Implementation of IVS3 for Upper Limb Motor Recovery

Not Applicable

Recruiting

• Conditions: Neglect, Hemispatial; Mirror Movement; Stroke, Cardiovascular; Motor Activity
• Interventions: Device: Intensive Visual Stimulation Device

• Registration Number: NCT06483230
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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.

Detailed Description

This study will investigate the implementation of the intensive visual stimulation three (IVS3) device in the outpatient rehabilitation setting. This is a phase I/II open label study that will assess participant satisfaction and upper extremity function in outpatients with chronic stroke (10 with hemi spatial neglect and 15 without), when exposed to IVS3 for 30 minutes and conventional treatment for 15 minutes, across 12 sessions in 4-6 weeks at Weill Cornell medicine outpatient rehabilitation (single site).

Study Timeline

• Study First Submitted: 2024-06-24
• Study First Submitted QC: 2024-06-28
• Study First Posted: 2024-07-03
• Study Start: 2024-10-02
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-25
• Primary Completion: 2027-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemi-spatial Neglect	Intensive Visual Stimulation Device	Individuals with stroke with hemi-spatial neglect as identified on the star cancellation and line bisection tests.
No hemi-spatial neglect	Intensive Visual Stimulation Device	Individuals with stroke without hemi-spatial neglect as identified on the star cancellation and line bisection tests.

Primary Outcome Measures

Name	Time	Method
Number of serious adverse events	12 treatment sessions over 4-6 weeks.	The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device.
Mean number of sessions attended	12 treatment sessions over 4-6 weeks.	The primary outcome measure is defined as the mean number of sessions attended of the planned twelve visits. Min 0, Max 12.

Secondary Outcome Measures

Name	Time	Method
Mean Client Satisfaction Questionnaire-8	Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)	Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
Mean System Usability Scale (SUS)	Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)	Feasibility. This tool is a subjective therapist usability measure assessing satisfaction with implementation of the intervention. It is a 10 item likert scale, scored 0-100, with higher scores indicating greater satisfaction.

Trial Locations

Locations (1)

Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106; 🇺🇸 New York, New York, United States