R01.Aim 2.Study 1: IsoReach

NCT06656754 | Recruiting Early Phase 1

• 1 other identifier: STU00220740
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Perpendicular Error

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

  through study completion, an average of 1 year.

Study Arms (2)

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

Other: Isometric Reaching

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.

Interventions

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

Isometric Reaching condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• No history of stroke
• Ability to provide informed consent .

You may not qualify if:

• 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.
• 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
• 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:

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• James L Patton, PhD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arturo Ramirez

CONTACT

312-238-1379; aramire4@uic.edu

Courtney Celian, OTR/L

CONTACT

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: October 24, 2024
• Study Start: November 17, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

US (1)