The Effects of Core Activation and Stabilization Training on Gait Kinetics, Kinematics, and Speed, and Self-Perceived Function 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 Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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PROTOCOL TITLE: 
The Effects of Core Activation and Stabilization Training on Gait Kinetics, 
Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
PRINCIPAL INVESTIGATOR: 
Daniel Flowers, PT, DPT 
Assistant Professor 
Department of Rehabilitation Sciences, Program in Physical Therapy 
318-813-2958 
dflowe@lsuhsc.edu 
VERSION NUMBER: 
4 
DATE: 
Initial submission of Version 1: 10/12/18 
Modifications submitted of Version 2: 12/3/18 
Modifications submitted of Version 3: 1/29/19 
Modifications submitted of Version 4: 7/26/19 
 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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Table of Contents 
1.0 
Objectives* .............................................................................................................. 3 
2.0 
Background* ............................................................................................................ 4 
3.0 
Inclusion and Exclusion Criteria* ............................................................................ 6 
4.0 
Study-Wide Number of Subjects* ........................................................................... 7 
5.0 
Study-Wide Recruitment Methods* ........................................................................ 7 
6.0 
Multi-Site Research* ............................................................................................... 7 
7.0 
Study Timelines* ..................................................................................................... 8 
8.0 
Study Endpoints* ..................................................................................................... 8 
9.0 
Procedures Involved*............................................................................................... 8 
10.0 Data and Specimen Banking* ................................................................................ 12 
11.0 Data Management* ................................................................................................ 13 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* ........................ 14 
13.0 Withdrawal of Subjects* ........................................................................................ 15 
14.0 Risks to Subjects* .................................................................................................. 15 
15.0 Potential Benefits to Subjects* .............................................................................. 15 
16.0 Vulnerable Populations* ........................................................................................ 16 
17.0 Community-Based Participatory Research* .......................................................... 16 
18.0 Sharing of Results with Subjects* ......................................................................... 16 
19.0 Setting .................................................................................................................... 16 
20.0 Resources Available............................................................................................... 16 
21.0 Prior Approvals ...................................................................................................... 17 
22.0 Recruitment Methods ............................................................................................. 17 
23.0 Local Number of Subjects ..................................................................................... 18 
24.0 Confidentiality ........................................................ Error! Bookmark not defined. 
25.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 19 
26.0 Compensation for Research-Related Injury ........................................................... 19 
27.0 Economic Burden to Subjects ................................................................................ 19 
28.0 Consent Process ..................................................................................................... 19 
29.0 Process to Document Consent in Writing .............................................................. 19 
30.0 Drugs or Devices.................................................................................................... 20 
 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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1.0 
Objectives* 
1.1 The purpose of this investigation is to determine the effect, if any, 
core activation and stabilization training may have on the gait and 
function of patients diagnosed with knee osteoarthritis (KOA).  
The specific aims of this investigation include: 
Specific Aim 1: Determine if kinetic (time to first peak ground 
reaction force [T1] and second peak ground reaction force [F2], both 
in the sagittal plane, and external knee adduction moment [KAM]) 
and kinematic (peak stance knee flexion angle [KFA]) gait variables, 
and speed, differ between patients with KOA and age and gender 
matched controls during self-selected paced ambulation, and 
determine which ones have predictive relationships with Knee Injury 
and Osteoarthritis Outcome Score (KOOS) scores in the patients 
with KOA. 
Specific Aim 2: Determine if volitional core activation alters gait 
kinetics (T1, F2, and KAM), kinematics (KFA), and speed in patients 
with and without KOA during self-selected paced ambulation when 
compared to ambulating without volitional core activation, and 
whether the subjective pain complaints are significantly changed in 
the group with KOA. Determine whether there are baseline 
differences in core activation between those with and without KOA.  
Specific Aim 3: Determine if a six-week core stabilization program 
alters KOOS score, and the kinetics (T1, F2, and KAM), kinematics 
(KFA), and speed of gait in patients with KOA during self-selected 
paced ambulation as compared to their pre-intervention baselines. 
Determine if there is a predictive relationship between the number of 
completed intervention sessions performed and these observed 
changes. 
1.2 The alternate hypotheses for each specific aim include the following: 
Specific Aim 1: 
H1: Participants with KOA will have significant differences in 
lower extremity kinetics (T1, F2, and KAM) and kinematics (KFA), 
and gait speed, as compared to healthy controls during self-
selected paced ambulation.  
 
