Augmenting Back Pain Exercise Therapy Using an Interactive Gaming-based Intervention in the Home Setting
Phase: NA
Conditions: Non-specific Chronic Low Back Pain
Sponsor: Spaulding Rehabilitation Hospital

 
 
 
 
May 24, 2019 
 
To Whom It May Concern 
 
The attached documents relate to the study entitled “Augmenting Back Pain Exercise Therapy Using an 
Interactive Game‐Based Intervention in the Home Setting”. The first document is the letter of IRB approval 
for the last year of the study (i.e., the letter for the period from June 2016 to June 2017). The original 
approval was obtained in 2015. The second document is the protocol summary (including a description of 
the planned data analyses). Please notice that the protocol summary was submitted in 2015 to Spaulding 
Rehabilitation Hospital’s IRB and never amended afterwards. Hence, the attached version of the protocol 
summary is dated July 10th, 2015. Review of the study in 2016 for continuing renewal of the study protocol 
led to approval of the use of the protocol dated July 10th, 2015 until June 2017, when the study was 
completed and hence terminated. Although the use of the protocol was approved in 2016 to cover the 
period from June 2016 to June 2017, it is the policy of Spaulding Rehabilitation Hospital’s IRB that the 
protocol summary would show the date when the latest version of the protocol was submitted rather 
than when the continuing renewal application was submitted or when the application was approved. We 
sincerely hope that this policy will not generate any confusion. This letter is to attest that the version of 
the attached version of the protocol summary is the one that was utilized until completion of the project 
in 2017. If you have any additional questions, please feel free to contact our IRB administration, Ms. Line 
J Papin at IRB@partners.org. 
 
Best regards, 
 
 
 
Paolo Bonato, PhD 
Study PI 
pbonato@mgh.harvard.edu 

Continuing Review: Notification of IRB Approval/Activation
Protocol #:    2015P000663/SRH
Date:
June 29, 2016
To:
Paolo Bonato, Ph.D
SRH
Dept of Physical Med and Rehab
From:
Spaulding Rehabilitation Network Research Institute
79/96 Thirteenth Street
Charlestown Navy Yard
Charlestown, MA 02129
Title of Protocol:
Augmenting back pain exercise therapy using an interactive game-based
intervention in the home setting.
Version Date:
7/10/2015
Sponsor/Funding Support:
Name: Departmental Funds
____________________________________________________________
Study Population:
Adults
Consent/Authorization:
Required
Documentation of Consent:
Written
Informed Consent From:
Adult Subject
Informed Consent By:
Non-Physician Investigator
Other Study Staff
IRB Continuing Review #:
1
IRB Review Type:
Full
IRB Approval Date:
6/20/2016
Approval Activation Date:
6/29/2016
IRB Expiration Date:
6/20/2017
This project has been reviewed by SRH IRB #IRB00000817. During the review of this project, the IRB
specifically considered (i) the risks and anticipated benefits, if any, to subjects; (ii) the selection of subjects; (iii)
the procedures for obtaining and documenting informed consent; (iv) the safety of subjects; and (v) the privacy
of subjects and confidentiality of the data.
Please note that if an IRB member had a conflict of interest with regard to the review of this project, consistent
with IRB policies and procedures, the member was required to leave the room during the discussion and vote on
www.spauldingrehab.org
1
Official Version Generated from the Partners Human Research Committee Database 06/29/2016
10:34 AM

this project except to provide information requested by the IRB.
The IRB found that the risks to subjects are minimized and are reasonable in relation to anticipated benefits, if
any, and the importance of the knowledge that may reasonably be expected.  The selection of subjects is
equitable.  Informed consent is sought from each prospective subject and is appropriately documented. 
Adequate provisions are in place for monitoring the data collected to ensure the safety of subjects, protecting
the privacy of subjects, and maintaining the confidentiality of the data.  The study is approved to continue for
(1 year) another year.
Approved Documents:
Protocol Summary - Version Date: June 30th, 2015
Schema
Detailed Protocol - Version Date: June 30th, 2015
Consent Form - Version Date: 7 21 15
Flyer
Phone Screen
Assessment I
Assessment II
Baseline Assessment
Follow-up Assessment
Home-exercise Report
Valedo User Manual
Recruitment Email
At-Home Devices Instruction Manual
Information Sheet
Thank You Letter
Adverse Event Tracking Log
As Principal Investigator, you are responsible for ensuring that this project is conducted in compliance with all
applicable federal, state and local laws and regulations, institutional policies, and requirements of the IRB,
which include, but are not limited to, the following:
1. Submission of any and all proposed changes to this project (e.g., protocol, recruitment materials, consent
form, status of the study, etc.) to the IRB for review and approval prior to initiation of the change(s), except
where necessary to eliminate apparent immediate hazards to the subject(s). Changes made to eliminate
apparent immediate hazards to subjects must be reported to the IRB as an unanticipated problem.
2. Submission of continuing review submissions for re-approval of the project prior to expiration of IRB
approval and a final continuing review submission when the project has been completed.
3. Submission of any and all unanticipated problems, including adverse event(s) in accordance with the IRB’s
policy on reporting unanticipated problems including adverse events.
4. Obtaining informed consent from subjects or their legally authorized representative prior to initiation of
research procedures when and as required by the IRB and, when applicable, documenting informed
consent using the current IRB approved consent form(s)with the IRB-approval stamp in the document
footer.
www.spauldingrehab.org
2
Official Version Generated from the Partners Human Research Committee Database 06/29/2016
10:34 AM

