TheraBracelet Phase I Small Business Technology Transfer Research (STTR) - The 1st and Only Wearable to Instantly Improve Hand Function
Phase: NA
Conditions: Hand Function, Stroke, Upper Extremity, Hemiparesis, Cerebrovascular Accident, Stroke Rehabilitation
Sponsor: TheraBracelet, Inc.

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COVER PAGE 
 
 
PROTOCOL TITLE: 
TheraBracelet: The first and only wearable to instantly improve stroke hand function 
PRINCIPAL INVESTIGATOR: 
 
Na Jin Seo, PhD  
 
NCT03318341 
 
 

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1.0 
Objectives / Specific Aims 
• 
Objectives: To determine the feasibility and safety of using this assistive device, 
TheraBracelet, every day during waking hours, and to determine if TheraBracelet’s 
instant effects are sustained during prolonged use. 
• 
Design: Community-dwelling chronic stroke survivors will be randomly assigned to 
either the treatment or control condition for the first month, followed by a 2-week 
washout period and then crossover to the other condition. In both the treatment and 
control conditions, participants will be instructed to wear the device for at least 8 
hours/day every day during their normal daily activity and come to the laboratory for 
evaluation prior to and each week of using the device (for a total of 5 evaluations 
over 4 weeks). The device will deliver vibration (treatment) or no vibration (control). 
Double- blinding will be possible because the treatment vibration is imperceptible 
(i.e., subthreshold). 
• 
Primary Aim: Determine the feasibility and safety of using TheraBracelet daily for a 
month. For feasibility, compliance in using the device will be assessed by weekly 
self-reports of usage. Hypothesis: TheraBracelet will have a feasibility level 
comparable to wearing a non-vibrating wristband. To determine safety, participants 
will be examined at each weekly visit for any worsening of hand sensation, dexterity, 
grip strength, upper limb pain, spasticity, and wrist skin irritation. Adverse events 
will be recorded and categorized by severity (minor, moderate, and serious) and 
device relevance (related to device use or not). Adverse event frequency will be 
compared between conditions, and with a comparable FDA-approved device, 
Bioness electrical muscle stimulator. Hypothesis: TheraBracelet will have a safety 
level equivalent to or better than the comparable FDA-approved assistive device. 
• 
Secondary Aim: Determine the durability of TheraBracelet’s instant effect over a 
month. TheraBracelet’s instant effects will be quantified as an increase in the hand 
touch sensation score, dexterity score, and grip strength with vibration turned on vs. 
off (with ‘on’ and ‘off’ tested in a random order) in each weekly evaluation. 
Hypothesis: TheraBracelet’s instant effects in improving hand function will persist 
across all weekly evaluations (i.e. desensitization to vibration will not occur during 
extended daily use over a one-month period). In addition, the broader impact of 
TheraBracelet will be assessed by comparing self-reported abilities for activities of 
daily living and quality of life between the treatment and control conditions. 
2.0 
Background 
Stroke is a leading cause of long-term disability in the U.S. More than two thirds of nearly 
7 million stroke survivors in the U.S. have persistent hand impairment. This treatment-
resistant hand impairment diminishes stroke survivors’ abilities for activities of daily living 
including self-care, hygiene, and employment, which lowers their independence and 
burdens caregivers. The total cost of stroke from 2005 to 2050 is projected to be $2.2 
trillion, with $13 billion annually in indirect costs associated with lost wages. 
Unfortunately, with the rehabilitation service reimbursement cap, most stroke survivors 
live with persistent hand impairment for the rest of their lives, with no therapy. Existing 
devices are impractical for daily home use. The proposed technology aims to fill this gap 
by providing an assistive device, TheraBracelet, that enhances stroke survivors’ hand 
sensation and dexterity throughout daily living. Our preliminary studies with this vibrating 

