Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in Subacute and Chronic Stroke
Phase: NA
Conditions: Stroke
Sponsor: Stanford University

 
 
Feasibility of Home-based Virtual Reality Rehabilitation for the Upper Extremity in 
Subacute and Chronic Stroke 
 
Study Protocol 
 
NCT03559829 
 
 
September 23, 2016 
 
 

The Feasibility of Home-Based Virtual Reality Rehabilitation for the Upper Extremity in Subacute 
and Chronic Stroke Study seeks to explore the safety, usability, and efficacy of a home based 
virtual reality biofeedback system to promote distal upper extremity (wrist and hand) recovery 
after stroke. The purpose of the study is to assess the feasibility of using a  
home-based virtual reality system to increase the dose of upper extremity rehabilitation in  
subacute and chronic stroke patients. 
 
BACKGROUND 
 
Stroke 
Every year over 700,000 people in the US suffer at stroke. Upper extremity impairment is very 
common after stroke, and 15-30% of stroke survivors experience ongoing weakness in the 
affected arm (Van der Lee et al., 1999).  The most common motor disorder which occurs after 
stroke is paresis, which is the inability to voluntarily activate motor neurons (Sathian et al., 
2011).  
 
Distal upper extremity strength is required to complete a number of activities of daily living 
(ADLs), including feeding, grooming, dressing, writing, and typing. The ability to perform such 
ADLs is strongly tied to quality of life (QOL) in stroke survivors (Wolf et al., 2006). However, 
even after intensive rehabilitation of the upper extremity, only 5-20% of patients achieve 
complete functional recovery (Nakayama et al., 1994).  
 
Recent interventions for upper extremity rehabilitation in stroke including constraint induced 
movement therapy (CIMT) and robotic therapy. Constraint induced movement therapy involves 
immobilization of the non-paretic arm for 90% of waking hours and high-repetition task 
oriented training for at least six hours per day. Despite early studies showing some promise for 
motor recovery, a recent meta-analysis of 38 articles concluded that the evidence for the 
superiority of CIMT in comparison with other rehabilitative interventions is weak (Etoom et al., 
2016). 
 
Robot assisted arm training involves either passive movement of the affected upper extremity, 
or partial assistance through a movement pattern using an electromechanical device. Many of 
the robotic devices can also adapt as a patient recovers strength by providing less assistance or 
more complicated movements. While there are a number of such robots on the market, the 
results of studies examining facilitation of motor recovery have been mixed. A recent Cochrane 
Review concluded that robotic use may lead to improvements in strength and ability to perform 
ADLs, however they also cautioned that the quality of evidence was very low (Merholz et al., 
2015). 
 
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. A recent Cochrane Review of VR based rehabilitation 
interventions concluded that it may be beneficial in improving upper limb function and ADL 
function, though it is unknown if these gains are sustained in the long term (Laver et al., 2015). 
 
The RAPAEL Smart Glove is a biofeedback device designed for distal upper extremity 
rehabilitation in stroke survivors. 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. There are 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.  
 
A recent single-blinded, randomized controlled trial of 46 stroke survivors compared the Smart 
Glove combined with standard occupational therapy (OT) to dose matched conventional upper 
extremity OT. The primary outcome was change in the Fugl-Meyer (FM) assessment, with 
secondary outcomes including fine motor tasks and quality of life (QOL) measurements. The 
study found greater improvements in motor impairment and QOL in the Smart Glove group 
(Shin et al., 2016). 
 
Primary Hypothesis 
The Neofect Smart Glove VR system will be easily adopted for home-based use, and will 
increase the dose of upper extremity rehabilitation received by patients with subacute and 
chronic stroke.  
 
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. 
 
Study Sites 
The Stanford University Medical Center will be the Coordinating Center for this study. 
Stanford’s CTRU and the Neurology Outpatient Clinic will be used for study visits and 
assessments. 
 
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) 
 
Study Procedures: 
Once the participant has given informed consent and enrolled in the study, they will come to 
Stanford’s CTRU or the Neurology outpatient clinic for 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. 
 