5. Informing all investigators and study staff listed on the project of changes and unanticipated problems,
including adverse events, involving risks to subjects or others.
6. When investigator financial disclosure forms are required, updating your financial interests in Insight and
for informing all site responsible investigators, co-investigators and any other members of the study staff
identified by you as being responsible for the design, conduct, or reporting of this research study of their
obligation to update their financial interest disclosures in Insight if (a) they have acquired new financial
interests related to the study and/or (b) any of their previously reported financial interests related to the
study have changed.
The IRB has the authority to terminate projects that are not in compliance with these requirements.
Questions related to this project may be directed to Catherine E
Sutherland, CSUTHERLAND1@PARTNERS.ORG, 617-952-6182.
CC: Ryan McIntosh, SRH - Dept of Physical Med and Rehab, Non-Study Staff
Catherine P. Adans-Dester, PT, SRH - Dept of Physical Med and Rehab, Research Assistant
www.spauldingrehab.org
Official Version Generated from the Partners Human Research Committee Database 06/29/2016
10:34 AM
3

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
1 
 
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 
Augmenting back pain exercise therapy using an interactive gaming-based intervention in the 
home setting. 
 
FUNDING 
Internal funding 
 
VERSION DATE 
July 10th, 2015 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
Aim: To compare the outcomes of a traditional, exercise-based rehabilitation intervention for 
chronic low back pain with the outcomes achieved by combining a traditional intervention with 
adjunct therapy delivered using an interactive gaming-based system for home-based therapy. 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
1. Background 
Chronic low back pain (cLBP) is among the most burdensome health problems in both 
prevalence and cost of care and it is highly associated with disability, quality of life, emotional 
changes, and work absenteeism1-2. Low back pain (LBP) affects approximately 80% of people at 
some stage in their lives3 and 62% of people experiencing their first episode will develop chronic 
symptoms lasting longer than one year, with 16% of people still sick listed from work at 6 
months4-5. 
The aggregate economic burden of this condition is staggering: $8.15 billion in lost 
productivity (certificated and non-certificated costs included)6 and in the United States, the total 
indirect and direct costs due to LBP are estimated to be greater than $100 billion annually7-8. 
Up to one third of acute low back pain cases may become chronic and lead to disability. 
Around 95% of chronic cases, which presents pain for at least 12 consecutive weeks, are absent 
findings of well-understood causes, i.e. neoplastic, infectious or inflammatory (including pain 
attributed to nerve compression) conditions, and are generally designated as "uncomplicated", 
"non-specific," or "mechanical" LBP9-10. 
Current theories of low back pain chronicity may be divided into cognitive-behavioral, 
biomechanical, and reflex-spasm types. Factors of each type have been shown to be associated 
with cLBP, and this has led to a wide acceptance that chronicity is probably maintained by a 
poorly understood interaction between multiple factors11. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
2 
 
The known risk factors for cLBP include low socioeconomic status, physical attributes 
like obesity, general medical health, environmental factors like physical activity status and    
psychological status like depression, pain-catastrophizing, cognitive style and pain-related fear of 
movement12-15. 
The management of LBP comprises a range of different intervention strategies including 
surgery, drug therapy, and non-medical interventions, such as physiotherapy10. These subjects 
are routinely referred to physiotherapy and the treatment can involve a number of different 
techniques ranging from spinal manipulations, mobilization, advice, general exercises and 
specifically tailored exercises16.  Exercise therapy is recommended as an effective treatment to 
reduce pain intensity and increase functional status when compared to other conservative 
treatments10, 17-19.  
However, to maximize the decrease in pain and disability a home-based exercise prescription 
is an essential addition to the supervised and individually-tailored exercise therapy the subject 
receives with their clinician18, 20. The home-based exercises vary greatly in the method of 
delivery and content21-23 but different programs appear to have similar effects on subjects24-25.  
The main focus  is  the subject adherence to this type of intervention since  many recurring 
cases of low back pain  may have been avoided if the subjects  adhered to their home programs 
during the first treatment plan26. Only a small percentage of the subjects meet the current 
recommendations of their home exercise program.  The combination of exercising and the use of 
technology associated with enjoyment could be an important factor to help with adherence to 
home exercise programs27. 
Recent wearable sensor technologies have been developed, opening many possibilities in 
order to promote benefits in clinic and help in the assessment, monitoring and treatment of 
subjects28-29. Among the main benefits, the wearable sensors showed to be a valid and reliable 
technology30-31, portable, low cost, easy to use, and lightweight31-32.  
Many of the body-worn sensors consist of accelerometers, gyroscopes, footswitches, and/or 
insole pressure sensors, which can quickly and inexpensively provide accurate measures of 
balance and gait for clinical and/or home environments over extended periods of time28-32. 
An example of such a wearable sensor is the Valedo System® by Hocoma AG (Switzerland) 
shown in Figure 1. The Valedo System® is a medical back training device aimed to improve 
compliance and increases motivation by real time augmented feedback based on trunk 
movements made by the subject. The motion sensors (at the chest and low back), attached to the 
skin with double side medical tape, communicate with interactive games displayed on an iPad® 
through Bluetooth and provide a different way to perform therapeutic exercisesinto a motivating 
game environment and guides the subject through exercises specifically designed for low back 
pain therapy. To facilitate challenging the subject and achieving efficient training, the exercises 
can be adjusted according to the subject’s specific needs29, 33-34. Currently, the Valedo System® 
is registered as a 510k device by the FDA and has 17 movements incorporated into 45 
therapeutic exercises, which are designed to target one or a combination of the following 
therapeutic goals: mobilization, stabilization, body control, improvement of movement 
awareness, stretching and balance. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
3 
 