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wristband have shown to instantly improve chronic stroke survivors’ touch sensation as 
well as hand dexterity (Enders et al. 2013; Seo et al. 2014).  However, additional research 
is needed to evaluate the feasibility and safety of TheraBracelet over longer periods of time 
(e.g. one month) as well as durability of its instant effect. Public health implication is that 
by improving stroke survivors’ abilities for activities of daily living, TheraBracelet intends 
to increase functional independence and lessen caregiver burdens, which will contribute to 
increased rates of return to work and productive lifestyle for both stroke survivors and 
caregivers.  
3.0 
Intervention to be studied  
Device: A stand-alone prototype is composed of an MP3-playing watch and a vibrator (see 
the pictures below; total weight 40g, watch=3.7cm×5.3cm). Both items are off-the-shelf 
products (i.e. available to purchase for anyone). The vibrator is attached to the wristband of 
the watch. The vibrator’s wire is connected to the MP3 player via an audio jack. The MP3 
player drives the vibrator with its internal battery for at least 22 hours, enabling a full day 
of use after an overnight charge. The MP3 player/watch is charged using a conventional 
phone charger. The MP3 player can play any file including the treatment vibration file with 
white noise vibratory signal at the intensity that is 40% below the sensory threshold (i.e. 
subthreshold, imperceptible to the participant) and control file with zero amplitude (i.e. no 
vibration).  
           
 
 
FDA: The use of the vibrator for this proposed purpose of affecting the hand sensation 
and/or dexterity has not been approved by the FDA. The vibrator is a general-purpose 
vibrator, not specifically designed for any particular purpose. Safety of using this vibrator 
at the proposed intensity (40% below the person’s sensory threshold, i.e. imperceptible) for 
a month has not been studied, and will be studied as a primary aim of the proposed 
research. Currently there is no vibration exposure guideline for this small level of 
vibration. People are exposed to higher-intensity, suprathreshold vibration daily (e.g. from 
a phone, riding a car).  
Control/placebo: No vibration will be the control condition. The MP3 player will play a 
zero-amplitude file, producing no vibration.   
 
4.0 
Inclusion and Exclusion Criteria/ Study Population 
Inclusion Criteria  
• 
Age = 18 or older 
• 
Time since stroke>3 months  
• 
Those with at least some movement in the affected upper limb (The Fugl-
Meyer upper limb score is expected to be approximately 20 or higher) 
• 
Able to put on the device at home 
• 
Ability to perform the Box and Block Test with a score greater that zero 

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Exclusion Criteria 
• 
Comorbidity such as peripheral neuropathy, orthopaedic conditions in the hand  
• 
Compromised skin integrity of the hand/wrist due to long-term use of blood 
thinners, scars on the hand/wrist from burn or other injury  
• 
Participation in an upper limb rehabilitation program concurrently  
• 
Pregnancy, since swelling is common in pregnancy 
• 
Those whose swelling changes dramatically during the day, which would 
require constant adjustment of the wristband tightness 
• 
Participant has received Botulinum toxin injection in the past 3 months 
• 
A language barrier or cognitive impairment that precludes following 
instructions  
• 
Inability or unwillingness of subject or legal guardian/representative to give 
informed consent 
• Screening: Eligibility will be determined based on the potential participant’s verbal 
disclosure.  
• Exclusion of children: Children will not be recruited since stroke is rare in children.  
5.0 
Number of Subjects 
The enrollment goal is 24 subjects at the time of randomization. Considering potential 
ineligibility after enrollment, a total of 30 recruitment is proposed.  
6.0 
Setting 
Research Laboratory  
Study Sites  
College of Health Professions Research Building, 77 President Street, Charleston SC 
 
7.0 
Recruitment Methods 
This study will recruit from the Registry for Stroke Recovery (RESTORE-Pro#00037803, 
IRB approved9/6/14) which is a research tool sponsored by the National Institutes of 
Health (NIH) Center of Biomedical Research Excellence (COBRE) in Stroke Recovery 
with subjects consented for future contact to support stroke recovery research conducted at 
MUSC.  RESTORE staff will query the registry for potential subjects and provide the 
Principal Investigator (PI) with the contact information of subjects who meet their criteria.  
The PI or research staff will contact subjects to further screen for potential enrollment. 
 
8.0 
Consent Process 
Informed consent will be obtained from the participant. The consent process will take place 
when the potential participant comes to the laboratory on a scheduled time agreed upon 
between the study personnel and the participant. In a private room, the content of the 
consent will be verbally explained to the participant and the participant will be asked to 
raise any questions and concerns. If the person requests a waiting period, then one will be 

