Muscle Synergies During Gait in Children With Cerebral Palsy Undergoing Robot-assisted Gait Therapy
Phase: NA
Conditions: Cerebral Palsy
Sponsor: Spaulding Rehabilitation Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Paolo Bonato, PhD 
 
 
PROTOCOL TITLE 
Muscle synergies during the gait in children with cerebral palsy undergoing robot-assisted gait 
therapy. 
 
FUNDING 
 
 
VERSION DATE 
Protocol closed on September 8, 2020 
Last approval on May 3, 2019 
Original approval on October 8, 2015 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
Aim 1. To study the characteristics of muscle synergies in children with cerebral palsy during gait. 
Aim 2. To study the relationship between muscle synergies and the outcomes of robot-assisted gait 
training. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
Cerebral Palsy (CP) is a group of disorders affecting movement, development and posture that 
cause functional limitation, attributed to non progressive alterations occurring in the brain during 
fetal and newborn development1. CP is one of the most common causes of disability in childhood. 
The prevalence rate of CP is approximately 2/1,000 2,3. Clinical features of children with CP 
usually includes weakness, spasticity, and loss of selective motor control (SMC)4. Selective motor 
control has been defined as ‘the ability to isolate the activation of muscles in a selected pattern in 
response to demands of a voluntary movement or posture’4 and the knowledge regarding the 
etiology of selective motor deficits in children with spastic CP is not well studied yet5.  
The scientific community widely accepts that the Central Nervous System (CNS) adopts several 
strategies to reduce the complexity of the control of movement 6-10. Many authors have shown that 
one of these strategies consists in using a limited number of primitive signals undergoing the 
activation of muscles which, when combined, generate a full collection of movements 9. 
Previous studies have shown the sensitive nature of EMG to represent an aberrant motor control 
in CP11. Children with CP utilize fewer synergies during gait than typically developing children. 
The complexity of control, as measured by synergies, is reduced during gait in individuals with 
CP compared with unimpaired individuals and is related to functional ability and clinical measures. 

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The similarity of synergies in CP, stroke, and infant rhythmic-stepping indicates that there are 
common changes in control after brain injury that may reflect control in early development12.  
Training interventions to improve gait outcomes in 
CP usually include strength training, balance 
control and weight bearing activities13. Some 
studies have demonstrated beneficial effects of 
intensive task-specific gait training on motor 
recovery in children with CP14,15.  
Robotics has been looked upon as a means to 
achieve intensity and specificity of gait training, 
which are known to be key “ingredients” needed to 
maximize motor gains16,17. The most prominent 
device used to deliver gait training is the Lokomat 
system (Hocoma AG, Switzerland) shown in 
Figure 1. The system is a driven (i.e., motorized) 
gait orthosis (DGO), namely a computer-controlled 
exoskeleton that is secured to a person’s lower 
limbs while he/she walks on a motorized treadmill 
supported by an unloading system. The DGO is meant to replace the assistance provided by 
therapists during manually-assisted treadmill-based gait training. The DGO records parameters 
such as the joint torques, the range of motion at different joints and the level of assistance provided 
by the robot. These parameters allow therapists to monitor the subject’s response to gait training. 
The Pediatric Lokomat is a DGO for gait training in children. Its safety and benefits on speed, gait 
endurance, gross motor skills (assessed using the Gross Motor Function Measure Scale) 16,18, 
postural control 19, hip extension, step length 20 and spasticity have already been demonstrated in 
many studies. Some of these intervention outcomes have been shown to be retained 6 months post-
therapy 20. In comparison to conventional therapy and manually assisted body weight-supported 
treadmill training, robot-assisted gait training allows for significantly increasing the number of 
steps performed during a single session. Besides, the system can assure the performance of a 
physiological pattern of motion during training. Given its benefits, DGOs like the Lokomat system 
are becoming more and more common in clinical practice. 
We have observed a significant variability in the clinical outcomes of robot-assisted gait training 
in children with CP using the Lokomat robotic system. We hypothesize that the severity of 
impairment in Selective Motor Control (SMC)21 is responsible in large part for the variability in 
responsiveness to robot-assisted gait training observed across children with CP. In the proposed 
project, we intend to explore the use of a recently developed technique designed to analyze the 
activity of muscles. This technique is referred to as the “analysis of muscle synergies”. We observe 
that the study of muscle synergies would allow us to capture the severity of impairments in SMC 
in a way that is more mechanistic (and therefore more informative) than traditional clinical scales 
to assess SMC. Furthermore, we hypothesize that abnormalities in muscle synergies would account 
for the above-mentioned variability in responsiveness to robot-assisted gait training. If this 
hypothesis was found to be true, the proposed approach would allow us to design patient-specific 
rehabilitation interventions that would target abnormalities in muscle synergies that could be used 
prior to the administration of robot-assisted gait training as a way to re-enable motor learning 
strategies that would allow children with CP who are currently not responsive to robot-assisted 
gait training to fully benefit from robot-assisted gait training. If successful, the proposed approach 
would be expected to significantly improve clinical outcomes of robot-assisted gait training in 
children with CP. 
 
