Implementation of IVS3 for Upper Limb Motor Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensive Visual Stimulation Device.
- Who it may be relevant to
- Registry conditions: Neglect, Hemispatial, Stroke, Cardiovascular, Mirror Movement, Motor Activity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Device Intensive 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 a
Primary outcome measures
- Mean number of sessions attended [Time frame: 12 treatment sessions over 4-6 weeks.]
- Number of serious adverse events [Time frame: 12 treatment sessions over 4-6 weeks.]
Secondary outcome measures (2)
- Mean Client Satisfaction Questionnaire-8 [Time frame: Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)]
- Mean System Usability Scale (SUS) [Time frame: Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Weill Cornell Medicine, 525 E. 68th St, Baker Pavilion, F-2106 — New York
Identifiers
NCT: NCT06483230 · 24-04027379