Mirror Movement, Motor Activity, Neglect, Hemispatial, Stroke, Cardiovascular
Conditions
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).
Interventions
DEVICEIntensive Visual Stimulation Device
The therapist installs the patient in front of the device. First, patient puts the healthy side on the table and the therapist records several movements. The software of the device flips the video in order to create a mirrored image of the movement (pretty close to the mirror therapy approach). When all the movements are recorded, patient installs the affected side on the table and the screen is placed over the hand. Likewise, patient has the impression the hand is moving again. Thanks to this action observation principle, therapist can encourage the patient in trying to move again and increase brain plasticity.
Sponsors
Weill Medical College of Cornell University
Dessintey Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Client Satisfaction Questionnaire-8 | Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, 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 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, 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. |
Countries
United States
Contacts
CONTACTChristian Ponce Garcia, BS
PRINCIPAL_INVESTIGATORJoan Stilling, MD,MS
Weill Medical College of Cornell University
Outcome results
None listed