 
 
Fig 1: The RAPAEL Smart Glove™ system and the task-specific games of this system 
 
Protocol Summary: 
 
Day 0: 
 Research coordinator with review the research consent form in detail with the 
participant and answer any questions about the study. After consent, the participant 
will be enrolled in the study. 
Day 1: 
 Smart Glove training for patient and caregiver 
 Issuance of Smart Glove and tablet with preloaded software 
 Baseline testing of the affected extremity: 
o Manual muscle testing (MMT)  
o Fugl-Meyer assessment (FM) 
o Jebson-Taylor hand function test (JTT) 
o Stroke Impact Scale (SIS) 
Day 14: 
 Download of patient use data from tablet 
 Troubleshooting 
Day 28: 
 Download of patient use data from tablet 
 Troubleshooting 
Day 42: 
 Download of patient use data from tablet 
 Troubleshooting 
Day 56: 
 Download of patient use data from tablet 
 Testing of the affected extremity: 
o Manual muscle testing (MMT)  

o Fugl-Meyer assessment (FM) 
o Jebson-Taylor hand function test (JTT) 
o Stroke Impact Scale (SIS) 
 
Neofect Smart Glove Device Description 
 
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 is made of an elastomer material that is simple 
to maintain and clean. The Bending Sensor is a variable resistor that changes as it is bent. The 
sensor is a 9-axis movement and position sensor that consists of 3 acceleration channels, 3 
angular rate channels, and 3 magnetic field channels that measure wrist movements. They are 
connected to a computer system which can accurately compute the amount of individual finger 
movements. The available games provide various kinds of motion tasks such as ADL-related 
tasks presented in an entertaining manner. The learning schedule algorithm automatically 
adjusts to the optimal level of difficulty to balance challenge and motivation. 
 
 
 
Fig 2: The Smart Glove 
Fig 3: Using the Smart Glove in the VR 
environment 
 
Risks 
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Benefits 
The participant may experience improvement in the function of their affected upper extremity. 
 
Withdrawal 
Each subject, the sponsor or its designee, and the investigator reserve the right at any time to 
terminate a subject’s participation in the clinical investigation.  
Possible reasons for study withdrawal:  
1) Subject voluntarily withdraws consent 
2) Subject develops an adverse event that would not allow him or her to continue in the 
study 

3) Subject has an adverse event which in the opinion of the investigator warrants 
withdrawal from the study. The sponsor or its designee must be notified within 2 
business days 
4) A decision is made by the subject and/or investigator that the subject should be 
withdrawn from the study 
 
Alternative to Participation: 
There are several alternatives to participation that each potential study candidate should 
discuss with their physician. The alternatives including not participating and seeking no other 
treatment, or not participating and seeking a standard-practice treatment which is outpatient 
occupational therapy. Additionally, however, candidates should understand that choosing to 
participate is not mutually exclusive with receiving outpatient occupational therapy. 
 
Data Collection, Transfer, and Storage 
Clinical data: We will complete a stroke log that documents all patients who are treated with 
the Smart Glove. For patients who are considered but not enrolled in this trial, the reason for 
exclusion will be recorded. The data collection process will entail site staff completing case 
report forms (CRFs) for the initial capture of research data during patient encounters, and the 
data will be entered into a secure Stanford Redcap database. Clinical data obtained on the case 
report forms will include patient demographics, previous medical conditions, MMT, FM, JTT, 
and SIS scores.  
 
References: 
1) Etoom et al. Int J Rehab Res. 2016. 
2) Laver et al,. Coch Data Syst Rev. 2 (2015) 
3) Mehrholz et al., Coch Data Syst Rev. 11 (2015) 
4) Nakayama et al. Arch Phys Med. 75, 394-8 (1994) 
5) Sathian et al., Neurorehab Neural Rep. 25, 21S-32S (2011) 
6) Shin et al., J Neuroengineer and Rehab. 13 (2016)  
7) Van der Lee et al., Stroke. 30, 2369-75 (1999)