Figure 1:Valedo System (Hocoma AG) for low back pain exercises. 
Home-based rehabilitation interventions based on games may help promote physical and 
cognitive improvements and adherence to physical activity in subjects with Parkinson’s 
Disease35, children with Cerebral Palsy36 and older adults27, 37-39. By gathering accurate and 
objective measures of symptoms, it could reduce the duration and costs of treatment required to 
observe such an effect.  
The aim of this study is to observe the benefits of the home-based rehabilitation program 
using the Valedo system in conjunction with the conventional physiotherapy in subjects with 
cLBP. We hypothesize that, in the same number of sessions, the subjects who undergo Valedo 
home-based exercise and clinic based physiotherapy will receive the same benefit of subjects 
who undergo non-Valedo home-based exercise and clinic based physiotherapy. 
2.    Significance 
Healthcare costs for low back pain (LBP) are increasing. Hence, it is important to provide 
treatments that are effective and cost-effective. There were inconsistent findings regarding the 
cost-effectiveness of home-based rehabilitation based on games for people with cLBP. If it 
becomes clinically relevant for the rehabilitation of these subjects, possibly, the costs and 
number of physiotherapy sessions will decrease. 
 
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. Sample Size: 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
4 
50 subjects with non-specific cLBP will be recruited in the study. Following baseline measures, 
study volunteers will be randomized to either the Usual Care alone group or to the Interactive 
Home-Based System group. In each group, an endpoint assessment session will be conducted at 
approximately 4 and 8 weeks post baseline measures. 
 
B. Inclusion/exclusion criteria: 
Inclusion criteria: 
1. English speaking and reading 
2. Male or female, from age 18 to 65 
3. Back pain subject-rated at > 3 on an 11 point VAS scale (0-10), with a duration > six 
months)  
4. Able to commit to all study visits. 
5. Low back pain attributable to mechanical etiology as opposed to infectious, neoplastic, or 
inflammatory causes. 
6. BMI ≤ 40 
7. Familiar with tablet use 
Exclusion Criteria: 
1. Impairment in vision or mobility interfere with required participation in the study 
2. Current or anticipated receipt of payments from Worker’s Compensation or other insurance 
for disability attributed to low back pain. 
3. Plans to initiate additional treatment for back pain during the period of the study, such as 
acupuncture.  
4. Unresolved musculoskeletal pathology of the lower limbs. 
5. Severe radiculopathic pain. (As a predictor that the candidate will require either surgery or 
epidural analgesia within the next five months) 
6. Alcohol or substance abuse 
7. Prior discectomy or implantation of rods, screws or plates. (Bulging disc without radicular 
pain is not exclusionary; hip or shoulder replacement is not exclusionary) 
8. Current medication with coumadin or prednisone, chronic use of steroid medications, daily 
use of narcotic analgesics, or estrogen supplementation, tricyclic anti-depressants (if not on 
a regular steady dose at least one month prior to enrollment), or any substance that could 
impair balance. 
9. Current diagnosis of: 
a.  Balance problems due to vestibular or other neurological impairments. 
b. Osteoporosis (Osteopina is not an exclusionary condition) 
c. Fibromyaligia 
d. Severe or progressive neurological deficits, including neuromotor impairment 
e. Any hypercoagulation condition 
f. Eczema, Psoriasis, or skin infectionsdeep vein thrombosis 
g. Burns or other acute trauma including unhealed bone fractures or open wounds 
h. Psychiatric illness not well controlled, or current episode of exacerbated major 
depressive disorder. 
i. Rheumatoid arthritis,  

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
5 
10. Any other major medical condition that would impair the subject’s ability to complete the 
study visits. 
11. Any other major medical condition that has not been stabilized, or that would impair the 
subject's ability to complete the activities required by the study. 
 
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.
 
SCREENING AND ENROLLEMENT 
At the first point of contact (usually a phone call), study staff will administer a phone-screening 
questionnaire. Phone screening questionnaires will not contain identifiable information unless 
the subject is eligible and agrees to attend the first visit to give informed consent. Potential 
subjects will also be given the option to attend the screening in person.   
 
If the subject is found eligible for the study after an in-person screening, he/she will be met by an 
investigator and guided through consent procedures. A study staff member trained in human 
subject protection and not involved in subject’s clinical care will conduct the informed consent 
procedures. All subjects will be recruited by IRB approved study staff for this protocol: research 
assistant, co-investigator or principal investigator.  
 