H2: The significant kinetic (T1, F2, and KAM), kinematic (KFA), 
and gait speed differences observed in participants with KOA will 
have a significant predictive relationship to their scores on the 
KOOS. 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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Specific Aim 2: 
H1: Gait speed, kinetics (T1, F2, and KAM) and kinematics (KFA) 
will significantly differ with volitional activation of the core during 
self-selected paced ambulation within the KOA group and between 
the KOA and control groups.  
 
H2: Pain, as assessed via a Numeric Pain Rating Scale (NPRS), 
will significantly differ from baseline with volitional activation of 
the core during self-selected paced ambulation for patients with 
KOA. 
 
H3: There will be a significant difference in the baseline transversus 
abdominis (TA) activation observed via electromyography (EMG) 
analysis between and within the control and KOA groups, without and 
with volitional activation during ambulation. 
Specific Aim 3: 
H1: Gait speed, kinetics (T1, F2, and KAM), and kinematics (KFA) 
will significantly differ in participants with KOA during self-
selected paced ambulation after a six-week core stabilization 
program when compared to their baseline.  
 
H2: Functional ability, as assessed via the KOOS, will significantly 
differ in participants with KOA from baseline after a six-week core 
stabilization program. 
 
 
 
H3: The total number of supervised and home exercise sessions in a six-
week intervention program will significantly predict changes in gait speed, 
kinetics (T1, F2, and KAM), and kinematics (KFA) in participants with 
KOA during self-selected paced ambulation. 
 
2.0 
Background* 
2.1 This will be the second investigation by the PI and sub-investigator 
on this topic, following the promising results of a pilot study on a 
small sample size (N=5) completed last year. Whether or not core 
stabilization influences gait impairments in patients with KOA 
remains to be seen. Core stabilization has been shown to have 
positive effects, including increased stride velocity and scores on 
functional tests like the Functional Reach Test and Timed Up and 
Go, in older adults.1 Older adults were also shown to have high 
compliance with a core stability training program.1 A systematic 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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review indicated that core training is important to consider when 
treating older individuals to improve functional use of the 
extremities, improving participation in activities of daily living, and 
as part of a fall prevention program.2 Additionally, it has been shown 
to benefit young, active individuals in preventing anterior cruciate 
ligament injury3 and greater duration of improved outcomes in 
patients with patellofemoral pain syndrome.4 Athletes with 
decreased core control have been shown to be at an increased risk of 
knee injury as well.5 One potential cause for this is the ability of the 
core to improve lower extremity kinematics when activated during 
challenging single leg weight bearing activity.6 A recent publication 
by Azuma, et al. did indicate that paraspinal and anterior abdominal 
thinning had a negative predictive relationship to the presence of 
KOA;7 however, no investigation has explored a cause and effect 
relationship between core stability/stabilization training and the 
presence or severity of KOA, nor the gait and functional ability of 
patients with KOA. This later concept is the focus of this 
investigation. 
2.2 Unpublished pilot data (see 2.1) collected by the same PI and sub-
investigator shows that volitional activation of the TA during self-
selected paced ambulation significantly decreases the time to first 
peak ground reaction force (T1) in the sagittal plane in participants 
with KOA (D.W. Flowers, C. Frilot, unpublished data, May 2018). 
This same kinetic gait variable is included in this investigation as 
one of the dependent variables in all three parts of the investigation.  
2.3 Nearly four percent of the global population has KOA, with the 
global female percentage nearing five percent. Additionally, the 
years lived with disability (YLDs) resulting from the disorder 
increased by 64.8% from 1990 to 2010.8 The picture is not much 
better in the United States, where osteoarthritis ranks eighth highest 
in YLDs compared to other pathologies.9 The rate of KOA has 
continued to climb here in the U.S., doubling in the past half-century 
even when accounting for increased life expectancy and higher 
average BMI,10 both of which are considered risk factors in the 
development of KOA.11  
Patients with KOA have been shown to have gait abnormalities 
when compared to healthy controls, including alterations in trunk 
and pelvic kinematics,12 lower extremity kinematics13,14  and 
kinetics,14-18  gait speed,13-17,19  and functional outcome measure 
scores.19  Some of these differences, like an increased external knee 
adduction moment (KAM)20,21 and a decreased peak stance knee 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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flexion angle (KFA),14 have been shown to correlate with the 
advancement of KOA and may be causative in nature. Others, like an 
increased T116 and reduced freely chosen gait speed,22 may be 
compensatory.23 The same has been found in regard to the reduced 
second peak ground reaction force in the sagittal plane (F2) observed 
in this population.18  
Reduced gait speed alone is predictive of increased fall risk in older 
adults, without any need to consider additional activities performed 
during walking tasks.24  Additionally, the gait impairments observed 
in this population can be so extreme that they can be more limiting 
than those observed in patients with diagnoses typically considered 
more severe, like congestive heart failure, diabetes, heart disease, 
and stroke.25 Therefore, improving function via improving gait speed 
via novel approaches is indicated, but not at the expense of 
increasing wear and tear on osteoarthritic joints. This investigation 
aims to show that core stabilization, which has been shown 
beneficially influence the kinetics and kinematics of lower extremity 
movements in younger, more active populations, can serve the same 
purpose in a population with KOA. The investigators are specifically 
trying to improve self-perceived function and gait speed, via 
improving the kinetics and kinematics observed in self-selected 
ambulation.  
3.0 
Inclusion and Exclusion Criteria* 
3.1 Potential participants will be screened for eligibility by the PI once 
they have expressed interest either by contacting the PI themselves, 
or upon being referred by someone familiar with the investigation. 
Assurance of meeting the inclusion and exclusion criteria will be 
ensured during the informed consent process.  
3.2 The inclusion and exclusion criteria for this investigation are as 
follows: 
Inclusion criteria: 
English-speaking men and women, 40 years old and older, of any 
race or ethnic group, with a documented diagnosis from a medical 
provider (i.e., physician, physician assistant, or nurse practitioner, 
etc.) of KOA, unilaterally or bilaterally. Previous or current physical 
therapy patients may be included (see exclusion criteria for 
exceptions). Healthy controls will meet the same requirements, but 
without a medical diagnosis of KOA and have the ability to ambulate 
on a level surface without any report of pain in their knees at the 
time of gait assessment.  

