The Effect of Volitional Transversus Abdominis Contraction on Time to Peak Sagittal Ground Reaction Force in Patients With Knee Osteoarthritis
Phase: NA
Conditions: Osteoarthritis, Knee
Sponsor: Louisiana State University Health Sciences Center Shreveport

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 1 of 12 
 
 
 
PROTOCOL TITLE: 
The Effect of Volitional Transversus Abdominis Contraction on Time to Peak 
Sagittal Ground Reaction Force during Gait in Patients with Knee Osteoarthritis 
PRINCIPAL INVESTIGATOR: 
Daniel Flowers, PT, DPT, OCS 
Program in Physical Therapy, Department of Rehabilitation Sciences, School of 
 
Allied Health Professions 
318-813-2958 
dflowe@lsuhsc.edu 
VERSION NUMBER: 
Version 2 
DATE: 
Submission date: 3/17/17 
Revision date: 3/21/17 
 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 2 of 12 
 
Table of Contents 
1.0 
Objectives* .............................................................................................................. 3 
2.0 
Background* ............................................................................................................ 3 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 4 
4.0 
Study-Wide Number of Subjects* ........................................................................... 5 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 5 
6.0 
Multi-Site Research* ............................................................................................... 5 
7.0 
Study Timelines* ..................................................................................................... 5 
8.0 
Study Endpoints* ..................................................................................................... 5 
9.0 
Procedures Involved*............................................................................................... 5 
10.0 Data and Specimen Banking* .................................................................................. 7 
11.0 Data Management* .................................................................................................. 7 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* .......................... 8 
13.0 Withdrawal of Subjects* .......................................................................................... 8 
14.0 Risks to Subjects* .................................................................................................... 9 
15.0 Potential Benefits to Subjects* ................................................................................ 9 
16.0 Vulnerable Populations* .......................................................................................... 9 
17.0 Community-Based Participatory Research* ............................................................ 9 
18.0 Sharing of Results with Subjects* ........................................................................... 9 
19.0 Setting ...................................................................................................................... 9 
20.0 Resources Available................................................................................................. 9 
21.0 Prior Approvals ...................................................................................................... 10 
22.0 Recruitment Methods ............................................................................................. 10 
23.0 Local Number of Subjects ..................................................................................... 11 
24.0 Confidentiality ........................................................ Error! Bookmark not defined. 
25.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 11 
26.0 Compensation for Research-Related Injury ........................................................... 11 
27.0 Economic Burden to Subjects ................................................................................ 11 
28.0 Consent Process ..................................................................................................... 11 
29.0 Process to Document Consent in Writing .............................................................. 12 
30.0 Drugs or Devices.................................................................................................... 12 
 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 3 of 12 
 
1.0 
Objectives* 
1.1 The purpose of this study is to study the effects of core activation on 
knee joint loading during ambulation in patients with knee 
osteoarthritis (OA). This study aims to investigate the effects of 
transversus abdominis (TA) activation during simultaneous kinetic 
analysis of time to initial peak ground reaction force (T1) at the heel 
in the sagittal plane.  
The objective of this study is to determine whether patients with 
knee OA demonstrate changes in T1 during comfortable gait speeds 
when actively contracting the TA muscle. In addition, this study will 
serve as a pilot study in order to perform a post-hoc power analysis 
for future study on the effects of the independent variable (TA 
contraction/changes in core stability) on the dependent variable (T1). 
1.2 Null hypothesis: There will be no change in T1 in patients with knee 
OA during gait while contracting their TA. 
Alternate hypothesis: There will be a decrease in T1 in patients with 
knee OA during gait while contracting their TA. 
 
