A Pilot Study on Tolerance and Ease of Implementation of Intensive Visual Stimulation (IVS3) in Daily Practice for Upper Limb Motor Recovery in Outpatient Rehab Center
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 25
- Locations
- 1
- Primary Endpoint
- Number of serious adverse events
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •English speaking
- •History of ischemic or hemorrhagic stroke ≥ 6 months prior to study enrolment
- •FMA-UE: 20 \< x \< 50 (moderate impairments)
- •With or without hemi spatial neglect
Exclusion Criteria
- •Spasticity or increased tone with MAS ≥3 in the upper extremity
- •Unable to communicate effectively or provide informed consent
- •Significant visual impairments
- •Concurrent occupational therapy being received outside of the study
- •Pregnant or incarcerated individuals
Outcomes
Primary Outcomes
Number of serious adverse events
Time Frame: 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
Time Frame: 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 Outcomes
- Mean Client Satisfaction Questionnaire-8(Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15))
- Mean System Usability Scale (SUS)(Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15))