 
Figure 1. The driven gait orthosis (Lokomat, by 
Hocoma AG) that we propose to use in the study. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
A convenience sample of 30 children with CP with no major orthopedic or neurological 
complications that could interfere with the gait-training program will be recruited in the study. A 
study clinician will screen potential subjects. Screening will include a standard history and 
physical exam to ensure subjects meet all entry requirements after consideration of inclusion and 
exclusion criteria. 
Inclusion criteria: 
● 
Diagnosis of spastic CP 
● 
6 to 18 years of age. 
● 
Gross Motor Function (GMFCS) Level I, II, III or IV. 
● 
Body/femoral length < size of Lokomat robotic arm (femur length between 210-350mm) 
● 
Ability to communicate pain or discomfort.  
Exclusion Criteria: 
● 
Recent use of Lokomat within the last 3 months. 
● 
Contraindication to robot-assisted gait training such us thromboembolic disease, 
progressive neurologic disorder, cardiovascular or pulmonary contraindications, 
aggressive behaviors, severe cognitive deficits, bone instabilities, fractures, osteoporosis). 
● 
Skin ulcers in trunk or lower limbs. 
● 
Hip, knee, ankle arthrodesis. 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
All study procedures will take place in the Motion Analysis Laboratory at Spaulding Rehabilitation 
Hospital, Boston, Massachusetts, USA. Spaulding Rehabilitation Hospital is an affiliated hospital 
of Harvard Medical School. 
Assessments 
Assessments will be performed before and after the study participant undergoes robot-assisted gait 
therapy. Each assessment will require approximately 4 hours. The majority of this time will be 
spent sitting down, attaching markers and electrodes on the subject, checking the position of the 
markers and sensors, and measuring lengths of body segments. But we will give the option to the 
families of dividing the assessments into two different appointments. 
Visit 1: Clinical tests 
Clinical tests will be conducted by a study staff to assess lower limb function before and after the 
intervention. Throughout the study visit (notably during the clinical testing) if subjects feel tired, 
they will be given every opportunity to rest; this, in addition to regular rest breaks between the test 
trials. Clinical tests will include: 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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• 
The Gross Motor Function Measure (GMFM): this standardized test was designed 
specifically for children with CP and was developed to measure changes over time in 
clinical status. The GMFM is a classification system based on movements initiated by the 
child. It can be used to classify the severity of CP related to mobility. For the purpose of 
this study, the standing and walking sections of the GMFM will be used. 
• 
The 10-meter walk test will be used to assess walking speed. Subjects will be asked to 
ambulate at their normal, comfortable walking speed during the test. Individuals using an 
assistive device during baseline examination will be evaluated with a similar device during 
subsequent tests. To estimate gait speed, time will be recorded during the middle 10m of 
the 14m walk test. We may ask subjects to do this test 3-5 times. Each subject will be 
allowed to rest between trials. 
• 
The 6-minute walk test will be used to measure walking endurance. The test measures the 
distance ambulated during 6 minutes of a continuous walk on a flat, uncarpeted surface. 
An observer walks alongside the subject and provides encouragement and contact guarding 
as needed. Subjects will be asked to do this test once. 
Visit 1: Lab-based study 
Gait evaluations will be performed in the Motion Analysis Laboratory before and after robot-
assisted gait training.  Subjects will be asked to change into shorts and shirt. Measurements of the 
knee and ankle joint and leg lengths will be taken before testing. Surface electromyographic 
(SEMG) data will be gathered to study the characteristics of muscle activation patterns in children 
with cerebral palsy during the gait. Data will be collected using electrodes for the detection of 
EMG activity from muscles that are involved in the gait. Simultaneous recordings of movement 
patterns will be performed using a camera-based system for motion analysis. Movements of the 
upper limbs, trunk and lower limbs, will be tracked using a standard set of reflective markers 
positioned on anatomical landmarks such as acromioclavicular joint, upper arm, lateral epicondyle, 
forearm, wrist, 7th cervical vertebrae, 10th thoracic vertebrae, clavicle, sternum, the sacrum, 
anterior superior iliac spine, lateral thigh, distal lateral epicondyles, lateral shank, lateral malleolus, 
center of calcaneus and second metatarsal head. We will follow the SENIAM (Surface 
Electromyography for the Non-Invasive Assessment of Muscles) guidelines to place up to 16 
electrodes on several muscles involved in the gait pattern, including the following: Gastrocnemius, 
Soleus, Tibialis Anterior, Peroneus longus, Rectus Femoris, Vastus Medialis and Lateralis, 
Sartorius, Biceps Femoris, Semitendinosus, Adductor Longus, Tensor Fascia Latae, Gluteus 
Maximus and Gluteus Medium, Obliquus and erector spinal muscles. The EMG will be attached 
using bio-adhesive double sided tape and secured with Coban. Each subject will be asked to do 
this several times until about 5-10 trials with good foot contacts onto the force plates are collected 
for each side (leg) of the body. Subjects will be asked to complete 5-10 trials walking barefoot (if 
possible), and then 5-10 trials walking in their shoes with any brace(s) they may normally wear. 
Rest breaks will be given during the testing. We will ask permission to study participants to video 
record them during the performance of the above-described clinical tests and the lab-based study. 
Training: 
Body-weight support will be provided using a harness-counterweight system over a motorized 
treadmill. The DGO will be secured to patients at the trunk, pelvis, and lower extremities using 
adjustable cuffs with velcro straps, with hip and knee joints aligned to those of the DGO. The 
DGO, which is attached to the support frame of the treadmill with a 4-bar linkage and a spring-
loaded counterweight system, will provide vertical support and unloading of the device so that the 
weight of the DGO does not contribute to the loading experienced by the patient during the 
training. Actuators at the hip and knee joints will generate a physiological gait pattern timed to the 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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speed of the treadmill belt. Elastic straps will be fitted around the subject’s footwear to ensure 
clearance during swing.  
Each training session will include 30 minutes of walking divided into 3 bouts of 10 minutes. 
During the walking bouts, subjects will be encouraged to walk continuously and as actively as 
possible. Between bouts, children will be allowed to rest for 5 minutes (or longer if necessary). As 
training progresses, we will decrease the amount of body weight support and increase treadmill 
speed. Adjustments will have to vary according to the subject’s ability to maintain upright posture 
and knee extension during heel strike without compromising loading. 
Robot-assisted Gait Therapy Protocol 
• Length of training – A total of 18 training sessions will be performed in approximately 6-
7 weeks. 
• Duration of session – approximately 60 minutes (including about 20 minutes for stretching, 
setup, and warm-up, three 10 min bouts of walking, and 5 min of rest between each bout if 
needed). 
• Speed of training – as determined by patient tolerance and comfort. 
• Body weight support – as small a percentage of body weight as possible to a level that 
allows maximum lower-extremity loading without evidence of excessive knee 
extension/flexion during stance or toe drag during swing. Patients will be encouraged to 
voluntarily generate lower extremity movements that are consistent with the assisted 
stepping pattern. The system provides visual feedback that will be used to encourage joint 
torque generation and achievement of kinematic goals. 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
Treatments for children with cerebral palsy to improve walking usually include strengthening their 
muscles and improving their balance. These help to reduce the effects of weakness, contractures 
and spasticity. Therapeutic options available to decrease spasticity and its impacts on gait are 
usually staggered, and include physical therapy, oral medications, botulinum neurotoxin 
injections, phenol or ethyl alcohol perineural injections, intrathecal baclofen, selective dorsal 
rhizotomy or musculoskeletal surgical procedures. Training by walking on a treadmill is also 
helpful. The Lokomat robot training is an advanced version of training on a treadmill. It is not the 
current standard of care. 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
Risks to participants will be minimized by following the Spaulding Rehabilitation Hospital Policy 
and Procedure: General Safety Precautions and Procedures for the Conduct of Human. All 
laboratory equipment meets or exceeds hospital standards for electrical safety. The DGO that we 
propose to use in the study (i.e., the Lokomat system by Hocoma AG) has been demonstrated to 
be a secure device for pediatric gait training and is equipped with multiple safety tools. Training 
sessions will be always overseen by a therapist trained in the use of robotic systems for gait 
training. The risks of using the Lokomat include muscle soreness and fatigue, but no harmful 
adverse events have been reported with its use in a pediatric population. Subjects will be under 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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constant observation. Trained staff will be nearby to help in case of loss of balance. Subjects will 
be asked prior to using sensors to collect data if they recall any past occurrences of fragile skin, or 
sensitivity to tape or latex. The investigators will use hypo-allergic tapes and bandages that are 
unlikely to cause skin irritation. The padded harness of the DGO will be used with cushioned 
linings and foam padding to minimize contact pressures of the harness, straps and device directly 
on the skin and to prevent abrasions during the bodyweight supported treadmill walking. Subjects 
will also be asked to wear long cotton pants when training with the robot to minimize the 
possibility of skin abrasions. A physician will be available to assist should medical complications 
arise. To minimize fatigue, subjects will be allowed rest periods and will be monitored by study 
staff at all times during the experiments. Confidential information will be kept in a locked filing 
cabinet in the laboratory. 
  