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given. If the person desires to consent immediately, then the person will provide consent 
immediately.  
9.0 
Study Design / Methods 
• 
Study design: The study will use a 2×2 crossover design. Participants will be 
randomly assigned to either the treatment or control condition for the first month, 
followed by a 2-week washout period and then crossover to the other condition. For 
both conditions, participants will be instructed to wear TheraBracelet on the affected 
wrist every day for at least 8 hours/day during their daily activity over a month. The 
device will apply wrist vibration at 60% of the sensory threshold (imperceptible) for 
the treatment condition, and no vibration for the control condition. The control 
condition is needed to assess safety of TheraBracelet in comparison to that of simply 
wearing a wristband, thereby accounting for any worsening of symptoms that may 
occur as a natural course after stroke. Half the participants will start with the 
treatment and half with the control (balanced).  
• 
Schedule: One person’s participation will be 2.5 month long (= 1 month for one 
condition, 2 week washout period, 1 month for another condition). For each 
condition, participants will come to the laboratory once a week for evaluation for a 
total of 5 times: The 1st visit will entail the baseline evaluation followed by an 
introduction to using the device. Subsequent visits will be for evaluation after using 
the device each week. A follow-up assessment will be administered 4-16 weeks after 
the 10th session if any safety measure has worsened as defined as an adverse event 
by the 10th visit compared to the 1st visit. The follow-up assessment will evaluate 
only the measure that has worsened.  
• 
Evaluation will include feasibility, safety, and durability, as detailed below. 
• 
Feasibility: We will compare user compliance in using the device in the treatment vs. 
control. Compliance will be assessed using self-reports. Participants will bring home 
a device usage log, record time at which they put on and take off the device every 
day, and submit the log during the weekly evaluation. Study personnel will record 
which hand the participant is wearing the device (right vs left) at the beginning of the 
weekly evaluation session. During their final session, participants will complete a 
technology acceptance questionnaire to evaluate their experience using the device. 
Additionally, a pedometer function will be run in the watch to obtain a total number 
of steps for a week, which can provide a rough estimate of the wear time. Participants 
will also wear the device while completing a 10-meter walk test during their initial 
visit. Walking speed and the pedometer reading will be recorded when the test is 
complete.  
• 
Safety: We will compare the rate of occurrence of adverse events in the treatment vs. 
control condition. The measures of adverse events will include worsening of hand 
sensation, hand strength, hand dexterity, upper limb pain level, spasticity, and wrist 
skin irritation. Specifically, hand sensation will be assessed using the Monofilament 
Test, the Two-Point Discrimination Test, and verbal report of any numbness and 
tingling. Hand sensation will be determined to have deteriorated if any of these hand 
sensation test results declines by a category (e.g. “normal” to “diminished light 
touch” for the Monofilament Test with a change more than two points; “no” to “yes” 
for numbness and tingling). Hand strength will be determined to have deteriorated if 
grip strength declines by more than 20% from the baseline (which is approximately 2 
standard deviation of the population grip strength data) and more than minimal 

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detectable change (MDC) (also known as the smallest real difference, Chen et al 
2009). Hand dexterity will be determined to have deteriorated if the Nine Hole Peg or 
Box and Block Test score worsens by more than 20% (approximately 2 standard 
deviation of the population data) and MDC (Chen et al 2009). Hand strength and 
dexterity measurement will be performed three times during the baseline testing. 
Upper limb pain will be assessed using the visual analog pain rating scale (0 to 10). 
Upper limb pain will be determined to have increased if the pain level indicated on 
the visual analog pain rating scale increases by more than 2. Spasticity will be show 
assessed using the Modified Ashworth Scale (MAS). Spasticity will be determined to 
have worsened if MAS increases by more than 1 point (equivalent to the effect size 
of botulinum toxin A). Wrist skin irritation and increased swelling, if there is any, 
will be noted. Rigorous safety criteria will be used in which adverse events will be 
noted if any of the measures (hand sensation, strength, dexterity, pain, spasticity, skin 
irritation, swelling) worsens at any of the four evaluation times compared to the 
baseline. The co-investigator and study neurologist, Dr. Wayne Feng, will meet with 
each participant in person or via teleconference to interview the participant regarding 
safety related to wearing the device. 
• 
Durability: The durability of TheraBracelet’s instant effect will be examined by 
assessing TheraBracelet’s instant effect in each weekly evaluation and comparing 
them across. The instant effect will be quantified as increase in the hand touch 
sensation (Monofilament Test) dexterity scores (Nine Hole Peg and Box and Block 
Tests) with vibration turned on compared to off, with the ‘on’ and ‘off’ tested in a 
random order, blinded, within a single evaluation session. If TheraBracelet’s instant 
effect is seen for all evaluation times, it will support durability (i.e. desensitization to 
vibration does not occur). In addition, the impact of TheraBracelet on stroke 
survivors’ self-reported abilities for activities of daily living and quality of life will 
be assessed. Specifically, the Stroke Impact Scale, SIS (sections of the hand, 
activities of daily living, and recovery), and Stroke Specific Quality of Life, SS-QoL 
(sections of the self-care and upper extremity function), will be obtained at weekly 
evaluations and compared between the two conditions. The Nine Hole Peg and Box 
and Block Tests will be videoed to ensure the exact start and stop time are recorded. 
This video will not include the participant’s face in order to maintain confidentiality.  
• 
Protection against risk: For fatigue, frequent sufficient breaks will be provided to 
participants. As for potential skin irritation due to wearing the wristband, the 
wristband tightness may be adjusted with a new wristband to maximize participant 
comfort. Participants will be notified if we learn anything that might make them 
change their mind about participating in the study. Potential risks of deterioration of 
hand sensation, strength, and dexterity, increased upper limb pain level and spasticity 
level, and/or wrist skin irritation will be monitored every week during the weekly 
evaluation when participants come to the laboratory. In fact, these events are the 
outcome measures of safety for the primary aim of the study. Participants will be 
informed that they can drop out of the study any time without penalty.  
10.0 Data Management  
• 
Confidentiality protection: The data from test results will be de-identified once it has 
been collected and before it is stored.  This means individual results would not be 
able to be linked to the participant by others who review the results of this research. 
The linkage between participant codes and identities as well as all other identifiable 