STUDY PROCEDURES 
Assessments sessions:  
At baseline, post-treatment I (after 1-month period), post-treatment II (after completion of 
treatment) sessions will be conducted in the Motion Analysis Laboratory at Spaulding 
Rehabilitation Hospital (SRH) Charlestown, Massachusetts, USA. SRH is an affiliated hospital 
of Harvard Medical School. While the 6 months follow-up assessment will be administered 
either by phone or by email.  Details of data collected in these study visits are given below, in the 
assessment part.  
 
Randomization to intervention:  
Following baseline measures, subject will be randomized with equal probability (50/50) and 
stratified by gender to one of two groups by opening the next in a previously prepared series of 
envelopes containing randomly determined assignments:  
A. Control (Usual Care group):  
Subjects will receive a combination of physical therapy and home exercise program 
during 8 to 12 weeks. Home exercise will be recommended at least two times a week. 
Usual Care of LBP provided in SRH consists of exercises and manual therapy in 
various combinations according to the needs of the subject. Subjects will fill out a 
questionnaire about their pain and how much time they spent doing the home 
exercises every two weeks.  
B. Intervention (Interactive Home-Based System group):  
Subjects randomized to this group will receive a combination of physical therapy 
(during 8 to 12 weeks) and at least two sessions of interactive exercises program at 
home with the Valedo® System (Hocoma AG). The system will be loaned at no cost 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
6 
to the subject and a research assistant will explain to the subject how to use the 
Valedo system safely (including care and storage of the device components). Subjects 
will fill out a questionnaire about their pain and send us the PDF report from the 
Valedo system (including time spend exercising and quality of movement) every two 
weeks during the treatment period. 
 
Concurrent medications and other therapies: Enrolled subjects will continue any existing 
prescribed medications. They will be asked not to change their prescription medications unless 
their physician requests it. We will ask them to inform us of any such changes. Enrolled subjects 
will also be asked not to receive any type of adjunct therapy other than that provided by this 
study during the period of their participation. However, if a treating clinician decides that 
additional therapy treatment is necessary for their optimal medical care, it will be allowed.  
All changes in medications and/or therapies during the course of the study we will be recorded in 
the subject file. 
     
Assessments:  
Four assessments points:  
1. Baseline  
(before intervention) 
2. Post-treatment I  
(after 1-month period)  
3. Post-treatment II  
(after completion of treatment) 
Test Battery I 
About 2 hours visit, at the Motion 
Analysis Laboratory at Spaulding 
Rehabilitation Hospital (SRH). 
4. Follow-up at 6 months 
Test Battery II 
administered either by phone or by 
email 
 
 
TEST BATTERY I:  
 Based on Patient Reported Outcomes Measurements recommended for cLBP 
studies40-41 and include the following:  
Instruments  
 
 
Sensitivity, Reliability 
 
    Items 
VAS Pain:  
"How bothersome has your low 
back pain been during the past 
week" (Primary outcome) 
The most widely accepted type of 
pain questionnaire, excellent 
reliability, adequate validity, and 
sensitive to change in clinical 
populations.
0-10 cm,  
anchored from "none" 
to "highest 
imaginable." 
Pain Frequency:  
“How many days did you have 
low back pain during the last 
week” 
 
0-7 days in the week. 
Owestry Low Back Pain  
Disability Questionnaire  
It measures a subject's permanent 
functional disability
10 disability 
graduation items
Days disabled:  
i) days of restricted activity due to 
Adapted from the National Health 
Interview Survey.
Two integer values 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
7 
back problems  
ii) number of half days spent in 
bed, home from work or school or 
cutting down on usual activity. 
SF-36 
Widely used general health status 
questionnaire. Normed on large 
and diverse populations, 
demonstrated validity; reliability 
coefficients from 0.72-0.93. 
36 questions, 
variously yes/no or 
Likert scales of from 
3 to 6 anchored 
points. 
Global satisfaction with care: 
"Over the course of treatment for 
your low back pain in this study, 
how would you rate your overall 
medical care?"  
(Asked at post-treatment I and II) 
Recommended by an international 
group of back pain researchers. 
7 point Likert scale, 
anchored from -3 
(extremely 
dissatisfied) to +3 
(extremely satisfied). 
 
 Standing postural sway parameters computed form force plate data (AMTI®, 
Watertown, MA): Data will be collected from each subject in three stances: two-footed parallel 
with eyes closed, one-footed balance on left foot with eyes open, one-footed balance on right 
with eyes open. One-footed tasks will last for 30 seconds, with data recorded from the final 20 
secs; two-footed tasks will last 70 seconds, with data recorded continuously for the final 60 
seconds. Rest periods will be provided between tasks as necessary. For the sake of reliability, 
each task will be performed 5 times. Additionally, the subject will wear an accelerometer 
(Shimmer), the device will be positioned on First Sacrum vertebrae. Finally, opto-kinematic data 
will be collected using a set of reflective markers attached to the skin using medical double-sided 
adhesive tape. Markers will be attached to the feet (lateral malleolus) of the subject in order to 
assess the lateralization movement during the balance task. 
 
