NCT06656754 · Shirley Ryan AbilityLab
R01.Aim 2.Study 1: IsoReach
What this study is about
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.
View original scientific description
To determine the effects of 3D isometric movement training in healthy participants and impaired participants due to a stroke.
Interventions
OTHER
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
Primary outcome measures
Perpendicular Error
Time frame: through study completion, an average of 1 year.
Maximum distance between the ideal reaching trajectory and the actual trajectory made in unconstrained and constrained movement conditions
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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). 4\) Blood pressure above 140 systolic and/or 90 diastolic mmHG 5\) 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.
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 9, 2025 · Source of record for eligibility and locations