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
Page 7 of 23 
 
 
Exclusion criteria: those with other lower extremity injuries 
(orthopaedic, cardiovascular, neurologic, etc.) which are currently 
hindering their ability to ambulate, those with current complaints of 
low back pain, those who have undergone bilateral total knee 
arthroplasty, those with concomitant diagnosis of rheumatoid 
arthritis, those persons not able to ambulate independently with or 
without an assistive device, those who have received a corticosteroid 
injection within the past two months, those who have received a 
hyaluronic acid injection in the past six months, and those persons 
currently enrolled in a core training program as part of formal 
physical therapy or physical fitness.  
3.3 Special populations will not be included in this investigation for the 
following reasons: 
Adults unable to consent, individuals who are not yet adults, 
pregnant women, and prisoners will not be included in this 
investigation. Adults unable to consent will not be included since 
following directions and participating in an intervention program 
with active participation will be required. Minors will not be 
included since they do not meet the inclusion criterion for age (>/= 
40 years old). Pregnant women will not be included since many of 
the core exercises would need to be adapted in order to safely 
prescribe exercises tailored to that population, in addition to certain 
core contractions being contraindicated. Prisoners will not be 
included since they would not be able to attend all the intervention 
sessions.  
4.0 
Study-Wide Number of Subjects* 
4.1 NA. 
5.0 
Study-Wide Recruitment Methods* 
5.1 NA.  
5.2 NA.  
5.3 NA.  
6.0 
Multi-Site Research* 
6.1 NA. 
6.2 NA.  
6.3 NA.  