Raw data will be low-pass filtered to attenuate noise, and computer processed to generate 
parameters averaged across three trials of each task:  
Parameter 
 
 
 
 
 
Sensitivity & Reliability 
Average velocity of center 
of pressure (avgCOPvel) 
For one-footed task with eyes open, avg COPvel was 
significantly higher in severe cLPB/controls (p=0.0003), with 
ROC=0.54. Change values pre/post rehabilitation therapy were 
sig different for "poor outcome" versus controls (p=0.04). 1 
week test-retest trials were within 95% standard deviation. 
Similar reliability and sensitivity of avgCOPvel have been 
Figure 2: Accelerometer sensor (Shimmer)

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
8 
reported for one-footed stance w/eyes closed. 
Root mean square of COP 
medio-lateral excursion 
(RMSml) 
RMSml significantly differentiated cLBP from controls in 2-
footed eyes closed task (p=0.031); the forward lean with eyes 
closed task showed largest between group differences 
(p=0.0002). Reliability was ICC = 0.89 for eyes closed; 0.64 for 
forward lean w/eyes closed.
Mean shear force anterior-
posterior (mSFa-p) 
Reliability reported at r=0.98 
 
 Only at baseline, anthropometric data (height and weight) cognitive-behavioral factors 
and psychological morbidity will be assessed and include the following:  
Instruments  
 
 
Sensitivity, Reliability 
 
Items 
Pain Catastrophizing Scale 
Validity and reliability established.
13 items, scored on 5 
point scales anchored 
from 
0="totally 
disagree" to 4 "totally 
agree." 
Tampa Scale of Kinesiophobia 
 Internal consistency in acute LBP 
varies between alpha - 0.70-0.80, 
test-retest reliability r=0.78-0.79. 
17 items scored on 5 
point Likert scales 
anchored 
from 
"strongly disagree to 
"strongly agree."
Hospital Anxiety and Depression 
Scale 
Validated for detecting mild mood 
disorders in non-psychiatric 
outsubjects; excludes physical 
symptoms to avoid confounding in 
groups of medical subjects. 
14 items; sub-scales 
for anxiety and for 
depression; designed 
to 
minimize 
confounding 
by 
subjects' 
somato-
sensory symptoms.
Whiteley Index-7 
Validated with primary care 
subjects for identification of 
somatoform disorders; widely used 
as a measure of somatization; high 
internal validity. 
7 items; sub-scales 
for Illness Worrying 
and 
Illness 
Conviction. 
 
At the end of the training period, the research coordinator will collect all the devices lent for the 
duration of the study to the subject. The devices include: one tablet and the Valedo box 
containing 2 sensors, 1 USB charging cable, a user manual and quick reference guide. If the 
subject fails to return the devices or intentionally damage them, the principal investigator will 
contact them and he/she will be responsible for their cost. 
 
TEST BATTERY II:  
This last interview will be administered either by phone call or by email, depending on subject 
prefrerence. It will be done at 6 months after the baseline assessment and include the following 
instruments:  
 
Instruments  
 
 
 
Sensitivity, Reliability 
 
Items 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
9 
NAS Pain:  
"How bothersome has your low 
back pain been during the past 
week"  
(Primary outcome) 
The most widely accepted type 
of pain questionnaire, excellent 
reliability, adequate validity, and 
sensitive to change in clinical 
populations.
0-10 cm, anchored 
from "none" to 
"highest imaginable." 
Pain Frequency:  
“How many days did you have low 
back pain during the last week” 
 
0-7 days in the week. 
Owestry Low Back Pain  Disability 
Questionnaire  
It measures a subject's 
permanent functional disability
10 disability 
graduation items
Days disabled:  
i) days of restricted activity due to 
back problems,  
ii) number of half days spent in 
bed, home from work or school or 
cutting down on usual activity. 
Adapted from the National 
Health Interview Survey. 
Two integer values 
 
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.
Usual care for cLBP may also include oral medication, injection medication, and exercise-based 
physical therapy. Therapy interventions vary across clinical centers and rely on the experience of 
the individual physical therapist or prescribing physician. Surveys of the United States have 
found high rates of complementary therapy use by patients suffering from back (54%) and/or 
neck (37%) pain, with chiropractic, massage and relaxation techniques being the most common, 
each of which is readily available in the Boston area 42-43. 
 
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.
Minimizing risks: 
- In-person and phone-based questionnaires data: on low back related pain and disability, other 
therapeutic outcomes, and psychological data will be collected by patient-completed instruments 
that have been widely used in cLBP research and entail no significant risk to patients44-46. The 
risk of discomfort will be minimized by assuring subjects that they may decline to answer any of 
the questions asked. The risk of public disclosure of their responses will be minimized by using 
subjects study code and date only, deletion of any personally identifying information from the 
transcripts, storage of the files in the locked file cabinet and on the lab’s secure server. 
- Biomechanical data: the conduct of measures sessions will be supervised by Paolo Bonato, 
PhD, director of MAL, and his research assistants. Subjects will be supervised by trained study 
staff during all tests and will be monitored for indications of adverse events. Subject may 
become tired during the test, they will be given regular rest breaks during testing, and between 
trials if necessary, during which they will be allowed to rest until ready to resume. To minimize 
the risk that a subject may have an allergic reaction to the adhesive tape used to secure reflective 
markers to the skin, we will use hypo-allergenic tapes.  
- Intervention: 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
10 
Subjects might become tired or sore due to the exercises prescribed by their therapists for cLBP 
treatment. Physical therapists will monitor patients for signs of adverse effects during treatment 
sessions by questioning and visual observation. 
To minimize the risk that a subject may have an allergic reaction to the adhesive tape used to 
secure the Valedo System® to the skin, we will use hypo-allergenic tapes. Research assistant 
will explain to the subject how to use the Valedo system safely (including care and storage of the 
device components) and instruct them to stop the session if pain or fatigue occur and get in 
contact with us. Additionally, research assistants will follow-up by phone every two weeks in 
ensure compliance and safety.  
 