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information including consent forms will be stored in a locked room and be 
accessible only to the study personnel. 
• 
Statistical analysis: For Primary Aim of feasibility and safety, we will compare rates 
of compliance and device-related adverse events between the treatment and control 
conditions using the test of non-inferiority. For safety, we will analyze the data using 
the “intent to treat” paradigm. The meaningful difference in adverse events to detect 
between the treatment and control is 20% for the following reason. For a regulatory 
approval, a safety level similar to a comparable FDA-approved device is desired. One 
such device, with availability of safety data, is a Bioness electrical stimulator for foot 
drop: It has a 21% higher likelihood for adverse events compared to a standard ankle 
foot orthosis (Kluding et al. 2013). Based on power analysis below, we will be 
sufficiently powered to statistically discern different rates of adverse events if more 
than 3 out of 24 participants experience adverse events in the treatment vs. control 
condition. In other words, if 3 or less participants out of 24 experience adverse events 
in the treatment vs. control condition, we will deem TheraBracelet safe for the 
purpose of an FDA approval. We will verify that there is no order effect using exact 
binomial tests. 
• 
For feasibility, compliance will be defined as participants’ use of the device for at 
least half the prescribed time. The reason is that 4 hours/day is still a substantial use 
of this assistive device in daily living, and will provide sufficiently useful 
information about feasibility of TheraBracelet. Similarly with the analysis for safety, 
if 3 or less participants out of 24 are incompliant in the treatment vs. control, we will 
conclude that TheraBracelet is as feasible as wearing a non-vibrating wristband. The 
cumulative hours of device usage will also be examined for both conditions to inform 
the general usage trend. 
• 
For the secondary outcome of durability of TheraBracelet’s instant effect, the 
hypothesis will be tested using repeated measures ANOVA for each hand function 
measure, with factors of vibration (on/off), condition (treatment/control), evaluation 
time (1-5), and their interactions. A significant main effect of vibration, with 
improved hand function with vibration on vs. off, with non-significant interactions of 
vibration×evaluation time and vibration×condition, would indicate durability over a 
month. In contrast, a lesser extent or abolishment of the instant effect toward the later 
evaluations or for the treatment condition, with significant interactions of 
vibration×evaluation time or vibration×condition, would indicate desensitization. In 
that case, the time point at which the instant effect wanes will be examined using 
Tukey type posthoc pairwise comparisons.  
• 
A possibility exists that instant enhancement of hand function with TheraBracelet 
may trigger more use of the affected hand in daily living, which, when accumulated 
over time, might lead to improvement of the innate hand function (without vibration). 
This is analogous to cane users who may walk more with canes than without, and 
thus build greater lower limb abilities over time. Thus, change in the innate hand 
function will be examined. A significant effect of condition×evaluation time, with 
greater improvement of the innate hand function for the treatment vs. control, will 
suggest a therapeutic effect of TheraBracelet for secondary investigation.  
• 
Impact of TheraBracelet on activities of daily living and quality of life will be 
assessed using repeated measures ANOVA for the SIS and SS-QoL, with the main 
effect of condition.  