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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7.0 
Study Timelines* 
7.1 Each participant with KOA will actively participate in the study 
eight weeks, depending on the participants scheduling abilities. This 
will require 10-12 hours total of participation. Participants in the 
control group are the exception, as they will only be required to 
attend one session for full participation. This single session will last 
about 1-2 hours. It is anticipated that it will take approximately 12-
18 months to enroll all study participants, with completion of data 
collection/analyses within this same timeline.  
8.0 
Study Endpoints* 
8.1 The primary endpoint of this investigation will be the completion of 
all data collection, with all participants in both the control and 
experimental groups having concluded their participation.  
The secondary endpoint will be the completion of all data analysis, 
and preparation for dissemination of the research findings.  
8.2 NA. 
9.0 
Procedures Involved* 
9.1 This investigation will be divided into three parts, each associated 
with one of the specific aims detailed in Section 1. All procedures 
will be performed in the School of Allied Health Professions, either 
in the Motion Analysis Laboratory (Gait Lab) or the Rehabilitation 
Faculty Practice (RFP) Clinic.  
Part 1: Compare age and gender matched healthy controls and KOA 
groups on kinetics, kinematics, and gait speed during self-selected 
speed via a between groups analysis across the dependent variables, 
and determine if those differences in the KOA group have a 
predictive relationship with their KOOS scores. 
Part 2: Within-group comparison of both groups (with and without 
volitional TA activation) and between-groups (control group versus 
KOA group). Compare pain levels during both conditions via NPRS 
for the KOA group. Participants will wear biofeedback under both 
conditions, and all condition trials will be randomized. Alarm or 
verbal cue will be provided at 30% MVIC, and two electrodes placed 
over TA/obliquus internus (OI) just medial to anterior superior iliac 
spine (ASIS). A comparison of TA activation will be performed both 
within and between groups.  
Part 3: Within-groups comparison of KOA group (pre-treatment and 
post-treatment; six-week training program) on kinetics, kinematics, 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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and gait speed during self-selected paced ambulation. A comparison 
of KOOS scores before and after treatment with be performed as 
well.  
9.2 Once recruitment (see 22.0) and informed consent (see 27.0 and 
28.0) are completed: 
Part 1: All participants will undergo anthropometric data collection 
first, including weight, height, leg length, knee joint width, and ankle 
joint width. Age matching will be done within +/- 5 years between 
the two groups. Reflective markers will then be placed on bilateral 
lower extremities following the Plug in Gait Model. EMG electrodes 
will be placed bilaterally just medial to the ASIS, over the TA/OI. 
The Gait Lab will undergo calibration, and the participant will 
undergo a static trial. In participants with bilateral KOA, the most 
painful limb, identified by subjective report, will be used in the data 
collection procedures. Healthy controls will undergo analysis of their 
dominant limb by indicating with which leg they would kick a ball. 
Once the set-up and calibration are completed, the data collection 
will begin. The participant will be allowed a brief warm-up of 1-2 
minutes, walking in the Gait Lab prior to data collection commences. 
The participant will then be asked to walk at a self-selected pace 
across the capture area until three trials with good force plate contact 
are obtained. Good force plate contact is defined as initial contact at 
the heel and pre-swing/toe off occurring on the force plate, and the 
absence of any evidence of distraction via the video cameras, such as 
the participant talking or looking around the lab. These three trials 
will be used in the kinetic, kinematic, and gait speed data analysis.  
See Part 2 for additional trials that will be performed concurrently 
for both groups. Participants in the experimental group will also be 
asked to complete a KOOS questionnaire at the same time.  
Part 2: Participants will undergo the same procedures described in 
Part 1 above. While the three trials are obtained for Part 1, three 
additional walking trials will be concurrently collected for the both 
groups. These will include the participant volitionally activating 
their TA during the walking trials, performed and screened exactly 
the same as in Part 1. These trials will be performed with and 
without audible biofeedback (via an alarm or verbal cueing), 
indicating the TA meeting the threshold subsequently discussed 
below. Investigators will randomly determine whether the trials with 
or without volitional TA activation are performed first (i.e., Part 1 
versus Part 2 trials). The randomization done for Part 2 to determine 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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whether or not the without (Part 1) or with (Part 2) volitional TA 
activation trials are performed first will be determined via random 
number generation between 0 and 1 in Excel. Those with 0 will 
perform the without volitional TA (Part 1) trials first, while those 
with 1 will perform the with volitional TA activation trials (Part 2) 
first.  
 
The patient will lie supine on the mat in the lab and will be taught 
how to perform a TA contraction. Please see the attached script with 
the instructions that will be used in this education. 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, or the participant will receive a verbal cue from the 
investigator, at 30% MVIC. This feedback will be randomized 
throughout the trials with TA activation via random number 
generation in Excel, with 0 signifying no cue and 1 indicating a cue. 
The task will be repeated seated, then standing, prior to data 
collection.  
 
