Sensory Stimulation During Constraint-Induced Movement Therapy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Medical University of South Carolina

 
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COVER PAGE 
 
 
Study Title: Sensory Stimulation during Constraint-Induced Movement Therapy 
 
NCT03558230 
Version Date: 07/24/2018 
IRB Approval Date: 7/30/2018 
 
 

 
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PROTOCOL TITLE: Sensory Stimulation during Constraint-Induced Movement Therapy  
 
PRINCIPAL INVESTIGATOR: Na Jin Seo, PhD 
 
1.0 Objectives / Specific Aims  
 
The objective of this pilot project is to assess the impact of the novel sensory vibration 
stimulation technique we have developed, named TheraBracelet, in enhancing outcomes of 
constraint-induced movement therapy (CIMT) in children with cerebral palsy (CP). 
TheraBracelet is peripheral sensory stimulation involving application of low-level 
(imperceptible), random-frequency vibration to the wrist skin. The hypothesis is that 
improvement in upper extremity function will be greater for the experimental group receiving the 
TheraBracelet stimulation during CIMT compared with the control group who will wear the 
device with no vibration (placebo). 
  
2.0 Background  
 
Pediatric CIMT is one of the most effective treatment approaches for children with unilateral 
motor weakness or hemiparesis, regardless of the neuromotor impairment’s etiology (Ramey et 
al. 2013). CIMT involves applying a hand splint and mitt on the stronger, unaffected upper 
extremity a hand splint and mitt on the stronger upper extremity to encourage use of the affected 
upper limb in intensive therapy.  Research evidence supports the use of intensive therapy models, 
such as CIMT, to improve overall function in adults and children with one-sided motor weakness 
or a hemiparesis (Taub et al. 2007 & 2004, Eliasson et al. 2005, Brady and Garcia 2009, Case-
Smith et al. 2012, Huang et al. 2009, Coker et al. 2009, DeLuca et al. 2003, 2007, 2012a,b, 
Nelles 2004, Sakzewski et al. 2009, Al-Oraibi and Eliasson 2011, Barry  2001, Bower and 
McClellan 2004).  
 
Patty Coker-Bolt, PhD, OTR, FAOTA co-developed and currently hold a yearly one-week 
modified pediatric CIMT camp at MUSC which has provided an intensive CIMT therapy 
program for over 200 children (approximately 3 to 9 years of age) with hemiplegic CP since 
2001 and is an ongoing annual effort. The camp provides a hands-on on learning opportunity for 
occupational and physical therapy students who serve as camp counselors under the mentorship 
of licensed therapists. The intensive group-based day camp program is now embedded into the 
occupational and physical therapy course curriculum and a systematic course with training 
modules has been developed to teach students how to provide the essential components of 
pediatric CIMT. The children that have participated in this intensive 30 hour CIMT program 
have demonstrated significant improvements in overall self-care, upper extremity function and 
mobility skills (Coker et al 2010, Ramey et al 2013).   
 
3.0 Intervention to be studied  
 
TheraBracelet stimulation entails application of low-level, random-frequency vibration to the 
wrist skin, to affect the cortical sensorimotor activity during concurrent upper extremity 
activities, with an intent to increase outcomes of therapy. Unlike existing methods including 
transcutaneous electrical nerve stimulation, muscle/tendon vibration, and repetitive transcranial 

 
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magnetic stimulation that require prior exposure to the sensory stimulation as long as 2 hours 
before each therapy session, TheraBracelet can immediately and continuously prime the central 
sensorimotor system based on preliminary data using neuroimaging (in preparation), and 
enhance hand motor scores (as measured by the Box and Block and Nine Hole Peg Tests) (Seo et 
al. 2014) and finger sensory scores (as measured by the Semmes-Weinstein Monofilament Test) 
(Enders et al. 2013) in adult stroke survivors while TheraBracelet was on. TheraBracelet 
stimulation is given to the wrist so that the entire hand is exposed to receive relevant sensory 
information and appropriately manipulate objects. Wearable wrist devices with a vibrating 
function are low cost and can be easily adopted for rehabilitation purposes to impact a wide 
range of patients with sensorimotor impairment. TheraBracelet has been used concurrently 
during 2-week therapy in adults with stroke and resulted in significantly greater improvement in 
the hand dexterity score compared to dose-matched therapy with no TheraBracelet, in the PI’s 
previous study (in review). 
 
Device: TheraBracelet stimulation is provided by a vibrator connected to an MP3-playing watch 
via an audio jack (see the pictures below; total weight 40g, watch=3.7cm×5.3cm). No external 
power source is needed, since the MP3 player drives the vibrator with its internal battery. Both 
the vibrator and watch are off-the-shelf products (i.e. available to purchase for anyone). 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 and control file with 
zero amplitude (i.e. no vibration). The treatment vibration will be scaled to a level that is 40% 
below the sensory threshold for healthy adults without neurologic disorders, neuropathy, or 
compromised skin (i.e., the treatment vibration is imperceptible to healthy adults). The rationale 
for the subthreshold intensity is that our previous studies with TheraBracelet showed that this 
level of imperceptible vibration intensity improved finger sensation more than suprathreshold 
(i.e., perceptible) vibration in healthy adults as well as adult stroke survivors. Adults’ sensory 
threshold will be used, as children could not reliably respond regarding their perception of barely 
noticeable or unnoticeable vibration.  
 