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• 
Power analysis: The sample size for the primary outcome of safety was determined 
for testing hypothesis of non-inferiority using a 2×2 crossover at 80% power and 5% 
significance level. A sample size of 24 (12 in each condition at randomization) 
provides sufficient power to conclude non-inferiority within a difference in adverse 
events of 20% between the discordant pairs (those who are safe with control but 
unsafe with treatment vs. those with the opposite), assuming a total of 10% 
discordance rate (proportion of participants with different responses for the two 
conditions) and a 90% safe rate for the control. That is, we will be powered to 
statistically conclude non-inferiority (hence safety) if 3 or less out of 24 participants 
have adverse events in treatment vs. control. For the Secondary Aim involving 
repeated measures ANOVA, with the effect size of f=0.25 for the Box and Block 
from our previous study,(Seo et al., 2014) a sample size of 19 is needed assuming a 
conservative correlation of 0.3 across evaluation times, for 80% power and 5% 
significance level. Thus, we will aim to obtain data from 24 participants. Considering 
that some may be found ineligible after enrollment, a total of 30 recruitment is 
proposed.  
• 
Data sharing: Only de-identified coded data will be reported and/or shared with the 
public in publications, in ClinicalTrials.gov, or upon written request.  
11.0 Provisions to Monitor the Data to Ensure the Safety of Subjects  
• 
Data and Safety Monitoring Board (DSMB): The primary purpose of the DSMB is to 
ensure the safety of participants and the validity and integrity of data collected during 
the study. By having the DSMB, safety concerns will be addressed objectively, in a 
timely manner. If the intervention definitively has safety concerns, the DSMB may 
recommend stopping the study early.  
• 
The DSMB will be composed of (1) a board certified physician with expertise in 
stroke management, (2) a registered and licensed occupational therapist with 
expertise in stroke rehabilitation, and (3) a biostatistician with expertise in design and 
analysis of clinical trials. 
• 
The responsibilities of the DSMB are as follows. Prior to any enrollment, the DSMB 
will review the study design, protocol, recruitment/enrollment plan, statistical 
analysis plan, and data safety monitoring plan, and document the agreement or 
recommendation. Once the enrollment begins, the DSMB will convene every 3 
months to review the safety data (i.e. worsening of hand sensation, hand strength, 
hand dexterity, upper limb pain level, upper extremity spasticity, and wrist skin 
irritation, and any other adverse events regardless of whether it is related to the 
device use or not) as well as the enrollment data including any discontinuation of 
participation in the study with or without adverse events, new enrollments, and 
progression of the enrollees’ participation in the study. The DSMB will review the 
aggregated summary data as well as the individual participants’ data (de-identified). 
The DSMB will provide recommendations for any adverse events and safety 
concerns. The DSMB will also provide a report to the IRB to summarize oversight 
activities, recommendations, and any concerns regarding participant safety.   
• 
The DSMB will have access to coded (de-identified) data but not identifiable data. 
While the experimenters and participants are double-blinded to the condition 
assignment information during the study progression, the DSMB will have access to 
the condition assignment information during the study progression in order to assess 