The experimental group, during both sets of trials, will be asked to 
subjectively rate their perceived pain in the lower extremity being 
used in data collection via a 10-point scale, typically used on the 
NPRS, although no visual will be used. Please see the supplemental 
script document attached to this protocol for the instructions used.  
Part 3: Participants in the experimental group will participate in a 
six-week core stabilization intervention program. Please see the 
attached intervention program. This program will commence as soon 
as possible after Parts 1 and 2 of the investigation are completed. 
Participants will participate in two scheduled intervention sessions 
each week. Additionally, there will be a home exercise program, 
consisting of exercises from each week to be performed at home 
independently. Participants will be provided education and a handout 
on these exercises by the PI, which will include directions, 
photographs of the exercises, and a completion check-off for each 
session. These will be performed three times per week, every other 
day. The PI will be coordinator of the scheduling and performance of 
these interventions. These intervention sessions will be performed in 
the RFP Clinic in the SAHP, either in the open gym or in a private 
treatment room. This decision will be left up to the participant. More 
than one participant may or may not undergo intervention with the PI 
simultaneously, but only with the participants’ consent. No more 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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than three participants will undergo the training simultaneously. 
Training sessions will not be performed on consecutive days in an 
effort to reduce the chances of delayed onset muscle soreness being 
present during treatment sessions. Additionally, the core training 
program includes predetermined guidelines on exercise progressions 
in order to ensure that the exercises are not progressed too rapidly. 
The PI will be present and will lead all sessions, ensuring that the 
exercises and their progressions are done correctly.  
After the completion of the intervention program, each participant 
will undergo gait analysis in the same manner mentioned in Part 1, 
with the exception of no anthropometric data being collected. 
Participants will then complete a second, post-intervention KOOS 
questionnaire, and turn in their home exercise program sheet with 
tallies from completed sessions. Please see Part 1 for completion of 
the pre-intervention KOOS questionnaire.  
9.3 The table below details the procedures and occurrence of those 
procedures throughout a single participant’s participation in the 
investigation: 
Procedures 
Occurrence 
Education/Informed Consent 
1 all participants 
Anthropometric Data Collection 
1 all participants 
Baseline (Part 1) 
Without & With Core Activation (Part 2) 
Pre 6-Week Intervention Gait & EMG Assessment (Part 3) 
1 all participants 
(except no part 3 
for controls) 
Pain NPRS Assessment 
2 for KOA group 
Core Stability Intervention Program 
12 sessions, plus 18 
home program 
sessions (KOA 
group only) 
Post 6-Week Intervention Gait & EMG Assessment 
1 (KOA group only) 
Pre and Post 6-Week Intervention KOOS Assessment 
2 (KOA group only) 
 
9.4 The exclusion criteria serve to prevent participation of those who 
require assistance or assistive devices for ambulation, so safety 
during the ambulation activities is minimized. The adhesive tape 
used in reflective marker placement is intended for placement on the 
skin. Regarding PHI, the PI will be the only investigator involved in 
the recruitment and consent process and will be charged with 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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protecting the PHI in his office. The motion analysis data and PHI 
will be protected in the manner discussed in sections 11.3.  
A tape measure, body weight scale, EMG biofeedback with 
electrodes, and Vicon Vero 2.2 Motion Analysis System, and 
reflective markers with tape will be used. Exercise equipment will 
include exercise mats/high-low exercise tables, ankle weights, hand 
weights, BOSU balls, and resistance bands.  
Please see the attached Excel file that will be used for data 
collection, in addition to the script for instructions to patients and 
KOOS questionnaire. 
9.5 There is no long-term follow-up for this study apart from the final 
data collection session for the experimental group after completing 
the six-week intervention. This session will include another motion 
analysis session and post-treatment KOOS questionnaire completion. 
9.6 NA. 
10.0 Data and Specimen Banking* 
10.1 A repository will be used to store all of the gait kinetic, kinematic, 
and speed data collected during the motion analysis sessions. This 
data will be stored on the computer system in the Gait Lab which is 
password protected, in addition to the lab itself being key access. 
The Data Collection Form (see attached), in addition to completed 
Core Program Tracker for Investigator Use and KOOS forms (see 
attached) will be included in the repository. This data will be kept in 
the PI’s office which is key access, with the Data Collection Form 
staying on the PI’s password protected personal laptop or state 
desktop computer, with the hardcopy KOOS and Core Program 
Tracker for Investigator Use forms will remain in the hardcopy 
compliance binders. The data will be stored for a period of seven 
years. Persons using the Gait Lab will have access to this data but 
will require IRB approval for use in research activities.  
10.2 The repository data will include all force plate data and that collected 
from the infrared cameras, including pelvis, hip, knee, and ankle 
joint moments, range of motion in all three planes, and 
spatiotemporal gait characteristics, in addition to anthropometric 
data, KOOS scores, pain NPRS ratings, and exercise data from the 
Core Program Tracker for Investigator Use form.  
10.3 In order for the data to be accessed for research purposes, a new 
approved IRB protocol will be required. Additionally, if the author 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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of said protocol is not the PI or the sub-investigator, they will need 
to request permission from one of these investigators prior to 
including this request in their proposed research protocol. 
11.0 Data Management* and Confidentiality 
11.1 Data analysis will be performed by the PI, with the assistance of the 
sub-investigator. The PI will use the latest version of SPSS available 
to the PI on his personal laptop computer (see 11.3 for security 
details). The kinetic, kinematic, and speed data will be analyzed 
together, either by a MANOVA (if assumptions are met) or separate 
ANOVA/mean comparison analyses with Bonferroni corrections, 
while the pain NPRS and KOOS scores will be analyzed each 
individually via means comparisons. The EMG data will be analyzed 
via a 2x2 ANOVA or separate means comparisons. If the groups 
have significantly different mean BMIs, then it will be included in 
the kinetic and kinematic analysis as a covariate. The predictive 
relationship between the number of exercise sessions and the change 
observed within the KOA group for each variable will be analyzed 
via regression analysis. 
11.2 An a priori power analysis was performed to determine the number 
of participants required to achieve significance for the variables of 
highest interest in the investigation. Data from previous publications 
on these variables were used in the power analysis. These include the 
following: T1 between16 and within (D.W. Flowers, C. Frilot, 
unpublished data, May 2018) groups, F2 between and within 
groups,18 KAM between and within groups,17 KFA between14 and 
within26  groups, and gait speed between16 and within27 groups for 
the kinetic and kinematic analyses. Additionally, the KOOS28 was 
examined for within-group means comparison. The PI used 
G*Power (Heinrich-Heine-University Düsseldorf, Düsseldorf, 
Germany) for the purposes of these analyses. It was determined that 
45 participants would be required, except for the KFA which would 
require a larger sample size. Since this variable will be collected 
concurrently along with the other kinetic and kinematic data, and all 
the other variables of interest are appropriately powered at a much 
lower sample size, we felt confident proceeding regardless of being 
underpowered for one of these five dependent kinetic/kinematic 
variables of interest.  
Since this study involves a six-week intervention, an attrition rate of 
10% was assumed, so a total of 50 participants (25 healthy controls 
and 25 with KOA) will be recruited. Data analysis will be completed 