 
     
 
FDA: The use of the vibrator for this proposed purpose of affecting the cortical sensorimotor 
activity during therapy with an intent to increase therapy outcomes has not been approved by the 
FDA. The vibrator is a general-purpose vibrator, not specifically designed for any particular 
purpose.  
 
Safety: Currently there is no vibration exposure guideline for this small level of vibration (at 
40% below the sensory threshold). People are exposed to higher-intensity, suprathreshold 

 
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vibration daily (e.g. from a phone, riding a car). Truck drivers who get exposed to whole-body 
vibration are limited to driving 11 hours after 10 consecutive hours off duty, according to Federal 
Motor Carrier Safety Administration. TheraBracelet has been used during 2-week therapy (2 
hours/session, 3 sessions/week for 2 weeks) in adults with stroke and resulted in significantly 
greater improvement in the hand dexterity score compared to dose-matched therapy with no 
TheraBracelet, without adverse events (i.e., no skin irritation, no numbness) in the PI’s previous 
study (in review). In the PI’s current study, TheraBracelet is being used all day (during waking 
hours), everyday, for a month, in adult stroke survivors, without a safety concern thus far. 
TheraBracelet has not been used in children, although high-level (i.e. perceivable) vibration has 
been used in children with CP to treat spasticity and motor function (Katusic et al. 2013).  
 
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  
 
Children will be between the ages of 3 and 9 year of age and have a unilateral upper limb motor 
weakness.  The child must use the affected extremity as a gross assist during play and self-care 
activities.  The children demonstrate no significant developmental delays that would limit 
spontaneous use of the more affected extremity. The children will be ambulatory for their age 
and demonstrate intact balance and protective reactions throughout the less involved upper 
extremity. The children will have no other health impairment other than hemiparesis. No 
inclusion or exclusion criteria will be based on race or gender.   
 
5.0 Number of Subjects  
 
Total Planned Enrollment: 20 
 
6.0 Setting  
 
Site: Laboratories of the College of Health Professions, 151A Rutledge Ave., Charleston SC 
The camp will be directed by Dr. Coker-Bolt who is a licensed occupational therapist and will be 
staffed with a physical therapist and camp counselors.  The camp counselors will be occupational 
and physical therapy students enrolled in programs at the Medical University of South Carolina.  
This will allow each camper to have 2-to-1 ratio of staff to child ratio with personnel that have 
experience working with children.   
 
7.0 Recruitment Methods  
 
Participants for this study will be recruited children who attend the yearly camp CIMT program. 
Parents/guardians of all children who will attend the CIMT program will be informed of the 
study. The CIMT is an ongoing yearly camp.  
 
8.0 Consent Process 
 

 
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Study personnel will obtain the informed consent of the parent, parent/guardian, or guardian of 
each child participating in the study. In a private setting, the content of the consent will be 
verbally explained and the parent/guardian will be asked to raise any questions and concerns. If 
the person requests a waiting period, then one will be 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 be a double-blinded stratified randomized controlled trial. 
Consented children will be stratified in terms of their functional levels (based on MACS). Within 
each functional level, children will be randomly assigned to either the experimental or control 
group, in a balanced manner (half the children assigned to one group, and the other half assigned 
to the other group). All consented children will receive CIMT 6 hours/day, 5 consecutive days 
for 1 week. This duration of CIMT resulted in significant improvement in capacity and quality of 
affected upper limb functioning (Coker et al 2010, Ramey et al 2013, Coker-Bolt et al 2017). All 
consented children will wear the TheraBracelet device during CIMT. The device will provide 
treatment vibration to the experimental group and no vibration to the control group.  
 
Blinding: A custom MATLAB program will perform group assignment and produce a treatment 
vibration or zero vibration file depending on the group assignment for each child. The produced 
vibration file will be uploaded to the TheraBracelet device for each child, and used throughout 
CIMT. The treatment vibration is imperceptible to healthy adults. Therefore, all personnel 
involved in CIMT will be blinded to the group assignment. It is anticipated that children who 
receive treatment vibration would not perceive the vibration from the TheraBracelet device. In an 
unanticipated case where a child indicates that s/he perceives vibration any time during CIMT, 
the vibration intensity will be lowered immediately.  
 