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
Subjects will be screened prior to and during enrollment for the presence of medical conditions 
that may contraindicate their participation. 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The DGO to be used in the study (i.e., the Lokomat system by Hocoma AG) has been demonstrated 
to be a secure device for pediatric gait training and is equipped with multiple safety tools. The 
risks of using the Lokomat include muscle soreness and fatigue, but no harmful adverse events 
have been reported with its use in a pediatric population. 
Subjects with gait disabilities are at higher than normal risk for falls and injuries from daily 
activities. Some of the proposed testing procedures will assess the subject’s performance of 
activities of daily living. In general, subjects will be at no greater risk for falls or injury than when 
walking in the home and community setting. Subjects will be under constant observation. Trained 
staff will be nearby to help in case of loss of balance. 
For individuals with fragile skin, there is a risk of skin irritation from the adhesive tape that secures 
the reflective markers and EMG electrodes to the skin. The risk is equivalent to wearing a Band-
Aid for a few hours and peeling it off. Alcohol cleansing, shaving, and light sanding needed prior 
to positioning sensors might also cause mild skin irritation. It is possible that mild bruising may 
occur from pressure of the sensors against the skin. 
Subjects may become fatigued or uncomfortable during any visit. To minimize fatigue, subjects 
will be allowed rest periods and will be monitored and observed by study staff at all times during 
the experiments. 
 