HRP-503 (v.6.1.2016) 
 
PROTOCOL TITLE:  The Effects of Core Activation and Stabilization Training on Gait 
Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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intermittently throughout data collection, and if significance is 
achieved prior to 50 participants completing their participation, 
recruitment will be discontinued, and only those in the study will be 
allowed to complete the study. This will be done in an effort to 
reduce the number of people undergoing this less than minimal risk 
investigation.  
11.3 The kinetic and kinematic data will be stored on the computer 
system in the Gait Lab. This lab is key accessible by the faculty of 
the SAHP. The computer system is password protected, with the PI 
and the sub-investigator being the only two individuals who 
currently know that password. Other faculty members would need to 
get the password from these two investigators for their own research 
activities unrelated to this investigation. The data will be backed up 
on an external hard drive belonging to the two investigators. No 
personal identifying information will be included in this data, as the 
participants will be identified by their participant identification 
numbers. The key to these identifiers will be the signed consent 
forms maintained by the PI that have both the participants’ names 
and identification number on them. These forms will be maintained 
in the PI’s office (SAHP Rm 2-234) which is key access, in a 
compliance binder. The data collection forms and KOOS 
questionnaires will also be located in this binder, with only the 
identification number on them. All of the deidentified raw data, 
including kinetic, kinematic, gait speed, NPRS ratings, and KOOS 
scores will also be maintained on the PI’s personal laptop and work 
desktop computers for the purposes of data analysis, and 
preparations for dissemination after the completion of the data 
collection and analysis. Both of these computers are password 
protected. This de-identified data will be backed-up on the PI’s 
personal flash drives.  
11.4 The PI and/or the sub-investigator will be performing a calibration of 
the motion analysis system prior to each data collection session, 
thereby reducing the risk of errors in the data from loss of calibration 
over time. EMG calibration and set-up will be completed by the sub-
investigator. Additionally, the PI will be providing the same 
instructions on the core activations and pain NPRS reporting 
performed during Part 2 of the investigation.  
11.5 See 11.3 regarding the mode and length of data storage, and who 
will have access to the data.  
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 

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12.1 NA; pending the IRB agreeing with the PI that there is no more than 
minimal risk to participants in this investigation. 
13.0 Withdrawal of Subjects* 
13.1 Participants in the experimental group will be withdrawn from 
participation without their consent if they miss more than four of the 
total 12 sessions throughout the entire intervention program. They 
will also be removed if they do not perform the home exercise 
program at least once a week. 
13.2 Immediately upon meeting the criteria for termination from 
participation, the participant will be informed in-person or by phone 
by the PI.  
13.3 If participants withdraw from the research, including partial 
withdrawal with some data collection having already been 
completed, data already collected will be used in data analysis, 
unless the participant specifically requests otherwise. Additionally, 
they will not participate in any further aspects of the investigation, 
after following the procedures from 13.1 and 13.2. The same will be 
done for participants who withdraw of their own volition. 
 
