Comparison of a Hip Activation Versus a Combined Hip Activation and Core Stabilization Program on Improving Lower Extremity Function: A Single-Blind Randomized Controlled Trial
Phase: NA
Conditions: Movement, Abnormal, Lower Extremity Problem
Sponsor: Louisiana State University Health Sciences Center Shreveport

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PROTOCOL TITLE: 
Comparison of a Hip Activation versus a Combined Hip Activation and Core Stabilization Program on 
Improving Lower Extremity Function. 
PRINCIPAL INVESTIGATOR: 
Daniel W. Flowers, PT, DPT, PhD 
Assistant Professor of Physical Therapy 
(318)-813-2958 
Daniel.flowers@lsuhs.edu 
VERSION NUMBER: 
1 
DATE: 
12/7/23 
 

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Table of Contents 
1.0 
Objectives* ...................................................................................................................................................3 
2.0 
Background* .................................................................................................................................................4 
3.0 
Inclusion and Exclusion Criteria* .................................................................................................................5 
4.0 
Study-Wide Number of Subjects* ................................................................................................................6 
5.0 
Study-Wide Recruitment Methods* .............................................................................................................6 
6.0 
Multi-Site Research* ....................................................................................................................................6 
7.0 
Study Timelines* ..........................................................................................................................................6 
8.0 
Study Endpoints* ..........................................................................................................................................6 
9.0 
Procedures Involved*....................................................................................................................................7 
10.0 Data and Specimen Banking* .......................................................................................................................9 
11.0 Data Management and Confidentiality* .....................................................................................................10 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* .............................................................11 
13.0 Withdrawal of Subjects* .............................................................................................................................11 
14.0 Risks to Subjects* .......................................................................................................................................11 
15.0 Potential Benefits to Subjects* ...................................................................................................................12 
16.0 Vulnerable Populations* .............................................................................................................................12 
17.0 Community-Based Participatory Research* ...............................................................................................12 
18.0 Sharing of Results with Subjects* ..............................................................................................................12 
19.0 Setting .........................................................................................................................................................12 
20.0 Resources Available....................................................................................................................................12 
21.0 Prior Approvals ...........................................................................................................................................13 
22.0 Recruitment Methods ..................................................................................................................................13 
23.0 Local Number of Subjects ..........................................................................................................................13 
24.0 Provisions to Protect the Privacy Interests of Subjects ...............................................................................13 
25.0 Compensation for Research-Related Injury ................................................................................................14 
26.0 Economic Burden to Subjects .....................................................................................................................14 
27.0 Consent Process ..........................................................................................................................................14 
28.0 Process to Document Consent in Writing ...................................................................................................14 
29.0 Drugs or Devices.........................................................................................................................................15 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0    Objectives* 
1.1 The purpose of this investigation is to compare the effects of a combined hip activation and 
core stabilization training home exercise program (HEP) versus a hip activation training 
HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.  
Specific Aim 1: To determine whether between- and/or within-group differences exist 
on the Forward Step-Down test (FSDT) when comparing a combined hip activation 
and core stabilization training HEP as compared to a hip activation training HEP.  
Specific Aim 2: To determine whether between- and/or within-group differences exist 
on the peak external knee abduction moment when comparing a combined hip 
activation and core stabilization training HEP to a hip activation training HEP.  
Specific Aim 3: To determine whether between- and/or within-group differences exist 
on gluteal and core muscle surface electromyography (sEMG) when comparing a 
combined hip activation and core stabilization training HEP to a hip activation 
training HEP.  
Specific Aim 4: To determine whether a dose-response relationship exists between 
HEP compliance and change on the FSDT, peak external knee abduction moment, 
and sEMG.  
1.2 Specific Aim 1:   
H0: There will be no between and/or within-group differences on the FSDT between 
the hip-activation group and the hip-activation-plus-core-stabilization group.  
H1: There will be between and/or within-group differences on the FSDT between the 
hip-activation group and the hip-activation-plus-core-stabilization group.  
Specific Aim 2:   
H0: There will be no between and/or within-group differences on the peak external 
knee abduction moment during a drop landing task between the hip-activation group 
and the hip-activation-plus-core-stabilization group.  
H1: There will be between and/or within-group differences on the peak external knee 
abduction moment during a drop landing task between the hip-activation group and 
the hip-activation-plus-core-stabilization group.  
Specific Aim 3:   
H0: There will be no between and/or within-group difference on the sEMG data 
between the hip-activation group and the hip-activation-plus-core-stabilization 
group.  
H1: There will be between and/or within-group differences on the sEMG between the 
hip-activation group and the hip-activation-plus-core-stabilization group.  
Specific Aim 4:   
H0: There will be no dose-response relationship between HEP compliance and change 
on the FSDT.  

