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临床试验/NCT06656754
NCT06656754招募中1 期

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Shirley Ryan AbilityLab1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2024年11月17日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
招募中
入组人数
56
试验地点
1
主要终点
Perpendicular Error

研究概览

简要总结

To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.

详细描述

Researchers have found that neurotypical adults are able to train movement skills when sensory sources, such as proprioception, are altered using isometric conditions and visual feedback in a two-dimensional environment.Building off this knowledge, the investigators plan to apply similar techniques to both neurotypical adults and stroke survivors with impaired movement, but in a three-dimensional environment. The investigators will ask participants to practice a unilateral virtual reality targeted reaching task using a robotic arm in a 3D visual display system mounted over the arm. Participants will be given visual feedback of their arm through a virtual avatar displayed on the screen. First, they will complete unconstrained targeted reaching and then complete targeted reaching with the robotic arm constrained in a fixed position ("isometric" movement). The forces applied to constrain the robotic arm will be translated to the virtual avatar arm on the screen, and it will look as if their arm is moving. The investigators will compare perpendicular errors (maximum difference between the ideal reaching trajectory and the actual) made in unconstrained and constrained movement conditions. The investigators aim to determine if the two movement conditions yield similar error responses when sensory sources are altered in a 3D environment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, 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

  • •, neurotypical participants
  • •18 years old
  • •No history of stroke
  • •Ability to provide informed consent .

排除标准

  • •, neurotypical participants
  • •Severe medical problems (including cardiovascular, orthopedic, or neurological)
  • •Medical problems affecting movement, range of motion, strength, or coordination of the upper extremities.
  • •Visual deficits that would influence the ability to perform the experiment . This will be assessed using the following assessments:
  • •Visual field deficits will be assessed using the BIVABA acuity testing. (cutoff score > 20/100)
  • •Depth perception deficits will be assessed using the Stereofly test (require at least an angle of stereopsis at 16 inches is 3,552 seconds of arc).
  • •Blood pressure above 140 systolic and/or 90 diastolic mmHG
  • •Blood oxygen reading of less than 92% by finger pulse oximeter testing.
  • •Inclusion Criteria , Stroke participants
  • •18 years old
  • •Chronic stroke (8+ months post)
  • •Available medical records and radiographic information about lesion locations
  • •Hemiparesis
  • •Primary motor cortex involvement
  • •Some degree of both shoulder and elbow movement capability
  • •Exclusion Criteria , Stroke participants
  • •Bilateral paresis
  • •Aphasia, cognitive impairment, or affective dysfunction that would influence the ability to perform the experiment, This will be assessed using the Mini Mental State Examination31, with cut-off scores (adjusted for education level) as follows:
  • •Participants whose education are 7th grade or lower, a score 22 or lower
  • •Participants whose education attainment level is 8th grade or some high school (but not a graduate), a score of 24 or lower
  • •Participants whose education attainment level is high school graduate, a score of 25 or lower
  • •Participants whose education attainment level is some college or higher, a score 26 or lower
  • •Visual deficits, and hemispatial neglect that would prevent the participants from seeing the targets. A vision test will be done if the participant indicates in their screen that their stroke has affected their vision. This will be tested using the following assessments:
  • •Visual field loss will be assessed using the BIVABA acuity test
  • •(cutoff score > 20/100)
  • •Visual Extinction and Inattention using Star Cancellation Test
  • •(cutoff score of <44)
  • •Depth perception deficits will be assessed using the Stereofly test (require at least an angle of stereopsis at 16 inches is 3,552 seconds of arc).
  • •Modified Ashworth score of 4 at shoulder or elbow joints.
  • •Rated below 15 on the FMUE scale
  • •Inability to provide an informed consent
  • •severe current medical problems
  • •Severe sensory deficit in the affected limb (Cannot be absent in any part of affected UE)
  • •diffuse/multiple lesion sites or multiple stroke events
  • •Inability to attain and maintain testing positions
  • •Botox or other botulinum toxin 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
  • •Neurological, neuromuscular, or orthopedic diseases (i.e. injuries to your affected arm or hand)
  • •Other neurological issues (Parkinson's, CP)
  • •Blood Pressure above 140 systolic and/or 90 diastolic mmHg
  • •Blood oxygen reading of less than 92% on finger pulse oximetry testing.

研究组 & 干预措施

Isometric Reaching condition

Experimental

In this arm the participant participates in "Isometric Reaching" in which they are not allowed to freely reach to the target, instead the forces they apply on the robot handle drives a reaching arm simulation

干预措施: Isometric Reaching (Other)

Control Reaching condition

No Intervention

In this condition the participant moves toward target freely and the visual feedback is based on hand position and not an arm simulation.

结局指标

主要结局

Perpendicular Error

时间窗: through study completion, an average of 1 year.

Maximum distance between the ideal reaching trajectory and the actual trajectory made in unconstrained and constrained movement conditions

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

James Lanphier Patton

Principal Investigator

Shirley Ryan AbilityLab

研究点 (1)

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