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Taking people in United StatesEarly phase 1

Tests isometric reaching training in people with stroke and healthy adults

Studies how 3D isometric movement training affects healthy adults and people impaired by stroke.

Plain-language title generated from the registry record
Registry title: R01.Aim 2.Study 1: IsoReach

Key facts

Where
Chicago, United StatesSee the site
Phase
Early phase 1

Where in United States

  • Shirley Ryan AbilityLabChicago, United StatesTaking people

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Trial details

Who runs it
Shirley Ryan AbilityLab
Trial code
NCT06656754
Record updated
9 January 2025
Original description
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.Read full original descriptionShow less

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

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

Inclusion: 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: 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; 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:; 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:; diffuse/multiple lesion sites or multiple stroke events; Neurological, neuromuscular, or orthopedic diseases (i.e. injuries to your affected arm or hand); 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; Bilateral paresis; 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 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); Inability to attain and maintain testing positions; 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.

ClinicalTrials.gov NCT06656754