 
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
It is possible that subjects may not benefit from participating in the study. It is possible that gaining 
a better understanding of the characteristics of muscle activation patterns will eventually lead to 
earlier diagnostic or the development of new rehabilitation protocols. Hence, the study might 
benefit patients in the future. 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
No person will be excluded from participation in the study on the basis of gender, ethnicity or 
race. 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
Non-English speaking subjects will not be excluded from the study. Interpreter services will be 
obtained as necessary to facilitate the informed consent process and study participation. 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 
participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
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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 Spaulding Rehabilitation Hospital may refer their CP patients to 
the study. We will provide physicians with study information sheets and flyers. 
2. Study divulgation through the orthopedic service in the Boston Children’s Hospital and 
Spaulding Rehabilitation Hospital. 
3. Flyers posted in the outpatient specialist clinics, in pediatric and orthopedic clinics, therapy 
gyms and in public spaces inside and outside of the hospital. 
4. Phone calls through volunteer registry. 
5. Via contact with support groups and conferences. 
6. Patients with CP who previously volunteered to be contacted about opportunities to 
participate in research studies at Spaulding Rehabilitation. 
7. Contact with patients who received robot-assisted gait training as part of the clinical 
program at Spaulding Rehabilitation Hospital via referrals from physical therapists. 
8. Via advertisement on clinicaltrials.partners.org and researchmatch.org websites. 
9. Via letter to prospective subjects co-signed by their physician and study PI. 
10. Via contact to the patients listed for direct contact in the Partners Research Patient Data 
Registry (RPDR).  
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
Subjects will be compensated based on the procedures undertaken. The compensation amount 
will be as follows: 
• 
$35 for evaluation sessions 
• 
$15 for intervention sessions 
 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 
 