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the safety of the TheraBracelet vibration in comparison to that of simply wearing a 
wristband (i.e. control) and separately assess other safety issues such as assessments.  
• 
Reporting of safety data: All safety data including adverse events will be reported to 
the DSMB, IRB, and relevant funding agencies. Summative safety data will be 
reported in ClinicalTrials.gov and in publications. Following the guidelines, we will 
register this study in ClinicalTrials.gov as soon as the study commences (at the latest 
within 21 days after the first participant is enrolled) and report results including all 
adverse events as soon as the study is completed (at the latest within12 months of the 
trial’s primary completion date). To protect participants’ confidentiality, personally 
identifiable information will not be used for reporting. Only de-identified or 
aggregated data will be used for reporting. 
• 
Endpoint: Participants will be assured of their right to discontinue their participation 
in the study at any time. In addition, the study physician, Dr. Feng, may recommend 
discontinuation of participation if his/her adverse event is deemed to warrant 
discontinuation, without breaking the double-blinding. However, the condition 
assignment information will be available to the DSMB to make appropriate judgment 
during the study progression.  
12.0 Risks to Subjects 
There is a slight risk for loss of confidentiality. There is a minor risk of physical and 
mental fatigue from engaging in the study activity. The treatment a person receives at 
one time point may be less beneficial than the other study treatment. There is a minor 
risk of skin irritation from wearing the wristband and/or from vibration. There is a 
minor risk of discomfort in moving the arm/hand due to the weight of the device on the 
wrist, although the device weighs only 40g. Potential risks that may be associated with 
use of wrist vibration all day every day for a month will be tested as the primary 
outcome measures of safety within the study. These risks are: deterioration of hand 
sensation, strength, and dexterity, increased upper limb pain level, spasticity level, 
and/or wrist skin irritation. Occurrence of these adverse events are expected to be rare 
because the intensity of vibration used in TheraBracelet is subliminal while we are 
exposed to higher-intensity, suprathreshold vibration daily (e.g. from a phone). 
TheraBracelet has also been used during hand task practices in chronic stroke survivors 
for a total of 6 hours over 2 weeks without reportable adverse events in the PI’s current 
study. However, there has not been a study that focuses on safety of TheraBracelet. 
Currently there is no known information regarding any side effects associated with 
using this small imperceptible (unfelt) level of vibration all day every day for a month. 
Currently there is no vibration exposure guideline for this small level of vibration.  
13.0 Potential Benefits to Subjects or Others 
There may be no benefit from participating in this study. The potential benefit is that 
the vibration the person receives may help their hand function in daily living, although 
this cannot be guaranteed. The vibration the person receives may increase their innate 
hand function (without vibration) over time (assessed as secondary investigation under 
Secondary Aim), although this cannot be guaranteed. The knowledge regarding the 
potential of using unperceivable vibration as a daily assistive or therapeutic option is 
important to increase quality of life of people who had a stroke and may benefit stroke 
survivors in general. The risks are deemed reasonable in relation to the potential gain 
of knowledge regarding this technology’s feasibility, safety, and efficacy in potentially 
enhancing hand function and quality of life.  

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14.0 
Sharing of Data  
The RESTORE registry (Pro#00037803), from which this study may recruit subjects, 
also serves as a data analysis tool by which interdisciplinary teams may share data 
across projects and provide MUSC’s stroke recovery research community with a more 
complete registry with key stroke elements.   Some subjects may have participated or 
will participate in other stroke related research studies at MUSC.  Sharing data from 
this and other stroke research studies with RESTORE will allow for more targeted 
recruitment efforts in the future and could reduce the burden placed on subjects by 
reducing the duplicative efforts of collecting common data and physical function 
assessments requested by multiple studies and storing them in one centralized and 
secure location.  
Subjects are informed in the consent process if they enroll into the RESTORE registry, 
their data from this study will be shared.  Those who have participated in other stroke 
research will be asked to sign a Release of Study Records form to share data with 
RESTORE if they did not already authorize release.  Subjects will be asked to sign a 
HIPAA authorization stating their health information may be disclosed to MUSC 
investigators requiring their data for their research projects upon approval by an 
Institutional Review Board. 
15.0 Devices  
The vibrators and watches will be stored in the laboratory and will be provided to the 
participants by the study personnel. The participants will use the device at home by 
themselves, and return the device to the study personnel when the 1-month period is 
completed. The device does not have an IDE.  
References 
 
Chen H-M, Chen CC, Hsueh I-Pk, Huang S-L, Hsieh C-L (2009) Test-Retest Reproducibility and 
Smallest Real Difference of 5 Hand Function Tests in Patients With Stroke. Neurorehabil Neural Repair 
23(5):435-440. 
 
Enders LR, Hur P, Johnson MJ, Seo NJ (2013) Remote vibrotactile noise improves light touch sensation 
in stroke survivors' fingertips via stochastic resonance. J Neuroeng Rehabil 10:105. 
 
Kluding PM, Dunning K, O'Dell MW, Wu SS, Ginosian J, Feld J, McBride K (2013) Foot drop 
stimulation versus ankle foot orthosis after stroke: 30-week outcomes. Stroke 44:1660-1669. 
 
Seo NJ, Kosmopoulos ML, Enders LR, Hur P (2014) Effect of Remote Sensory Noise on Hand Function 
Post Stroke. Front Hum Neurosci 8:934.