2.0 
Background* 
2.1 This will be the first study on this topic performed by the 
investigator. Regarding current knowledge gaps, evidence has shown 
an influence of core strength measures/stability on lower extremity 
function. This relationship has been examined very little in patients 
with knee OA; however, evidence does show a correlation exists. 
There have been no studies examining the effect of a core 
strengthening/stability intervention on lower extremity kinetics in 
patients with knee OA to the PIs knowledge. 
2.2 This is the first study examining the effects of TA contraction knee 
loading during gait in this population.  
2.3 Current evidence shows that core activation/stability may play a role 
in lower extremity kinetics and kinematics. Most research has 
focused on younger, more athletic individuals. Research on this 
population has in the past looked at patellofemoral disorders or 
ligamentous injury. For example, decreased core function has been 
shown to increase the risk of sustaining anterior cruciate ligament 
injury. In addition, increased core stability has resulted in decreased 
knee loading during athletic activities. 
There continues to be an overall paucity of research on proper prescription  

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 4 of 12 
 
and dosage of therapeutic exercise for patients with knee OA. Evidence has 
shown that quadriceps strengthening and aerobic conditioning do lead to 
decreased disability. Additionally, correlations have been shown between 
core stability and functional ability as measured via the Western Ontario and 
McMaster Universities Osteoarthritis Index. Patients with knee OA also 
exhibit decreased overall core stability as compared to healthy controls. This 
body of research however does not include any evidence on the effects of a 
core stability intervention on improving overall function. 
 
Knee OA leads to abnormalities in kinetic loading of the lower extremity 
during ambulation. An increase in T1 in this population has been observed 
when comparing to healthy controls. Separately, studies have shown that in 
patients with knee OA, knee joint loading can be influenced by intraarticular 
hyaluronic acid injections, resulting in decreased T1. Therefore, this study 
will explore the idea of how activation of a muscle (TA), which plays a 
large role in core stability, influences kinetic loading (T1) during ambulation 
in patients with knee OA.  
 
3.0 
Inclusion and Exclusion Criteria* 
3.1 The PI will screen potential participants either in person, via medical 
record review (TherapySource in Rehabilitation Faculty Practice 
Clinic), or via phone conversation. The PI will also ask other 
clinicians if they are aware of anyone who may meet the inclusion 
criteria who may be willing to participate. 
3.2 Inclusion criteria for the study will include those with medical 
diagnosis (providing written evidence from a physician, physician 
assistant, or nurse practitioner) of knee OA unilaterally or bilaterally. 
Exclusion criteria for the study will include: bilateral total knee 
arthroplasty, requirement of an assistive device or assistance with 
ambulation, spinal diagnoses which contraindicate participation in 
spinal stabilization activities, and those currently limited by another 
lower extremity pathology at the time of participation. 
3.3 The following populations will be excluded from participation. 
Adults unable to consent may have difficulty following the cues to 
activate the TA while ambulating. Pregnancy women and younger 
individuals do not typically present with knee OA. Prisoners are 
admitted for treated in the School of Allied Health Professions 
(SAHP) as they are all served by University Health facilities. 
 
Adults unable to consent 
 
Individuals who are not yet adults (infants, children, teenagers) 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 5 of 12 
 
 
Pregnant women 
 
Prisoners 
4.0 
Study-Wide Number of Subjects*: NA 
 
5.0 
Study-Wide Recruitment Methods*: NA 
 
6.0 
Multi-Site Research*: NA 
 
7.0 
Study Timelines* 
7.1 Each participant will only be required to participate for one session, 
lasting about 1 hour. This does not included the informed consent 
process requiring approximately 30 minutes of their time prior to 
participation. Approximately 5 months will be required to enroll all 
participants. It is the PI’s goal to complete primary data analysis no 
more than 3 months after data collection is complete, so total 
estimated study time is 8 months. 
8.0 
Study Endpoints* 
8.1 The primary study endpoint will be the cessation of data collection 
and the participants’ active participation in the research program. 
The Secondary endpoint will be the completion of data analysis, 
which concludes the management of PHI. 
8.2 Primary (exposure to any physical risk) and secondary (management 
of PHI) safety endpoints are synonymous with the study endpoints 
mentioned in 8.1. 
9.0 
Procedures Involved* 
9.1 This project serves as pilot study for future investigation on the role 
of core stabilization on gait kinetics in patients with knee OA. 
Therefore the sample size will be small. Post-hoc power analysis will 
inform the PI about requirements for participant recruitment needs 
for future investigations. 
9.2 After informed consent is completed, participants will be scheduled 
for a session in the Motion Analysis Laboratory in the SAHP. 
Patients will have already been asked to wear close fitting, exercise 
appropriate clothing to allow marker placement, and prevent marker 
blocking during motion analysis. Data collection will begin by 
collecting the following anthropometric data: body weight (pounds, 
converted to kilograms) via a scale, height (inches, converted to mm) 
via a tape measure, leg length from ipsilateral anterior superior iliac 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 6 of 12 
 
