R01.Aim 2.Study 1: IsoReach
Shirley Ryan AbilityLab · NCT06656754
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 18+ · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Early Phase 1
- Target enrollment
- 56
- US sites recruiting
- 1
- Study start
- November 17, 2024
- Record last updated
- January 9, 2025
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.
Being studied: Isometric Reaching
Conditions: Stroke
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Shirley Ryan AbilityLab
Chicago, IL 60611
Site contact: Courtney Project Manager · 312-238-1560 · ccelian@sralab.org
Study contacts (from the official record)
- Arturo Ramirez · 312-238-1379 · aramire4@uic.edu
- Courtney Celian, OTR/L
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