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 might make their participation in the study unsafe. During their participation, they will be 
screened and monitored by their physical therapist and experienced study staff for any possible 
adverse event they might encounter. Experiences study staff will guard subjects while they 
perform all the procedures. Subjects who begin study participation will be withdrawn from the 
protocol under the following circumstances: 
- 
If the subject cLBP worsen while undergoing study procedures; 
- 
If the risk-benefit ratio is no longer respected; 
- 
If their treating physician request to stop the Interactive Home-Based program. 
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 collection of demographic, anthropometric, medical history and subject safety data entail 
no significant risk in themselves. The same is true of qualitative interviews when subjects are 
permitted to pass on any questions they would rather not answer. 
- 
Therapeutic outcomes and psychological data will be collected entirely by subject-completed 
questionnaires which have been very widely used in other trials and entail no significant risk. 
- 
Biomechanical data: Procedures for the collection of biomechanical data will follow 
established procedures with which Motion Analysis Lab (MAL) personnel are familiar and 
which entail minimal risk. Risks include the low possibility that a subject could fall or trip 
while walking, that a subject may become tired during a test. The sensors (Shimmer) used in 
this study are powered by low voltage batteries and are completely isolated from other 
electrical sources such as power lines. Subjects will be questioned prior to sensors and 
markers application for past occurrences of fragile skin, or sensitivity to tape or latex. The 
investigators will use tapes least likely to irritate the skin. For persons with fragile skin, there 
is a risk of skin irritation from the adhesive that secures the sensor to the skin. The risk is 
equivalent to wearing a Band-Aid for a few hours and peeling it off. All laboratory 
equipment meets or exceeds hospital standards for electrical safety. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
11 
- 
Risks and discomforts of interventions: 
Usual Care: exercise or manual therapy may cause transient soreness or pain.  Side effects of 
established pain medications are generally mild to moderate. 
Interactive Home-Based Gaming System: exercise may cause transient soreness or pain.  Side 
effects of established pain medications are generally mild to moderate. They might present 
some skin irritation due to the adhesive tape used to secure the sensor used in the Valedo 
System®, we are providing them with hypo-allergenic medical double-sided tape to reduce 
the risks. 
 
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 subjects with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
Subjects may experience an improvement in the symptoms of their low back pain and/or 
function, or they may derive no direct benefit. The results of these studies may benefit future 
patients if the findings of this study show that the Valedo System® improved compliance and 
symptoms of cLBP. Data obtained from this research may lead to larger, adequately powered 
studies to test the hypothesized therapeutic impact of Home-Based Therapy with on cLBP, and 
of the mechanistic factors hypothesized to contribute to that impact. 
 
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.
Subject with low back pain attributable to infectious, neoplastic, or inflammatory causes will be excluded 
from the study due to confounding effects of brain development on stroke recovery. The 
distribution of subjects across gender, ethnic, and racial classes will be determined by exposure 
to the planned recruitment methods cited above at SRH. No person will be excluded from 
participation in this study on the basis of gender, ethnic, or racial group. 
 
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 be excluded from the study because the software of the 
Valedo System® is English only and we want subject to be able to use the device appropriately 
for their own safety. 
 
For guidance, refer to the following Partners policy: 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
12 
          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.
Potential subjects will be identified by the following sources: 
Printed flyers will be given to physical therapy departments of participating hospitals. 
1. Referrals from Physical Therapists. 
2. Flyers posted in the outpatient clinics, therapy gyms and in public spaces inside and 
outside of the hospital. 
3. The Partners RSVP for health website. 
4. Via research recruitment emails, for example Spaulding Rehabilitation Network 
Research Recruitment emails, and Social Medias.  
5. Via contact to the patients listed in the Partners Research Patient Data Registry (RPDR).  
 
Eligible patients will be asked to either contact study staff or give permission to be contacted by 
study staff to obtain more information about the study and give informed consent.  
 
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 amount of compensation 
will be as follows: 
- 
$50 for the in-person assessment session (up to 3 visits: baseline, post-treatment I, and 
post-treatment II). 
- 
$10 for each completed Subject’s Questionnaire that is received by study staff (up to 4). 
- 
$20 for the follow-up phone/email interview. 
Each subject will receive up to $210 for completing the whole study.  Additionally, parking fees 
at the Spaulding Rehabilitation Hospital will be reimbursed ($5). 
 
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  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
13 
 
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 subjects, describe how the potential for coercion will be avoided.
At the first point of contact (usually a phone call), study staff will administer a phone-screening 
questionnaire. Phone screening questionnaires will not contain identifiable information unless 
the subject is eligible and agrees to attend the first visit to give informed consent. Potential 
subjects will also be given the option to attend the screening in person.   
 
