Implementation of IVS3 for Upper Limb Motor Recovery

NOT_YET_RECRUITING

I'm interested ...!!

This study measures participant satisfaction and upper extremity function in outpatients with chronic stroke when exposed to the IVS3 device. Investigators hypothesize that treatment with the IVS3 device will be feasible and tolerable for use in the outpatient setting.

Conditions:

🦠 Neglect, Hemispatial 🦠 Stroke, Cardiovascular 🦠 Mirror Movement 🦠 Motor Activity

🗓️ Study Start (Actual) September 2024

🗓️ Primary Completion (Estimated) March 2027

✅ Study Completion (Estimated) June 2027

👥 Enrollment (Estimated) 25

🔬 Study Type INTERVENTIONAL

📊 Phase NA

Locations:

📍 New York, New York, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

1. Age ≥ 18 years old
2. English speaking
3. History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
4. FMA-UE: 20 \< x \< 50 (moderate impairments)
5. With or without hemi spatial neglect

Exclusion Criteria:

1. Spasticity or increased tone with MAS ≥3 in the upper extremity
2. Unable to communicate effectively or provide informed consent
3. Significant visual impairments
4. Concurrent occupational therapy being received outside of the study
5. Pregnant or incarcerated individuals

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 24 June 2024
First Submitted that Met QC Criteria 28 June 2024
First Posted 3 July 2024

Study Record Updates

Last Update Submitted that Met QC Criteria 28 June 2024
Last Update Posted 3 July 2024
Last Verified June 2024