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Behavioural Intervention
Visual Stimulation for Stroke Recovery
N/A
Recruiting
Led By Joan Stilling, MD,MS
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years old
Be older than 18 years old
Must not have
Unable to communicate effectively or provide informed consent
Spasticity or increased tone with MAS ≥3 in the upper extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, post- treatment, 3 months post-treatment.baseline (week 1, visit 1), post- treatment (weeks 6-9, visit 14), 3 months post-treatment (weeks 18-21, visit 15)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if using the IVS3 device can help improve satisfaction and arm function in patients with chronic stroke. Researchers believe that using the IVS3 device will be manageable and well-t
Who is the study for?
This trial is for English-speaking adults over 18 who had a stroke at least 6 months ago, with moderate upper limb impairments. It's not for those with severe muscle stiffness in the arm, significant vision problems, current pregnancy or incarceration, or if they're getting similar therapy outside the study.
What is being tested?
The trial is testing a device called IVS3 on outpatients who have had a stroke. The goal is to see if using this device helps improve satisfaction and function of the upper limbs (like arms and hands) after chronic stroke.
What are the potential side effects?
Since it's not mentioned specifically in the provided information, side effects are likely minimal but may include discomfort from using the device or fatigue during intensive visual stimulation sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I can communicate effectively and provide informed consent.
Select...
My arm is very stiff or has spasms, with a score of 3 or more.
Select...
I have major issues with my vision.
Select...
I am currently receiving occupational therapy not related to this study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, post- treatment, 3 months post-treatment.baseline (week 1, visit 1), post- treatment (weeks 6-9, visit 14), 3 months post-treatment (weeks 18-21, visit 15)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, post- treatment, 3 months post-treatment.baseline (week 1, visit 1), post- treatment (weeks 6-9, visit 14), 3 months post-treatment (weeks 18-21, visit 15)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Mean number of sessions attended
Number of serious adverse events
Secondary study objectives
Mean Client Satisfaction Questionnaire-8
Mean System Usability Scale (SUS)
Other study objectives
Mean Change from baseline Action Research Arm Test (ARAT)
Mean Change from baseline Fugl-Meyer Upper Extremity Assessment (FMAUE)
Mean Distance from Midpoint on Line Bisection
+2 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Hemi-spatial NeglectExperimental Treatment1 Intervention
Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.
Group II: No hemi-spatial neglectActive Control1 Intervention
Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.
Find a Location
Who is running the clinical trial?
Dessintey Inc.UNKNOWN
Weill Medical College of Cornell UniversityLead Sponsor
1,091 Previous Clinical Trials
1,154,721 Total Patients Enrolled
Joan Stilling, MD,MSPrincipal InvestigatorWeill Medical College of Cornell University