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NCT06656754RecruitingEarly phase 1

R01.Aim 2.Study 1: IsoReach

Error-enhanced Learning & Recovery in 2 & 3 Dimensions

Source: ClinicalTrials.gov · Last updated 9 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
56 (estimated)
First submitted
4 Sept 2024
Start date
17 Nov 2024
Primary completion date
1 May 2029
Lead sponsor
Shirley Ryan AbilityLab
Diseases
Stroke
NCT number
NCT06656754

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 56
  • From 17 Nov 2024 to the primary completion date, 1 May 2029
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • 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)

Other

  • 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).
    • 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
  • 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.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Shirley Ryan AbilityLab
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.