spine to ipsilateral medial malleolus bilaterally (cm) via tape 
measure, and knee and ankle joint widths (cm) via a caliper. After 
collection of this data is completed and recorded, the PI will place 
reflective markers on the patient’s skin via adhesive tape made for 
this purpose at the following landmarks bilaterally: ASIS, posterior 
superior iliac spine, lateral thigh, knee center of rotation, lateral leg, 
heel, lateral malleolus, and base of the second metatarsal. When this 
set-up is complete, static calibration of the motion analysis system 
will take place with the participant standing still in the capture area. 
When this is complete, the participant will be allowed a 2-minute 
warm-up by walking back and forth in the capture area. When this is 
completed the participant will be asked to walk at a comfortable pace 
across the capture area. Three trials with good force plate contact 
will be collected. After these three trials are obtained, the patient will 
lie supine on the mat in the lab, and will be taught how to perform a 
TA contraction. A Pathway MR-20 biofeedback device (The 
Prometheus Group, Dover, NH, USA) with two electrodes will be 
placed just medial to the ASISs on the participant’s abdomen. A 
baseline maximal contraction will be performed supine, and the 
amplitude of contraction will be considered maximal voluntary 
isometric contraction (MVIC). The device will be set to provide 
audible feedback at 50% MVIC. The task will be repeated seated, 
standing, then ambulating three practice trials on the capture area. 
The participant will then be instructed to perform an additional three 
comfortable paced ambulation trials with good force plate contact 
while contracting the TA enough to cause audible feedback via the 
biofeedback device. After completing these three trials, the 
biofeedback device and reflective markers will be removed, and the 
participant will have completed their active participation in the 
study. 
9.3  
Procedure/Test 
Rate of Occurrence 
Anthropometric Data Collection 
1 
Reflective Marker Placement 
1 
Biofeedback Placement 
1 
TA Contraction Trials with 
Biofeedback 
At least once per body 
position 
Walking Trials without TA 
Contraction 
3 
Walking Trials with TA Contraction 
3 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 7 of 12 
 
 
Exclusion criteria prevent participation of those who require 
assistance or assistive devices for ambulation, so safety during 
ambulation is thus minimized. The adhesive tape used in 
placement of the reflective markers is intended for placement 
on skin. In regards to PHI, the PI will be the only investigator 
involved in recruitment, informed consent, and collection of 
anthropometric data. All documentation of these aspects of the 
study will be kept in the PI’s office in a drawer, with both the 
office and drawer able to be locked. The motion analysis data 
will be stored and analyzed on the computer in the Motion 
Analysis Laboratory under password protection, with the lab 
able to be locked. 
 
A tape measure, body weight scale, Pathway MR-20 
biofeedback device (The Prometheus Group, Dover, NH, USA) 
with two electrodes, and Vicon Vero 2.2 Motion Analysis 
System will be used. 
 
Please see that attached Excel worksheet that will be used on 
data collection. 
9.4 There is no long-term follow up for this study. 
9.5 NA 
10.0 Data and Specimen Banking* 
10.1 Data banking will be performed at the conclusion of this study in 
order to use for research or post-hoc power analysis. The repository 
will consist of the digital data collected during the study. Data will 
be stored for a period of three years, and may only be accessed via 
password through the computer in the Motion Analysis Laboratory. 
Only the PI will have access to this data, and will only use the data 
with additional IRB approval of a new protocol. Anyone else 
wishing to use the data must first ask the PI permission before 
initiating a new protocol. 
10.2 Data to be stored is the raw digital data (kinetic and kinematic) and 
analyzed (T1) collected during motion analysis.  
10.3 The PI, or another researcher after first asking permission of the PI, 
will have to submit an application to the IRB before using the stored 
data for any research purposes. After IRB approval of a new 
protocol, the password for the computer will be provided, and the 
researcher will have access to the raw data only. They will be 
responsible for any analysis that may be required for new variables. 
11.0 Data Management* and Confidentiality 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 8 of 12 
 
