Virtual Reality Glove for Hand and Arm Rehabilitation After Stroke

The Neofect Smart Glove is a commercially available, non-invasive biofeedback based system
for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for
easy movement of all distal upper extremity joints. It consists of a glove-shaped sensor
device and a software application which can be used with either a large screen or a portable
tablet. The system includes multiple ADL-based training games, and the system tracks the
motion and posture of the wearer's distal limb as they participate. Games can be selected to
focus on certain movements (such as forearm pronation/supination, wrist flexion/extension,
finger flexion/extension, etc.) based on the needs of the wearer. The software includes a
smart learning algorithm, in which the computer automatically adjusts to the optimal level of
difficulty to balance challenge and motivation. After initial set-up, the device requires no
therapist supervision to use.

Patients will be eligible for the study if they are (1) within 30 days from an ischemic or
hemorrhagic stroke (with aim for enrollment within 1 week post stroke), and (2) have impaired
arm/hand function secondary to the stroke (see below for specific inclusion and exclusion
criteria). We will recruit eligible patients from acute care hospitals, acute rehabilitation
units, and outpatient facilities. Enrolled patients will be randomized (1:1 ratio) to
standard rehabilitation therapy versus standard rehabilitation therapy plus Smart Glove use.
All patients will be allowed to participate in any scheduled outpatient rehabilitation during
the study.

The study consists of a 12-week intervention period and a 12-week follow-up period. During
the 12-week intervention period all patients will receive their usual rehabilitation therapy,
with their therapists documenting rehabilitation dose in a journal provided at the start of
the study. In addition, subjects randomized to the Smart Glove therapy arm will be provided
with a Smart Glove system, which includes the glove and tablet. Subjects will be instructed
to use the system for at least one session per day for 5 days per week during the 12-week
intervention period. Participants will present for in-person visits on weeks 6, 12, and 24
for blinded assessments by study coordinators. At the completion of the intervention period,
subjects will return the Smart Glove and subjects in both arms of the study will only receive
usual care during the 12-week follow-up period. Subjects will have a final assessment at week
24 (12 weeks after completing the intervention) to assess for persistence of effect.

All efficacy analyses are analyzed under the intention to treat principle. The primary
efficacy outcome is the change in score on the Jebsen Taylor Hand Test between baseline and
week 12. Secondary efficacy endpoints are changes in scores on the upper extremity Fugl-Meyer
Scale, Stroke Impact Scale, and total dose of rehabilitation received during the 24-week
intervention period. Persistence of the treatment effect will be tested by comparing changes
in scores on the Jebsen Taylor Hand Test and Fugl-Meyer upper extremity score at 24 weeks
between treatment groups

Inclusion Criteria:

- a diagnosis of ischemic or hemorrhagic stroke within 30 days prior to enrollment.

- unilateral hand/arm weakness from stroke with indication for upper limb rehabilitation
therapy.

- ability to successfully play 2 out 4 pre-selected test games with the Smart Glove. The
test specific games and criteria for passing are as follows:

- Pour the wine (Pronation/Supination): make 5 pours in first 1 minute

- Snow Ball Fight (Wrist Flexion/Extension w/ gravity eliminated): take down 3
objects in first 1 minute

- Scrub the Floor (Wrist Radial/Ulnar deviation w/ gravity eliminated): scrub the
floor 5 times in first 1 minute

- Float the Fish (Finger Flexion/Extension): make 50 meters with 3 or less bumps in
first 3 minutes

Exclusion Criteria:

- Age <18 years

- history of visually provoked seizures

- psychological disorder that could impede participation

- pre-existing neurologic disorder which causes significant deficits in arm/hand
function (e.g. Parkinson's disease, peripheral neuropathy, etc.)

- severe receptive aphasia which results in inability to participate with the Smart
Glove.

- cognitive impairment which results in inability to participate with the Smart Glove.

- severe pain impeding upper extremity rehabilitation and use of the Smart Glove

- limited life-expectancy which makes it unlikely that patient will be able to complete
the 24-week follow-up visit

- any medical or other condition that, in the opinion of the investigator, makes the
patient unsuitable for participation in this study.