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NCT Number: NCT06656754

R01.Aim 2.Study 1: IsoReach

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Courtney Project Manager

CONTACT

[email protected]

312-238-1560

James L Patton, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, neurotypical participants

  • 18 years old

No history of stroke

Ability to provide informed consent .

Exclusion criteria

, 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 test10. (cutoff score > 20/100)

Visual Extinction and Inattention using Star Cancellation Test9. (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.

Treatment and study plan

Isometric Reaching

Other

The intervention of "Isometric Reaching" is the process of restricting the participant's hand movement in place, while using the forces they apply to the robot handle to drive a reaching arm simulation

Primary outcomes

  1. Perpendicular Error

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Arturo Ramirez

CONTACT

[email protected]

312-238-1379

Courtney Celian, OTR/L

CONTACT

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Oct 24, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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