity (Modified Ashworth >3) preventing movement
  • •Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment
  • •Visual deficits, and hemispatial neglect that would prevent the subjects from seeing the targets.
  • •Inability to provide an informed consent
  • •severe current medical problems
  • •diffuse/multiple lesion sites or multiple stroke events
  • •Inability to attain and maintain testing positions
  • •Botox injection to the affected upper extremity within the previous 4 months
  • •Concurrent participation in upper extremity rehabilitation either as part of a research intervention protocol or a prescribed therapy
  • •Participation in previous, similar robotics intervention study
  • •Other neurological issues
  • •None of the following special populations will be included in this research study:
  • •Adults unable to consent
  • •Individuals who are not yet adults (infants, children, teenagers)
  • •Pregnant women
  • •Prisoners
  • •Vulnerable Populations

研究组 & 干预措施

Group 1

Other

干预措施: Error Fields (Other)

Group 1

Other

干预措施: No Error Fields (Other)

Group 2

Other

干预措施: Error Fields (Other)

Group 2

Other

干预措施: No Error Fields (Other)

结局指标

主要结局

Perpendicular Error

时间窗: 60-90 minutes

次要结局

  • Action Research Arm Test(5-20 minutes)

研究者

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

James Lanphier Patton

Co-Director, Robotics Laboratory, Arms and Hands Lab, Shirley Ryan AbilityLab

Shirley Ryan AbilityLab

研究点 (2)

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