Clinical trial NCT06483230: Implementation of IVS3 for Upper Limb Motor Recovery
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neglect, Hemispatial
Stroke, Cardiovascular
Mirror Movement
Motor Activity
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Dessintey Inc.
First posted: 2024-07-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean number of sessions attended
timeFrame: 12 treatment sessions over 4-6 weeks.
measure: Number of serious adverse events
timeFrame: 12 treatment sessions over 4-6 weeks.
Secondary outcomes:
measure: Mean Client Satisfaction Questionnaire-8
timeFrame: Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
measure: Mean System Usability Scale (SUS)
timeFrame: Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
Other outcomes:
measure: Mean Star Ratio on Star Cancellation Test
timeFrame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
measure: Mean Distance from Midpoint on Line Bisection
timeFrame: 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)
measure: Mean Change from baseline Fugl-Meyer Upper Extremity Assessment (FMAUE)
timeFrame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
measure: Mean Change from baseline Action Research Arm Test (ARAT)
timeFrame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
measure: Mean change from baseline numeric pain rating scale (NPRS)
timeFrame: Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-9, Visit 14), 3 months post-treatment (Weeks 18-21, Visit 15)
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Joan Stilling, MD,MS
role: PRINCIPAL_INVESTIGATOR
References: