Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity Function in Children With Cerebral Palsy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Virginia Commonwealth University

 
 
Title: Investigating the Effect of Stochastic Resonance Vibration on Gait and Balance and Upper Extremity 
Function in Children With Cerebral Palsy 
 
NCT #: NCT04388787 
 
Document date: 03/11/20 
 
Document Type: Protocol and SAP 
 
 
 

Investigating the effect of stochastic resonance on upper extremity function in 
children with cerebral palsy 
 
SPECIFIC AIMS 
 
Specific Aim: To determine effect of vibrotactile stochastic resonance (SR) on the speed and 
accuracy of manual reaching task in children with cerebral palsy. 
 
Hypothesis: SR will improve manual dexterity and improve performance on standardized outcome 
measures of upper extremity function. No carry-over effects (i.e. continued improvements after 
device use) are expected. 
 
BACKGROUND AND SIGNIFICANCE 
 
Impaired integration of proprioceptive signals may contribute to deficits in motor planning and 
poor postural control and balance in individuals with developmental disorders including cerebral 
palsy (CP)[1]–[4]. Conceptualizing movement as a sensory-motor process we hypothesized that 
disordered proprioception and sensory integration contribute to atypical movement patterns in 
persons with CP.  
 
Stochastic Resonance (SR) has been shown to enhance tactile sensory function[5], improve 
postural control[6] and enhance task performance in jumping activities[7]. In turn hypothesized 
that SR applied to extremities could facilitate functional movement in persons with CP.  
 
The term stochastic is used because the frequency varies randomly from moment to moment but 
averages approximately 100 Hz. The term resonance is used because the vibration is created by 
the dampening of a sound wave within the actuators.  This is essentially the same technology as 
is found in headphones. If you play music into your earphones and hold them in your fingertips 
you will feel the vibration. The 100Hz frequency is on the low end of the audible frequency range.  
When run at low amplitude it may be inaudible and undetectable to the touch sense. At higher 
amplitudes is felt as a light tingling vibration on the surface of the skin and makes a faint low 
pitched static noise. It is not painful and generally not bothersome.  
 
In the therapy centers and rehabilitation clinics of the Children’s Hospital of Richmond we have 
been using wearable wraps provided by Acclerainc that deliver SR via a piezoelectric actuator, to 
explore whether SR could have utility in supporting gait and upper extremity function. In several 
subjects SR, applied to the wrist and shoulder, was found to improve the ability of children to 
reach more quickly and accurately for objects and manipulate them to perform a desired task.  
 
In this proposal we plan to expand on our initial anecdotal observations of positive effect, in order 
to objectively quantify changes using validated measures of upper extremity function in children 
with CP treated with SR. We will use the box and blocks[8] and Shriners Upper Extremity 
Evaluation SHUEE [9]. Because CP encompasses a broad variety of movement impairments we 
will gather data on manual ability classification scale (MACS)[10]Test of Arm Selective Control 
and tactile sensory function to facilitate subgroup analysis [11].  
 
RESEARCH DESIGN AND METHODS 
 
A purposeful sample of 25 children with CP will be recruited to participate in the study. We will 
recruit children with no clinical complications that could interfere with their safe participation in all 

the experimental study procedures. All subjects will be screened by a member of the study staff 
with a clinical background. Screening will include a standard clinical history and a physical exam. 
 
Inclusion criteria 
To be eligible to participate in the study, individuals will have to meet the following criteria: 
• 
Diagnosed with cerebral palsy 
• 
3 years to 18 years of age 
• 
Able to reliably express pain, discomfort or fear as reported by the parent/guardian  
• 
Manual ability classification scale (MACS) levels I, II or III 
 
 
Exclusion criteria: 
Individuals will not be eligible to participate in the study if they exhibit any of the following: 
• 
Any unstable medical condition. An unstable medical condition is a state of imminent 
threat to life such as shock, acute asthma, respiratory distress, severe infection and 
sepsis. Any patient in a clinic or therapy center presenting with signs and symptoms of an 
unstable medical condition will be directed to emergency medical services 
• 
Any medical condition preventing active rehabilitation reported by the parent/guardian 
such as:  
o Thromboembolic disease, acute progressive neurological disorder, cardiovascular 
or pulmonary contraindications, aggressive behavior, severe cognitive deficits, 
joint instabilities and compromised bone health, recent or non-consolidated 
fractures, osteoporosis 
• 
Subjects with cardiac pacemakers, electronic pumps or any other implanted medical 
devices 
• 
Skin lesions affecting the areas where the device straps will be attached to the body 
 
 
DESCRIPTION OF THE STUDY PROCEDURES 
All study procedures will be carried out in rehabilitation clinics and participating therapy locations 
affiliated with Children’s Hospital of Richmond (CHOR) at Virginia Commonwealth University 
(VCU).  
 
 
RECRUITMENT PROCEDURES 
 
All study procedures will be carried out in participating therapy locations affiliated with Children’s 
Hospital of Richmond (CHOR) at Virginia Commonwealth University Health Systems (VCUHS) or 
at the physical medicine and rehabilitation clinics at the Children's Pavilion.   
All subjects will be recruited by IRB approved study staff for this protocol. Assent will be obtained 
from subjects who are enrolled by proxy consent. Recruitment strategies will include the use of 
the following sources: 
 
1. Attending physicians at CHOR-VCU may refer their patients with CP to the study. We will 
provide physicians with study information sheets and flyers. 
2. Study divulgation through the CHoR Pavilion pediatric clinic services in and CHOR-VCU 
therapy centers. 
3. Flyers posted in outpatient clinics, in pediatric neurosciences clinics and therapy. Study 
participants will receive up to $50 for completing the study. Additionally, for all subjects 

driving to the CHOR-VCU, parking is free, and easily accessible at all of the study 
locations. 
 
Recruitment will be ongoing for a 12-month period from the date that this protocol is accepted. 
Potential participants will be identified within the patient population presenting for care at clinics 
in the Children’s Hospital of Richmond, Children's Pavilion and from patients receiving treatment 
at any of the six collaborating Children's Hospital of Richmond therapy centers which receive 
referrals from numerous external pediatric providers in the central Virginia area. Flyers will be 
posted in the Children's Hospital therapy centers and the children's pavilion, so that patients, 
physicians and therapist will be aware of the study. 
Potential participants interested in the study may be screened enrolled directly by study staff 
members Jessica Lynn and Allison Wolf if they are present at the therapy location where a 
potential participant is identified, or will be able to request a screening through 1) Dr. Rolin’s office 
phone number 804-310-2644 2)They can directly email Dr. Rolin to request a telephone 
screening. 
Therapists at those locations will be briefed on the study and be able to refer appropriate 
participants to perform the study trials. If a potential study participant is receiving therapy services 
at a participating location, their diagnosis would be known to the referring therapist and 
determination of their manual ability classification is within the skill set of physical and 
occupational therapists. If present when a participant is identified Jessica Lynn (Bon Air therapy 
center) or Allison Wolf (Petersburg therapy center) will review the patient record to assure that 
the diagnosis of cerebral palsy has been stated in the clinical documentation by a qualified 
pediatric neurologist or physical medicine and rehabilitation specialist.  They will then screen the 
patient to ensure they meet the eligibility criteria. If the diagnosis of cerebral palsy is not explicitly 
stated in clinical documentation but is suspected by the study therapist, Dr. Rolin will access the 
medical record and determine whether the diagnosis is accurate.  
For participants that would be identified from the PM&R clinics, the process of screening fits into 
the normal flow of a clinic evaluation. When a patient presents to the PM&R clinic it is routine 
practice to establish the cause of a neurodevelopmental disability. The diagnosis of Cerebral 
Palsy is determined by the presence of abnormal tone and posture in an individual who sustained 
an injury to the developing brain in utero or up to three years of age. The cause of injury to the 
developing brain is confirmed in the interview with the family, and the review of for radiological 
and medical records. All persons with the diagnosis of Cerebral palsy ages 3 years to 18 years 
will be provided the opportunity to enroll in the study for aims. Assessment of test of selective arm 
control (TASC), modified ashworth scale (MAS), tactile sensory function and manual abilities 
classification scale (MACS) are part of standard clinical care.  
For participants referred by non-rehabilitation physicians, Screening will be performed by and Dr. 
Rolin by phone. Dr. Rolin will confirm the potential patient's parents identity by requesting they 
provide their child's name and date of birth. Dr. Rolin will ask questions about the patient's medical 
history and physical developmental history in order to determine if the patient meets the eligibility 
criteria for the study. Review of their medical records will be necessary to confirm eligibility.   
Individuals will be informed that if deemed eligible, identifiable information (e.g. name, how to 
contact the subject, and his/her address) will be collected.   

Participating locations include the following Children’s Hospital of Richmond at VCU therapy 
centers: 
Bon Air: 206 Twinridge Ln, Richmond, VA 23235 
Petersburg: 321 B Poplar Dr #4, Petersburg, VA 23805 
Children’s Pavilion, 1000 E. Broad Street, Richmond VA, 22918 
CONSENT PROCEDURES 
When subjects first contact the study team, a member of the study team will provide them with a 
detailed description of the study over the phone or in person. If interested and deemed potentially 
eligible, a member of the study team will offer to provide the informed consent form to the subject. 
Subjects will be encouraged to call study staff with any questions or concerns that might have 
prior to their first study visit. Upon arrival a study site, prospective study volunteers and their 
parents/guardians will be given another copy of the informed consent form and study staff will 
review the procedures with them and answer any questions they might have. 
When a patient presents for a scheduled study appointment, informed consent will be obtained 
by the Principal Investigator or a staff member designated by the Principal Investigator as 
adequately knowledgeable of the risks/benefits of the study and the vulnerability of the study 
population and capable to critically assess the subject’s awareness of these factors. The subject 
will be encouraged to continue to ask questions and express concerns - if any - to study staff 
throughout their participation in the study. At this point, the study procedures will be described 
and the equipment that will be used during the study will be shown to the subjects and their 
parents/guardians. Study staff will explain all the study procedures and the risks associated with 
them as outlined in the informed consent form (ICF) and assent form.  Enrollment will begin when 
the subject thoroughly understands and signs the informed consent form. Testing will only take 
place once the informed consent form is signed. 
 
TESTING PROCEDURES 
Subjects will be assessed in a single session in the participating therapy centers at the Children’s 
Hospital of Richmond or at the Children’s Pavilion. The visit will consist of the procedures 
described below and is expected to last 60-90 minutes. 
 
If not completed in the past 6 months during a clinical visit, the following clinical assessments will 
be performed prior to initiation of study trials: 
 
• 
Manual abilities classification score (MACS) 
• 
Modified Ashworth Scale (MAS) to evaluate the severity of spasticity at the shoulder, 
elbow, wrist and fingers. 
• 
Test of Arm Selective Control (TASC), focused on wrist and hand, to evaluate the severity 
of selective motor control impairment. 
• 
Assessment of tactile and kinesthetic sensation impairments by monofilament and two 
point discrimination testing. 
 
If the above listed clinical assessments were completed in the past 6 months, the data will be 
extracted from the participant’s medical chart. 
 
SR devices will be applied around the ventral and dorsal surface of the wrists as well as at the 
shoulder girdle on the tested (impaired) side. 
 

Stochastic resonance (SR) wraps will be applied to the one or both wrists depending on whether 
the impairment is unilateral or bilateral. Two additional actuators will be secured around the 
shoulder. Stochastic Resonance refers to the vibration created by the device.  
The threshold for detection of SR will be determined by the examiner prior to initiating the test 
condition. The intensity of the stimulation is adjustable with a scroll bar on the app and ranges 
from a 0 - 100. The examiner will gradually increase the stimulus intensity until the participant 
reports being able to feel it. The device will then be powered off. If for example the participant 
could feel the vibration at a level of 50 the device will be turned back on at 45 in order to provide 
stimulation at 90% of the detection threshold. Outcome measures will be assessed under the 
following conditions.  
1) Treatment: SR applied sub threshold at 90% of detection threshold.  
2) Sham: Patient wearing SR devices, but devices not turned on. Conditions 1&2 will be 
performed in random order, subject and examiner will be blinded to the condition. 
 
3) Unblinded: SR is applied above threshold for detection at a patient selected intensity. 
 
The following outcome measures will be assessed in each of the three different conditions 
described above. PDFs describing each test are attached separately. 
1. Box and block test (B&B)[8]  
2. Nine Hole Peg Test (9HPT)[12] 
3. Shriners Upper Extremity Evaluation (SHUEE)[9] 
 
During the visit, we will also collect video recordings while subjects perform the SHUEE. Video 
will be used for recording of the SHUEE and video recordings will be reviewed by an 
occupational therapy specialist blinded to the test conditions. It is worth emphasizing that, all 
subjects will be asked permission to be video recorded during the assessments as part of the 
consent process 
 
There will be no local changes to the protocol's procedures. Participants younger than 6 years 
of age, and older participants with poor behavioral regulation may not be able to complete all of 
the clinical assessments and outcome measurements. Elements of the study protocol can be 
omitted if a child cannot or is reluctant to complete them. We anticipate that all patients recruited 
will be able to complete at minimum the MACS, Modified Ashworth Scale and two iterations of 
the box and blocks test. The minimum test elements would take less than 15 minutes to 
complete.  
 
DATA ANALYSIS 
 
Comparison of performance under the baseline, sham, treatment and unblinded condition for 
B&B, 9HPT and SHUEE will be determined by paired T test. 
 
Subgroup analysis will be carried out by MACS level, TASC score and tactile sensory function.  
 
The above-described descriptive statistics will inform the design of a future larger trial aimed to 
assess the suitability of SR as a rehabilitation tool and assistive device. Results will be utilized do 
determine effect size and conduct a power analysis to power further studies.  
 
TREATMENT 
 
There will be no treatment administered as part of this study. Hence, there are no alternative 
treatments to be considered. 

 
RISKS 
 
Every precaution will be taken to ensure the safety of study participants. Risks will be minimized 
by screening subjects to identify potential safety concerns. Trained study staff will closely 
observe/guard participants during all study activities. All the activities to be performed during the 
study are comparable to activities that are carried out during regular therapy sessions. 
 
SAFETY 
 
We do not anticipate any greater than minimal risk from participation. At the beginning of each 
study visit, subjects will be examined by trained study staff to ensure their safe participation in all 
study activities. Subjects will be guarded by trained study staff at all times during the study. Any 
medical issues or adverse events will be reported promptly to Dr. Rolin, who will arrange for any 
necessary treatment. 
 
The clinical tests used in this study are standard instruments with minimal risks and will be 
administered by a study staff experienced in working with this patient population. Subjects will be 
asked to report all activity-related symptoms of pain or discomfort to the investigator, who will 
decide if medical care is warranted, and arrange for that care as appropriate. 
 
All laboratory equipment meets hospital standards for electrical safety. The SR devices used in 
this study are powered by low voltage batteries and are completely isolated from other electrical 
sources such as power lines. The device produces vibration with the same technology that is 
present in commercially available headphones.  They do not emit, heat, electrical current or 
substantial mechanical force that could cause injury.  
 
If necessary, study staff will make accommodations such as using multiple sessions to collect 
data, using voice amplifiers for participants who have hearing loss or auditory sensory 
impairments and providing live examples of how to perform tasks to facilitate participation. 
 
In the event of an AE or SAE, the study staff will remain in contact with the study participant until 
the problem has been resolved. 
 
All video recordings will be stored in a secure study share drive that will only be accessible by 
study staff. Study staff will use the video to score subjects’ SHUEE trials. Once the SHUEE exams 
have been scored the recordings will be destroyed. 
 
FORESEABLE RISKS AND DISCOMFORT 
 
When participating in the study, subjects will be at no greater risk of falls or injury than when 
seated in their home and community setting. 
 
