Implementation of IVS3 for Upper Limb Motor Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWeill Medical College of Cornell University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Intensive Visual Stimulation Device
DeviceThe 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Hemi-spatial NeglectExperimental treatment 1 intervention
Group B: No hemi-spatial neglectActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mean number of sessions attended
The primary outcome measure is defined as the mean number of sessions attended of the planned twelve visits. Min 0, Max 12.
Time frame
12 treatment sessions over 4-6 weeks.2
Number of serious adverse events
The primary outcome for safety is defined as the number of serious adverse events that occur while using the IVS3 device.
Time frame
12 treatment sessions over 4-6 weeks.Secondary outcomes
1
Mean Client Satisfaction Questionnaire-8
Feasibility. This tool is a self-report measure participant satisfaction with the intervention. Scored 8-32 with higher scores indicating greater satisfaction.
Time frame
Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)2
Mean System Usability Scale (SUS)
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.
Time frame
Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)Other outcomes
1
Mean Star Ratio on Star Cancellation Test
Screening tool to detect unilateral spatial neglect. The maximum score that can be achieved on the test is 54 points (56 small stars in total minus the 2 used for demonstration). A cutoff of \< 44 indicates the presence of USN. A Laterality Index or Star Ratio can be calculated from the ratio of stars cancelled on the left of the page to the total number of stars cancelled. Scores between 0 and 0.46 indicate USN in the left hemispace. Scores between 0.54 and 1 indicate USN in the right hemispace
Time frame
Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)2
Mean Distance from Midpoint on Line Bisection
Screening tool to detect unilateral spatial neglect. Patients are asked to place a mark with a pencil (with their preferred or unaffected hand) through the center of a series of 18 horizontal lines on an 11x 8.5-inch page. The test is scored by measuring the deviation of the bisection from the true center of the line. A deviation of more than 6 mm from the midpoint indicates USN. Omission of two or more lines on one half of the page indicates USN.
Time frame
Baseline, Post- treatment, 3 months post-treatment.Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)3
Mean Change from baseline Fugl-Meyer Upper Extremity Assessment (FMAUE)
Assessment of upper extremity motor function. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform; 1=performs partially; and 2=performs fully. Score ranges from 0-66 for the upper extremity (22 items).
Time frame
Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)4
Mean Change from baseline Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals who sustained cortical damage resulting in hemiplegia. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement.The ARAT is scored on a four-level ordinal scale (0-3). 0 = can not perform any part of the test, 1 = performs the test partially, 2 = completes the test, but takes abnormally long time, 3 = performs the test normally. Total score ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance.
Time frame
Baseline (Week 1, Visit 1), Post- treatment (Weeks 6-11, Visit 14), 3 months post-treatment (Weeks 18-23, Visit 15)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Weill Medical College of Cornell University
Lead sponsor
Dessintey Inc.
Collaborator
Source ClinicalTrials.gov