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 from the Motion Analysis Laboratory 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 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 subject thoroughly understand and signs the 
informed consent form. The 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.        
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
14 
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. Quarterly 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 Systems 
HRQIP. The subject’s data/protocol adherence will be monitored by the study coordinator at 
each step in the study.  
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
15 
          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.
Subjects 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 subject study data or demographic information. All subjects 
will be informed of their privacy rights and receive a HIPAA privacy notice booklet. 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. 
 
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.

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
16 
 This study does not involve receiving data or specimens from outside collaborators. 
 
 
REFERENCES
 
1. 
Luo X, Pietrobon R, Sun SX, Liu GG, Hey L. Estimates and patterns of direct health care expenditures 
among individuals with back pain in the United States. Spine. Jan 1 2004;29(1):79-86. 
2. 
Mathew J, Singh SB, Garis S, Diwan AD. Backing up the stories: The psychological and social costs of 
chronic low-back pain. International journal of spine surgery. 2013;7:e29-38. 
3. 
Beith ID, Kemp A, Kenyon J, Prout M, Chestnut TJ. Identifying neuropathic back and leg pain: a cross-
sectional study. Pain. Jul 2011;152(7):1511-1516. 
4. 
Andersson GB. Epidemiological features of chronic low-back pain. Lancet. Aug 14 1999;354(9178):581-
585. 
5. 
Hestbaek L, Leboeuf-Yde C, Manniche C. Low back pain: what is the long-term course? A review of 
studies of general patient populations. European spine journal : official publication of the European Spine 
Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research 
Society. Apr 2003;12(2):149-165. 
6. 
Walker BF, Muller R, Grant WD. Low back pain in Australian adults: the economic burden. Asia-Pacific 
journal of public health / Asia-Pacific Academic Consortium for Public Health. 2003;15(2):79-87. 
7. 
Frymoyer JW, Cats-Baril WL. An overview of the incidences and costs of low back pain. The Orthopedic 
clinics of North America. Apr 1991;22(2):263-271. 
8. 
Crow WT, Willis DR. Estimating cost of care for patients with acute low back pain: a retrospective review 
of patient records. The Journal of the American Osteopathic Association. Apr 2009;109(4):229-233. 
9. 
Von Korff M, Saunders K. The course of back pain in primary care. Spine. Dec 15 1996;21(24):2833-2837; 
discussion 2838-2839. 
10. 
Airaksinen O, Brox JI, Cedraschi C, et al. Chapter 4. European guidelines for the management of chronic 
nonspecific low back pain. European spine journal : official publication of the European Spine Society, the 
European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. Mar 
2006;15 Suppl 2:S192-300. 
11. 
Geisser ME, Haig AJ, Wallbom AS, Wiggert EA. Pain-related fear, lumbar flexion, and dynamic EMG 
among persons with chronic musculoskeletal low back pain. The Clinical journal of pain. Mar-Apr 
2004;20(2):61-69. 
12. 
Rubin DI. Epidemiology and risk factors for spine pain. Neurologic clinics. May 2007;25(2):353-371. 
13. 
Swinkels-Meewisse IE, Roelofs J, Oostendorp RA, Verbeek AL, Vlaeyen JW. Acute low back pain: pain-
related fear and pain catastrophizing influence physical performance and perceived disability. Pain. Jan 
2006;120(1-2):36-43. 
14. 
Woby SR, Watson PJ, Roach NK, Urmston M. Adjustment to chronic low back pain--the relative influence 
of fear-avoidance beliefs, catastrophizing, and appraisals of control. Behaviour research and therapy. Jul 
2004;42(7):761-774. 
15. 
Pincus T, Burton AK, Vogel S, Field AP. A systematic review of psychological factors as predictors of 
chronicity/disability in prospective cohorts of low back pain. Spine. Mar 1 2002;27(5):E109-120. 
16. 
Liddle SD, David Baxter G, Gracey JH. Physiotherapists' use of advice and exercise for the management of 
chronic low back pain: a national survey. Manual therapy. Apr 2009;14(2):189-196. 
17. 
Chou R, Huffman LH, American Pain S, American College of P. Nonpharmacologic therapies for acute 
and chronic low back pain: a review of the evidence for an American Pain Society/American College of 
Physicians clinical practice guideline. Annals of internal medicine. Oct 2 2007;147(7):492-504. 
18. 
Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific 
low back pain. Annals of internal medicine. May 3 2005;142(9):765-775. 
19. 
van Middelkoop M, Rubinstein SM, Verhagen AP, Ostelo RW, Koes BW, van Tulder MW. Exercise 
therapy for chronic nonspecific low-back pain. Best practice & research. Clinical rheumatology. Apr 
2010;24(2):193-204. 
20. 
Oesch P, Kool J, Hagen KB, Bachmann S. Effectiveness of exercise on work disability in patients with 