Subjects may become fatigued or uncomfortable during the visit. To minimize fatigue, subjects 
will be allowed to rest whenever they need to, and they will always be monitored by study staff 
during the study. Subjects may become frustrated if performing study tasks with their impaired 
extremity is too challenging. Elements of clinical assessments and outcome measures can be 
omitted if a child cannot or is unable to or reluctant to complete them.  
Subjects may be uncomfortable due to the attachment of the SR device. If a child is made 
uncomfortable by the device, the study will be discontinued.  

 
Unintentional loss/disclosure of Protected Health Information may occur and is considered a 
minimal risk due to the security measures enforced at Virginia Commonwealth University Hospital 
System (VCUHS). Confidential information will be kept in a locked filing cabinet and password-
protected computers in the VCU-CHOR children’s pavilion. The subject will be video recorded, 
which increases the risk of identification, though precautions will be taken to secure such data. 
 
EXPECTED BENEFITS 
We do not expect that subjects will benefit directly from participating in the study. Through their 
participation, participants may help in gathering knowledge suitable to develop future 
rehabilitation interventions based in the use of SR to approve functional movement. Thus, the 
study might benefit people with CP in the future. 
 
EQUITABLE SELECTION OF SUBJECTS 
 
Subjects recruited in the study will be representative of the target population (i.e. children ages 3-
18 with cerebral palsy with gait or upper limb impairments). Due to the age of the study population, 
pregnant women are not likely to be eligible. No person will be excluded on the basis of gender, 
ethnicity, or race. Due to the relatively small budget of this pilot study, and because there is no 
expected direct benefit to the participants we will not include patients with limited English 
proficiency or wards of the state.  
 
DATA AND SAFETY MONITORING 
 
Because this study’s procedures pose minimal risk to the subjects, bimonthly data and procedural 
reviews by the PI in consultation with study staff will be sufficient to identify and ameliorate any 
potential safety issues. Any safety concerns about the equipment or test protocol will be brought 
to the immediate attention of Dr. Rolin. Study staff will conduct bimonthly audits to ensure 
compliance with regulatory requirements for study documentation. 
 
Approval of protocol, informed consent procedures, and recruitment will be obtained from the IRB 
during annual reviews. 
 
Study staff will report any adverse events within 24 hours of its occurrence to the PI. Any serious 
adverse events will be reported immediately to Dr. Rolin. A written report will be submitted to the 
IRB within 48 hours. Remedial action to prevent reoccurrence of the event will be instituted prior 
to the resumption of study procedures. 
 
MONITORING AND QUALITY ASSURANCE 
 
Study staff will conduct bimonthly audits to ensure compliance with regulatory standards for study 
documentation. 
 
PRIVACY AND CONFIDENTIALITY 
 
The study will assign each new subject an alphanumeric identifier, which will henceforth be the 
sole means of identification connected to their data. All data will be collected under this identifier 
and will be kept isolated from any personal health information. All data will be stored locally on a 

secure system. Information shared with individuals outside of Partners will be labeled using an 
alphanumeric identifier and will be devoid of personal health information. 
 
Subjects' parents will be informed of their privacy rights and sign a HIPAA-compliant authorization 
form previously approved by the IRB. 
 
Video recordings on secure VCUHS study sharedrive; only investigators listed on the study will 
have access to them. The video recordings will be destroyed after 7 years from the date of study 
closure in compliance with Partners Record Retention Policy. Patients will be given the choice to 
have video/photo material used for academic articles and presentations. 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE PARTNERS 
 
No specimens will be collected during this study. No personally identifiable data will be sent to or 
viewed by individuals outside of Virginia Commonwealth University Health Systems (VCUHS). 
The study data will not be sold, and publicly available data will not contain any personally 
identifiable information. Subjects will be able to withdraw their data as outlined in Partners HIPAA 
authorization information material and in the informed consent form. Data will not be stored for 
future use not described in the protocol. 
 
RECEIVING SPECIMENS 
 
No specimens or data collected by researchers outside of Partners will be received. 
 
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