14.0 Risks to Subjects* 
14.1 The only foreseeable risk/discomfort a participant may have is some 
muscle soreness within 48 hours from the ambulation and TA 
muscle contractions involved in Part 2, or the same after 
participation in the core stability exercises included in Part 3. This 
soreness is considered a normal effect of muscular exercise. Also, 
there is a possibility of the adhesive tape, used during marker 
placement in the motion analysis data collection, 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 direct benefits to half of the participants 
(group with KOA) in Part 3 of the investigation, but no guarantee. 
This investigation focuses on a novel intervention to improve the 
gait and function of patients with KOA. Therefore, the purpose of 

HRP-503 (v.6.1.2016) 
 
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Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
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this investigation is whether or not this intervention will have direct 
beneficial effects.  
15.2 There is no possibility of a direct benefit, besides knowledge of 
current gait and functional ability for Parts 1 and 2 of this 
investigation; however, there is a possibility of direct benefit after 
participation in the core stability intervention program included in 
Part 3 if the program is found to improve gait and function in 
participants with KOA.  
16.0 Vulnerable Populations* 
16.1 NA. 
17.0 Community-Based Participatory Research* 
17.1 NA. 
18.0 Sharing of Results with Subjects* 
18.1 No individual participant results will be provided. Participants will 
be provided with the PI’s contact information if they wish to know 
the results of the investigation after their participation is completed, 
and data analysis is completed.  
 
19.0 Setting 
19.1 All recruitment, informed consent, data collection, and data analysis 
will be completed in the SAHP at LSU Health-Shreveport. Data 
collection will be performed in the Gait Lab in the SAHP. The 
intervention program will take place in the RFP Clinic in the SAHP. 
20.0 Resources Available 
20.1 The PI is a licensed physical therapist, with board-certification in 
orthopaedic physical therapy, and is a PhD candidate at Texas 
Woman’s University in the School of Physical Therapy. The PI has 
training in motion analysis. The sub-investigator has a PhD in 
Biomedical Engineering and is licensed as a Professional Engineer in 
Electrical Engineering. He also runs the Gait Lab in the SAHP. Both 
investigators are full-time faculty in the SAHP, the first as Assistant 
Professor and the later as Professor with tenure. 
20.2 Participants will be recruited from within the University and from 
outside sources in the greater Shreveport area. With KOA being so 
prevalent, the PI does not foresee any difficulty in recruiting the 
necessary sample size. Additionally, the recruitment methods 

HRP-503 (v.6.1.2016) 
 
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Kinetics, Kinematics, and Speed, and Self-Perceived Function in Patients with Knee 
Osteoarthritis 
 
 
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include assistance from other clinicians and departments, in addition 
to public advertising, enabling the PI to broaden the opportunities for 
recruitment (see 22.0). 
 
The PI has an FTE percentage of 30% dedicated to research in the 
LSU-Health Shreveport system, therefore up to 12 hours a week will 
be available for completing this project. This will be the only 
research project the PI is lead investigator on during the duration of 
this investigation. Additionally, the sub-investigator’s research FTE 
percentage is 40%, so he has up to 16 hours per week to devote to 
this project, among others.  
The Gait Lab 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 (12 
camera) motion analysis system with 2 AMTI force plates embedded 
in the raised platform (8 x 24 ft). The Gait Lab has an EMG system 
which is integrated with the motion analysis system, and will be used 
to collect the EMG data during the walking trials. There are two 
desktop monitors connected to the computers used for data 
collection and analysis for viewing of output and processing. The 
RFP Clinic is located on the ground floor of the SAHP and is a 
27,000 square foot facility with a large open gym area and private 
treatment rooms. 
 
The PI has designed the investigation, completed all of the IRB 
submission requirements, and pursued avenues for recruitment of 
participants; therefore, he is familiar with the protocol. The sub-
investigator has been informed and consulted throughout the 
process, and therefore has a good understanding of the purpose and 
specific aims of the study. He will be provided a copy of the protocol 
to review prior to commencement of the investigation.  
 