11.1 The three trials without and with TA contraction during ambulation 
will be analyzed to determine T1 for each trial. The average of the 
three trials under each condition will be calculated. Statistical 
analysis will include a repeated measures, two mean comparison (a 
paired-samples t-test or Wilcoxon signed rank depending on results 
of assumption analysis). Statistical analysis will be performed using 
the most up to date version of SPSS available to the PI. 
11.2 The study is serving as a pilot study for post-hoc power analyses of 
the variables under consideration for future study. 
11.3 The computer, which stores and analyses the raw kinetic data, is 
password protected. Only the PI and the faculty member in charge of 
the lab have the password. In addition, only the faculty of the SAHP 
has access to the lab via key entry. All participants will be given a 
code-identifier, with a key kept in the compliance binder for the 
study (also containing informed consent documentation). This 
compliance binder will stay in the PI’s office in a locked drawer.  
11.4 Once the raw data is saved on the computer, the files will be backed 
up on a flash drive which will also be kept in a locked drawer in the 
PI’s office. 
11.5  
 
Data will be stored on the computer in the motion lab, and 
analyzed data will be backed up on a flash drive locked and 
stored in the PI’s office drawer. 
 
Data will be stored for three years per the data banking 
procedure noted in section 10.1-10.3. 
 
See 10.1-10.3 for persons having access to the data. 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
12.1 NA; pending the IRB agrees with the PI there is no more than 
minimal risk to participants in this research protocol. 
13.0 Withdrawal of Subjects* 
13.1 The PI does not anticipate any circumstances where a participant 
may wish to withdraw since this study only requires a very short-
term in-person participation. However, if after data collection a 
participant contacts the PI wishing to not be included in any data 
analysis/publication, their data will be withdrawn from analysis. 
13.2 As soon as a participant informs the PI they wish to withdraw, a 
notation will be made in the compliance binder, and their data will 
not be analyzed upon data analysis. 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 9 of 12 
 
13.3 Due to the brief nature of participation and data collection, anyone 
who withdrawals from the study cannot be used for data analysis. 
14.0 Risks to Subjects* 
14.1 The only foreseeable discomfort a participant may have is some 
muscle soreness within 48 hours from the ambulation and TA 
muscle contractions involved. Also, there is a possibility of the 
adhesive tape pulling any hair present on the skin when removed.  
14.2 NA 
14.3 NA 
14.4 NA 
15.0 Potential Benefits to Subjects* 
15.1 There is a possibility of the research concluding that core 
stabilization may be beneficial to this population. If that is the case, 
the PI could communicate this to the participants in order for them to 
use this in their decision making when is comes to rehabilitative 
interventions they may undergo in the future. 
15.2 There is no direct benefit for participation, only indirect for future 
use by the patient in their future rehabilitative decisions. 
16.0 Vulnerable Populations*: NA 
 
17.0 Community-Based Participatory Research* 
17.1 NA 
18.0 Sharing of Results with Subjects* 
18.1 The results of the study will be shared with participants after their 
participation if they indicate after questioning to the affirmative after 
data collection is complete. The results will be shared via a mail out 
from the PI after completion of the study. 
19.0 Setting 
19.1 All recruitment, informed consent, data collection, and data analysis 
will be completed in the SAHP at LSUHSC-Shreveport. Data 
collection will be performed in the Motion Analysis Laboratory in 
the SAHP.  
20.0 Resources Available 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 10 of 12 
 
20.1 The PI is a licensed physical therapist specializing in orthopaedics. 
The PI has training in motion analysis. A professor from another 
physical therapy at Texas Woman’s University (TWU) in Houston 
will be present to assist with working the Vicon System in order to 
facilitate data collection and train the PI on data analysis of the raw 
data. The visiting professor is a tenure associate professor at TWU 
who has published in the area of motion analysis in PT in the past.  
20.2  
 
The Rehabilitation Faculty Practice Clinic treats many patients 
with knee OA, and has treated many in the past. There are 
dozens of potential applicants the PI has access to through the 
clinic. It is more feasible to recruit this small sample size in a 
short period of time due to the nature of this particular study. 
 
