R01.Aim 2.Study 1: IsoReach

NCT ID: NCT06656754

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-17
• Study Completion Date: 2029-05-01

Brief Summary

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

Detailed Description

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Isometric Reaching condition

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

Group Type: EXPERIMENTAL

Isometric Reaching

Intervention Type: 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

Control Reaching condition

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Isometric Reaching

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 18 years old

No history of stroke

Ability to provide informed consent .

• 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

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:

1. Visual field deficits will be assessed using the BIVABA acuity testing. (cutoff score > 20/100)

2. 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).

4) Blood pressure above 140 systolic and/or 90 diastolic mmHG

5) Blood oxygen reading of less than 92% by finger pulse oximeter testing.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shirley Ryan AbilityLab

OTHER

Sponsor Role: lead

Responsible Party

James Lanphier Patton

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James L Patton, PhD

Role: PRINCIPAL_INVESTIGATOR

Shirley Ryan AbilityLab

Locations

Shirley Ryan AbilityLab

Chicago, Illinois, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Arturo Ramirez

Role: CONTACT

aramire4@uic.edu

312-238-1379

Courtney Celian, OTR/L

Role: CONTACT

Facility Contacts

Courtney Project Manager

Role: primary

ccelian@sralab.org

312-238-1560

Other Identifiers

STU00220740

Identifier Type: -

Identifier Source: org_study_id