Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke

In this pilot study, we propose to test a virtual reality home-based intervention as an
alternative or supplement to traditional rehabilitation for upper extremity weakness after
stroke. We are hoping to discover that the device is easily adopted by patients and increases
the dose of rehabilitation, as well as potentially leads to motor recovery.

With the increasing affordability and accessibility of virtual reality (VR) systems, VR has
emerged as a new platform for stroke rehabilitation. VR therapy involves using computer-based
programs to simulate daily tasks and events. VR has shown promise in both allowing patients
to practice activities that directly translate to their ADLs, as well as motivating them by
providing a novel and interesting virtual environment.

Relevance Regaining upper extremity function is very important for stroke survivors to
increase their independence and ability to perform ADLs. The large majority of outpatient
stroke rehabilitation currently takes place in a therapy clinic, however access is often
limited by resource allocation, financial hardship, and transportation difficulties. The
Smart Glove can provide an inexpensive and convenient means for stroke patients to continue
their rehabilitation in the comfort of their own home.

Patient Population Subacute and chronic stroke patients presenting with upper extremity
weakness, as identified by Stanford physicians in clinic, will be eligible for participation
in this study. Patients will be screened and selected from the population of people with
strokes who are seen in the Stanford Neuroscience Clinic. Patients will be allowed to
participate in any scheduled outpatient rehabilitation during the study. The doctor and/or
research coordinator may introduce the study to potential candidates in-person in the
Stanford Neurology Clinic, and the research coordinator may contact potential candidates by
phone after the doctor's referral.

Procedures:

Once the participant has given informed consent and enrolled in the study, they will have a
total of five visits, with one visit every two weeks.

Visit one will entail the participant and identified caregiver undergoing training on the use
of the Smart Glove by the research coordinator and Neofect staff. This involves
donning/doffing of the glove as well as instruction as to how to use the software program.
The participant will be issued a Smart Glove and a tablet preloaded with the software.
Subjects will also undergo baseline functional testing, including manual muscle testing
(MMT), Fugl-Meyer assessment (FM), Jebson-Taylor hand function test (JTT), and Stroke Impact
Scale (SIS). This first visit is expected to take 60-90 minutes. The participant will be
expected to use the Smart Glove for 60 min per day for at least 5 days per week.

The subsequent three visits will be at two week intervals and will involve the participant
bringing the device to the CTRU. The research coordinator will upload the data from the
device as well as troubleshoot any device-related issues. These visits will last 15-30
minutes each.

The final visit will occur after eight weeks of Smart Glove use. In addition to downloading
the data, the research coordinator will also repeat functional testing functional testing,
including manual muscle testing (MMT), Fugl-Meyer assessment (FM), Jebson-Taylor hand
function test (JTT), and Stroke Impact Scale (SIS). This visit will last 45-60 minutes.

Inclusion Criteria:

- 1) Age 18 and older 2) Diagnosis of stroke at least three months prior to enrollment
3) Unilateral upper extremity functional deficit after stroke 4) Presence of a score
of at least 2 points on the medical research council scale for wrist flexion/extension
or forearm pronation/supination 5) Able to provide informed consent 6) Caregiver who
is willing to be trained in use of the Smart Glove

Exclusion Criteria:

- 1) Predisposing psychological disorders which could impede participation 2) Severe
aphasia resulting in communication difficulties 3) Severe pain impeding upper
extremity rehabilitation 4) Pre-existing neurological disorder that causes motor
deficits (i.e. Parkinson's disease)