non-acute non-specific low back pain: Systematic review and meta-analysis of randomised controlled trials. 
Journal of rehabilitation medicine. Mar 2010;42(3):193-205. 
21. 
Quittan M. Management of back pain. Disability and rehabilitation. May 20 2002;24(8):423-434. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
17 
22. 
Swinkels IC, van den Ende CH, van den Bosch W, Dekker J, Wimmers RH. Physiotherapy management of 
low back pain: does practice match the Dutch guidelines? The Australian journal of physiotherapy. 
2005;51(1):35-41. 
23. 
Moffett J, McLean S. The role of physiotherapy in the management of non-specific back pain and neck 
pain. Rheumatology. Apr 2006;45(4):371-378. 
24. 
Slade SC, Keating JL. Trunk-strengthening exercises for chronic low back pain: a systematic review. 
Journal of manipulative and physiological therapeutics. Feb 2006;29(2):163-173. 
25. 
Slade SC, Keating JL. Unloaded movement facilitation exercise compared to no exercise or alternative 
therapy on outcomes for people with nonspecific chronic low back pain: a systematic review. Journal of 
manipulative and physiological therapeutics. May 2007;30(4):301-311. 
26. 
Linton SJ, Hellsing AL, Bergstrom G. Exercise for workers with musculoskeletal pain: Does enhancing 
compliance decrease pain? Journal of occupational rehabilitation. Sep 1996;6(3):177-190. 
27. 
Monedero J, Lyons EJ, O'Gorman DJ. Interactive video game cycling leads to higher energy expenditure 
and is more enjoyable than conventional exercise in adults. PLoS One. 2015;10(3):e0118470. 
28. 
Bonato P. Wearable sensors and systems. From enabling technology to clinical applications. IEEE 
engineering in medicine and biology magazine : the quarterly magazine of the Engineering in Medicine & 
Biology Society. May-Jun 2010;29(3):25-36. 
29. 
Bonato P. Advances in wearable technology and applications in physical medicine and rehabilitation. J 
Neuroeng Rehabil. Feb 25 2005;2(1):2. 
30. 
Mancini M, Salarian A, Carlson-Kuhta P, et al. ISway: a sensitive, valid and reliable measure of postural 
control. J Neuroeng Rehabil. 2012;9:59. 
31. 
Mancini M, King L, Salarian A, Holmstrom L, McNames J, Horak FB. Mobility Lab to Assess Balance and 
Gait with Synchronized Body-worn Sensors. Journal of bioengineering & biomedical science. Dec 12 
2011;Suppl 1:007. 
32. 
Frontera W. The importance of technology in rehabilitation. IEEE engineering in medicine and biology 
magazine : the quarterly magazine of the Engineering in Medicine & Biology Society. May-Jun 
2003;22(3):25. 
33. 
Patel NV, Bigal ME, Kolodner KB, Leotta C, Lafata JE, Lipton RB. Prevalence and impact of migraine and 
probable migraine in a health plan. Neurology. Oct 26 2004;63(8):1432-1438. 
34. 
http://www.hocoma.com/en/products/valedo/. 2015. 
35. 
Natbony LR, Zimmer A, Ivanco LS, Studenski SA, Jain S. Perceptions of a Videogame-Based Dance 
Exercise Program Among Individuals with Parkinson's Disease. Games for health journal. Aug 
2013;2(4):235-239. 
36. 
Sandlund M, Waterworth EL, Hager C. Using motion interactive games to promote physical activity and 
enhance motor performance in children with cerebral palsy. Developmental neurorehabilitation. 
2011;14(1):15-21. 
37. 
Maillot P, Perrot A, Hartley A. Effects of interactive physical-activity video-game training on physical and 
cognitive function in older adults. Psychology and aging. Sep 2012;27(3):589-600. 
38. 
Bleakley CM, Charles D, Porter-Armstrong A, McNeill MD, McDonough SM, McCormack B. Gaming for 
health: a systematic review of the physical and cognitive effects of interactive computer games in older 
adults. Journal of applied gerontology : the official journal of the Southern Gerontological Society. Apr 
2015;34(3):NP166-189. 
39. 
Studenski S, Perera S, Hile E, Keller V, Spadola-Bogard J, Garcia J. Interactive video dance games for 
healthy older adults. J Nutr Health Aging. Dec 2010;14(10):850-852. 
40. 
Deyo a. Research Standards for Chronic Low Back Pain. Journal of Manipulative and Physiological 
Therapeutics. July 8, 2014 2014;37(7):449-467. 
41. 
Deyo RA, Dworkin SF, Amtmann D, et al. Report of the National Institutes of Health task force on 
research standards for chronic low back pain. Journal of manipulative and physiological therapeutics. Sep 
2014;37(7):449-467. 
42. 
Eisenberg D, Davis RB, Ettner SL, Appel S, Wilkey S, Van Rompay M, Kessler RC. Trends in alternative 
medicine use in the United States, 1990-97: results of a follow-up national survey. JAMA. 
1998;280(18):1569-1575. 
43. 
Wolsko P, Eisenberg DM, DAvis RB, Kessler R, Phillips RS. Patterns and perceptions of care for treatment 
of back and neck pain: results of a national survey. Spine. 2003;28(3):292-297. 
44. 
Bombardier C. Outcome assessments in the evalution of treatment of spinal disorders: summary and 
general recommendations. Spine. 2000;25(24):3100-3103. 
45. 
Deyo R, Battie M, Beurskens AJ, Bombarider C, Croft P, Koes B, et al. Outcome measures for low back 
pain research. a proposal for standardized use. Spine. 1998;23(18):2003-2013. 

Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
18 
46. 
Schaufele M, Boden SD. Outcome research inpatients with chronic low back pain. Orthoped Cln N Amer. 
2003;35:231-237.