The PI has a faculty contract which allows for 30% effort 
towards research/scholarship. During the time this study is 
ongoing, 2/3 of this time will be devoted completely to this 
project. 
 
The Motion Analysis Laboratory is located on the second floor 
(room 2-217) in the SAHP. The lab is 700 square feet, and has 
a Vicon Vero 2.2 (8 camera) motion analysis system with 2 
AMTI force plates embedded in the raised platform (8 x 24 ft). 
There are two desktop monitors connected to the computers 
used for data collection and analysis for viewing of output and 
processing.  
 
The PI is the author of the protocol, and the only full-time 
investigator. 
21.0 Prior Approvals 
21.1 NA 
22.0 Recruitment Methods 
22.1 Participants will be recruited either in person or via phone call. The 
PI will speak with other clinicians in the Rehab Faculty Clinic as to 
whether they know any patients who may fit the selection criteria. In 
addition, the PI will do a chart review in TherapySource in order to 
find any past patients who fit the criteria. Once someone is 
identified, the PI will use his or still a current patient in the clinic, 
the PI will approach him or her in person at his or her next scheduled 
visit. 
22.2 The subjects will be recrtuied from current and past patients in the 
SAHP Rehab Faculty Clinic. 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 11 of 12 
 
22.3 TherapySource, the documentation system in the clinic, will be 
reviewed for patients who fit the criteria, in addition to speaking 
with other therapists in the clinic. 
22.4 NA 
22.5 NA 
23.0 Local Number of Subjects 
23.1 Three to five participants will be recruited for the purposes of this 
pilot study. 
23.2 NA 
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 The participants will only interact with the PI directly during both 
the informed consent process and in data collection. The visiting 
professor who will be working the motion system will be present in 
the room during data collection; however, the PI will be performing 
all instruction, data collection, and leading the investigation. 
24.2 The PI will have already met all the participants during informed 
consent, and may even be familiar with him from their time 
receiving treatment in the clinic. In addition, the lab is located two 
floors above the clinic, and is a private setting, so there is a reduced 
risk of them being observed by anyone not participating in the 
research. 
24.3 The PI is able to access any information at any time since he is 
protecting all the hardcopy and digital data. No one else will be able 
to access the information.  
25.0 Compensation for Research-Related Injury 
25.1 NA; pending the IRB agrees with the PI there is no more than 
minimal risk involved.  
25.2 NA; pending the IRB agrees with the PI there is no more than 
minimal risk involved.  
26.0 Economic Burden to Subjects 
26.1 Other than the cost of transportation, there will be no costs incurred 
by participation in the study. 
27.0 Consent Process 
27.1  

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE: The Effect of Volitional Transversus Abdominis Contraction on 
Time to Peak Sagittal Ground Reaction Force during Gait in Patients with Knee 
Osteoarthritis 
 
 
Page 12 of 12 
 
Informed consent will take place in the Rehabilitation Faculty Practice 
Clinic in the SAHP. 
 
Informed consent will take place on a separate day from data 
collection; therefore, there will be a waiting period between 
consent and participation. 
 
Upon presenting to the lab for participation in data collection, 
the PI will verify verbally with the participant they still wish to 
participate. It will be the participant’s responsibility to contact 
the PI after participation is complete in order to withdraw from 
data analysis. 
 
The PI will be the sole obtainer of informed consent, and will 
follow SOP. 
Non-English Speaking Subjects 
 
NA; due to the brief nature of the study, the PI will not recruit 
those who cannot speak and understand English 
 
28.0 Process to Document Consent in Writing 
28.1 The PI will be following the SOP of informed consent set by the 
LSUHSC-Shreveport IRB. 
29.0 Drugs or Devices 
29.1 NA 
29.2 NA