Pediatric CIMT protocol:  1) The soft mitt will be worn on the child’s stronger, less affected 
upper extremity during CIMT. 2) The child will be engaged fun, playful camp-based activities to 
encourage repetitive practice with the weaker limb and shaping of more mature motor responses 
while the mitt is being worn.  These play activities will be implemented by MUSC occupational 
and physical therapy students who are supervised by licensed therapists. 3) Tasks such as 
reaching, grasping, and manipulation of objects, weight-bearing, and making hand gestures with 
the weaker limb will be encouraged during play activities. 4) When the children demonstrate 
new motor movements, students and therapists will shape and guide the quality of these 
movements through participation in age appropriate activities. 
 
Outcome Measures: Experimental and control groups will be compared for post-therapy changes 
in the upper limb functioning. The upper limb functioning in daily living will be measured by 
standard pediatric therapy parent’s questionnaire assessments  before and after therapy. The 
quality and quantity of upper limb movements will be measured by the Quality of Upper 
Extremity Skills Test, and the Box and Block and Nine-Hole Peg Tests, respectively. 
Additionally, goal attainment scaling will be used to measure achievements of goals after CIMT. 
Lastly, we will measure the wear time of the device and the child pain level at each CIMT day. 
 

 
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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 information including consent forms will be 
stored in a locked room and be accessible only to the study personnel. 
 
Analysis: Repeated measures ANOVA with post hoc comparisons will be used to determine if 
each clinical hand function score improves more for the experimental compared with the control 
group. A significant interaction between time (pre/post) and group (experimental/control) will 
support the hypothesis that improvement of upper limb function will be greater with the low-
level vibration stimulation. 
 
Sample size determination: This is a pilot study using a convenience sample of children who will 
attend the summer CIMT camp program at MUSC. 
 
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 assessed and addressed objectively. If the intervention 
definitively has safety concerns, the DSMB may make recommendations to address the safety 
concerns.   
 
The DSMB will be composed of (1) a board certified physician with expertise in neurologic 
disorders, (2) a registered and licensed occupational therapist with expertise in rehabilitation, and 
(3) a biostatistician with expertise in design and analysis of clinical trials. 
 
The responsibilities of the DSMB are as follows. Prior to 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. After enrollment begins and 
the CIMT camp is provided, the DSMB will convene again to review the safety data, enrollment 
data including any discontinuation of participation in the study with or without adverse events, 
and study results. Safety data will include emergence of skin irritation, increase in muscle tone, 
reduction in the number of functional tasks completed by children, worsening in the quality of 
motor movements in children, and any other adverse events noted by camp counselors and/or 
licensed therapists, regardless of whether it is related to the device use or not.  The DSMB will 
review the aggregated summary data as well as the individual participants’ data (de-identified). 
The DSMB will have access to coded (de-identified) data but not identifiable data. The group 

 
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assignment information will become available upon completion of the data collection. The 
DSMB will provide recommendations for 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.   
 
Reporting: All safety data including adverse events will be reported to the DSMB and IRB. 
Summative 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 within 12 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, Dr. Coker-Bolt may recommend discontinuation of participation if 
his/her adverse event is deemed to warrant discontinuation, without breaking the double-
blinding.  
 
12.0Risks to Subjects  
 
• Confidentiality: There is a risk for loss of confidentiality.  
• Injury: There is a risk for injury during engagement in play activities involved in therapy 
interventions. Although therapy interventions used in the pediatric CIMT involve those play 
activities that a child would normally engage in during a typical day, children are at risk for 
injury during play and daily activities. There is a risk of physical and mental fatigue from 
engaging in the CIMT. 
• Mitt restraint: There is a risk of skin breakdown or irritation from the soft mitt restraint and 
stiffness in the less involved limb being constrained. The children could become frustrated or 
anxious from having their stronger hand restrained for several hours a day. 
• Randomization: The treatment a person receives may prove to be less effective or to have 
more side effects than the other study treatment or other available treatments.  
• Watch/Vibration: 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 prolonged use of wrist vibration, including irritation, muscle tones, reduction 
in the number of functional tasks completed by children, and worsening in the quality of 
motor movements in children will be noted during each day of CIMT, and formally assessed 
during pre/post assessments.  
• There is also a risk of unexpected medical emergencies.  
 
 
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 upper extremity functional recovery, although this 

 
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cannot be guaranteed. The knowledge regarding the potential of using low-level vibration as a 
therapy adjunct is important to increase functional recovery of children with CP and may benefit 
those with CP in general. The risks are deemed reasonable in relation to the potential gain of 
knowledge regarding TheraBracelet’s feasibility, safety, and efficacy in potentially enhancing 
upper extremity function.  
 
14.0 Sharing of Results with Subjects 
 
The results of the standardized tests will be shared with each child’s parent/guardian.  
 
15.0 Drugs or Devices  
 
The vibrators and watches will be stored in the laboratory and will be provided to the participants 
by the study personnel on each day of CIMT. The participants will use the device during CIMT 
and return the device to the study personnel when they leave CIMT each day. The device does 
not have an IDE 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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