21.0 Prior Approvals 
21.1 Prior to commencing the research, approval of the study via an 
Institutional Authorization Agreement (IAA) with Texas Woman’s 
University in Houston (TWU) will be required since this 
investigation is being used in partial fulfillment of the PI’s PhD 
degree as the dissertation research. No data collection or recruitment 
will be done at this site.  
22.0 Recruitment Methods 

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22.1 Participant recruitment will start immediately after IRB approval is 
obtained, and the IAA is signed by TWU. All recruitment will be 
managed through LSU Health-Shreveport and will be focused in the 
Shreveport area. No recruitment will be done through TWU. 
Potential participants will be recruitment in multiple ways, including 
word of mouth, e-mailed flyers through the LSU Health-Shreveport 
Public Relations Department’s Friday flyer, e-flyer postings on the 
announcement TVs in the SAHP, e-flyers posted on social media 
(including Facebook), flyer placements in the RFP Clinic in the 
SAHP, hard-copy and EHR (TherapySource, Advanced MD, and 
EPIC) chart reviews in through the RFP Clinic in the SAHP, flyer 
postings throughout the community (ex. gyms, churches, etc.), and 
through coordination with departments in the Medical School and 
area physical therapy clinicians/clinics. The PI will request 
assistance from the Departments of Family Medicine, 
Rheumatology, and Orthopaedic Surgery, among any others 
identified, to identify potential participants, in addition to posting 
flyers. This will also include the Rehabilitation Sciences Department 
in Ochsner-LSU Hospital. This cooperation with other departments 
may also include chart reviews for each respective clinic in the EPIC 
system to screen for potential participants who may quality for the 
study prior to approaching them while in their clinic visits. The PI 
will also contact area therapists and therapy clinics asking them to do 
the same. If the PI does not recruit the participant in person, they will 
be contacted via telephone using the script attached to this protocol 
(see Telephone Script.v1.docx).  
22.2 Participants will be primarily those living in the Shreveport area, and 
may also include previous/current patients in the RFP Clinic. 
22.3 Once a potential participant expresses interest and contacts the PI, or 
once the PI contacts them, the PI will ensure they meet the 
inclusion/exclusion criteria. 
22.4 Both printed and e-versions of the same flyer will be used to recruit 
participants. Please see attached.  
22.5 NA. 
23.0 Local Number of Subjects 
23.1 Fifty participants (N = 50), 25 healthy controls and 25 with a 
diagnosis of KOA will be recruited for the purposes of this 
investigation.  
23.2 Refer to the a priori power analysis provided in section 11.2. 

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24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 During data collection procedures in the Gait Lab, no one other than 
the two investigators will be present without the participant’s 
consent. Additionally, during both the informed consent process and 
six-week intervention program, if the participant wishes to complete 
these activities in a private treatment room, this will be provided 
upon request. Participants will be required to inform the front desk 
they are present for research upon entering the RFP Clinic in the 
SAHP in order to be allowed into the clinic space during informed 
consent and intervention procedures but will not be required to 
provide additional information.  
24.2 See 24.1 regarding private treatment rooms, and limiting the number 
of persons present during data collection. 
24.3 If the participant is a previous/current patient in the RFP Clinic or 
University Health Clinics/Hospital, the PI will be able to access their 
medical record to obtain contact information during the recruitment 
process.  
25.0 Compensation for Research-Related Injury 
25.1 NA. This investigation does not involve any procedures greater than 
minimal risk to the participants. 
25.2 NA. See 25.1above. 
26.0 Economic Burden to Subjects 
26.1 Participants will be responsible for the cost of their own 
transportation to and from all research related activities. Otherwise, 
all aspects of the investigation will be provided at no cost to the 
participants, including the six-week core stabilization program 
including in Part 3 of the investigation.  
27.0 Consent Process 
27.1 All participants enrolled in this investigation will undergo informed 
consent following SOP: Informed Consent Process for Research 
(HRP-090). Informed consent will be performed in the RFP Clinic in 
the SAHP. Consent will typically be obtained immediately after 
informing the potential participant of all the procedures; however, 
they will have the option of a waiting period if they feel they need 
more time to make an informed decision prior to signature/consent.  
28.0 Process to Document Consent in Writing 

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28.1 This investigation will be following SOP: Written Documentation of 
Consent (HRP-091). 
28.2 The investigators plan on obtaining informed consent (see 28.3 
below), unless the IRB feels this investigation is exempt from such 
procedures.   
28.3 Informed consent will be documented in writing. Please see the 
attached informed consent document.  
29.0 Drugs or Devices 
29.1 NA. 
29.2 NA. 
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