Partners Human Subjects Research Application Form 
  
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Version Date:  June 1, 2005 
 
  
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CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 
Subjects who are interested and willing to participate in the study will undergo an initial phone 
screening to determine their eligibility. Subjects who qualify will be sent study information and 
will be scheduled to visit the lab and undergo a final screening in person. At the time of the 
scheduled test, the subject will be met by one of the study staff in the Motion Analysis Lab. 
Informed consent will be obtained by the investigators who have completed the Partners 
Healthcare System’s human subject protection educational requirements (i.e. HIPAA), and the 
CITI Program in Protection of Human Subjects, in compliance with all Federal regulations 
regarding such training. Study staff will clearly explain to the subject the nature of the informed 
consent process, study purpose and procedures, time commitments, risks, potential benefits, 
treatment alternatives, rights as research participants, study staff contact information, 
confidentiality procedures, and arrangements for medical care provided in case of injury during 
the study. The subject and his/her parents/guardians will be given adequate time to consider their 
decision and encouraged to ask questions, both during the initial interview and throughout the 
study. A member of the study staff will answer any questions regarding the study at the time 
consent is given. Enrollment will begin when the parents/guardians thoroughly understand and 
signs the informed consent form, and the child thoroughly understands and signs the assent form. 
The subject and parents/guardians will be provided with a signed copy of the completed consent 
and assent form. The subject may pause or terminate his/her enrollment at any time during the 
study. 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        

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NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
Approval of protocol, informed consent procedures, and recruitment will be obtained from the IRB 
during annual reviews. Monthly data and procedural reviews by the PI in consultation with study 
staff will be done to identify and ameliorate any potential safety issues. Any safety concerns about 
the equipment or protocol will be brought to the immediate attention of Dr. Bonato. Study staff 
will conduct bimonthly audits to ensure compliance with regulatory standards for study 
documentation. 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
Study staff will report any adverse event promptly to Dr. Bonato. A written report will be submitted 
to the IRB within 48 hours, and appropriate changes in procedure and protocol will be implemented 
to prevent reoccurrence. Remedial action to prevent reoccurrence of the event will be instituted 
prior to resumption of the study treatment. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The study coordinator will be responsible for monitoring the completeness of all data and source 
documents. The Principal Investigator will monitor the informed consent procedures in accordance 
with the Informed Consent Compliance Checklist of Partners HealthCare. 
 
 
 

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Version Date:  June 1, 2005 
 
  
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For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 
          Adverse Event Reporting Guidelines
          http://healthcare.partners.org/phsirb/adverse_events.htm
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
Patients will be assigned a study number, which will be used for all documentation except for a 
master list matching subjects names and study numbers, and forms for which subjects’ names must 
be recorded (e.g. intake interview forms, copies of reimbursement receipts etc). The master list 
and interview forms will be kept in a secure location in locked offices. No non-study staff will 
have access to any identifiable patient study data or demographic information. All subjects' parents 
will be informed of their privacy rights and sign a HIPAA-compliant authorization form previously 
approved by the Spaulding IRB. Study staff in the Motion Analysis Laboratory will conduct 
quarterly audits to ensure compliance with regulatory standards for study documentation. 
 
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
No personally identifiable data will be sent to or viewed by collaborators outside of SRH.  
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 
Data will not be stored for future use not described in the protocol. 

Partners Human Subjects Research Application Form 
  
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
12 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
This study does not involve receiving data or specimens from outside collaborators.