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H1: There will be a dose-response relationship between HEP compliance and change 
on the FSDT.  
H0: There will be no dose-response relationship between HEP compliance and change 
on the peak external knee abduction moment during a drop landing task.  
H1: There will be a dose-response relationship between HEP compliance and change 
on the peak external knee abduction moment during a drop landing task.  
H0: There will be no dose-response relationship between HEP compliance and change 
on the sEMG.  
H1: There will be a dose-response relationship between e HEP compliance and 
change on the sEMG.  
2.0 
Background* 
2.1 Knee injuries accounted for an estimated six and a half million visits to the emergency 
room between 1999 and 2008, and prevalence of knee pain has increased substantially over 
the last several decades with notably high incidence of patellofemoral pain.1,2 A recent shift 
in the literature occurred regarding the treatment of persons with knee pain, particularly 
those diagnosed with patellofemoral pain syndrome (PFPS), with focus being more on hip 
activation programs for treatment.3 Individuals with PFPS are known to exhibit hip and 
knee musculature weakness that most likely evolved from inactivity due to pain.3 
Treatment for PFPS previously involved targeting patella tracking abnormalities through 
the quadricep muscles.4 While this may be the case during non-weight bearing activities in 
which the tibia is moving on a fixed femur, recent investigations have found proximal 
musculature plays a major role in distal LE mechanics in closed chain activities.5,6 This 
data is enhancing the importance of clinicians to include assessments on the joints proximal 
and distal to the sites where injuries occur due to the closed chain nature of injury-prone 
activities and utilizing proximal musculature as an intervention for distal pathologies.6   
Since it is known that proximal stability elicits distal mobility, having a core that can 
sustain high load in all three planes of motion is valuable for lower limb training.6,7 Core 
stabilization is an important component of most gross motor activities, for compromised 
core stability creates an unstable proximal base.8 This causes limitations in control and 
positioning of the LE for functional movements and increases injury risk.7 Previous 
research suggests that core stabilization etiologies when left untreated can lead to injuries 
in the lumbar spine, hip and pelvis, shoulder, knee, and ankle.8 Core stabilization programs 
have been shown to effectively improve physical function, and exercises utilizing isometric 
holds have been shown to improve recruitment of the hip muscles during weight bearing 
activities.9   
Despite the considerable evidence that core musculature impacts LE function, there is a gap 
in research regarding the effects of core stabilization training versus core stabilization plus 
hip activation training to improve LE function.7 Our aim is to determine whether 
differences exist between a combined core stabilization and hip activation HEP as 
compared to a hip activation HEP when trying to improve LE function.   
2.2 Our participants will perform either a hip activation HEP or a hip activation and core 
stabilization HEP for eight weeks. This is the first investigation on this topic by three of the 
authors; however, two authors (DF and EM) have previously published articles utilizing the 
FSDT as a primary outcome measure, using the same methodology for assessment in this 

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study.10 This study also builds on an unpublished clinical trial from the institution. Previous 
HEP protocols will be used for both groups to maintain interrater reliability.4,11,12 The 
effects of a hip activation plus core stability HEP will be compared to the previously 
studied hip activation HEP utilizing the FSDT, the drop-landing task to observe peak knee 
abduction, sEMG data, and compliance of the HEP to determine a dose-response predictive 
correlation. 
2.3 The FSDT is a functional outcome measure used to assess quality and control of frontal 
plane LE movement.14 The FSDT can be used to determine how well an individual can 
ascend and descend stairs by observing eccentric quadricep action and overall balance and 
proprioception.14,15 The FSDT has an established intrarater reliability for a visual 
movement assessment and provides a more accurate evaluation of function than bilateral 
tests while being simple and inexpensive to administer.14,15  
The drop-landing task is an outcome measure that is utilized to evaluate neuromuscular 
control of the peak knee abduction moment in frontal plane landing mechanics.16 It can be 
an efficient way of determining how the impact of the landing force can alter the knee 
biomechanics and put an individual at a greater risk of knee injuries.16 The main 
component of the task is analyzing the rapid change in the knee abduction moment during 
initial contact via force plates.16 Landing after jumping off a platform creates a ground 
reaction force (GRF) that is equal to bodyweight times velocity, a force that is greater than 
is sustainable for the knee.17 On average, performing a drop landing task from a 0.3-meter 
box produces a peak vertical GRF of 4.5 times the individual's body weight.17 This 
increased demand of force causes structures up the biomechanical chain to compensate in 
order to protect the knee joint.  
Home-based programming is valuable for use with patients with barriers to attending in-
clinic treatment and for maintenance plans for discharged patients. There is limited 
research involving home-based treatment as the primary intervention, perhaps because 
compliance with home programs can be affected by lack of accountability, psychological 
and environmental factors, and difficulty with verifying compliance.18  
Compliance of the intervention protocol and the amount of change in the dependent 
variable pre- and post- intervention has been established as a reliable way to determine a 
dose-response relationship.12 In this investigation, the authors aim to analyze the dose-
response predictive relationship between compliance of the intervention sessions and 
altered FSDT scores, as well as changes in transversus abdominus (TA), gluteus maximus 
(GMax), and gluteus medius (GMed) activation via sEMG evaluation.  
Our aim is it determine if an eight-week hip musculature activation and core stabilization 
HEP influences FSDT scores, the knee abduction moment via the drop-landing task, and 
sEMG of the TA, GMax, and GMed, and to assess whether a dose-response relationship 
exists between HEP compliance and changes in these measures over time.  
As a result of the limited research, clinicians are continually challenged with best practices 
for assessing and training core stability and LE injuries.7 This study will help build on the 
limited evidence to see if a core stabilization program plus hip activation will lead to 
optimal outcomes when designing a treatment plan for LE impairments.   
3.0 
Inclusion and Exclusion Criteria* 

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3.1 Screening will be performed synchronously with the written informed consent process 
through a self-reported assessment.  
3.2 Inclusion: Participants will be current first- or second-year Doctor of Physical Therapy 
(DPT) students in the School of Allied Health Professions (SAHP) at LSU Health 
Shreveport over the age of 21.  
Exclusion: Current pain or pathology in either LE which currently limits their ability to 
perform the FSDT or drop landing task, a history of low back pain in the last three months, 
known pregnancy, as pregnancy is a risk factor for diastasis rectus abdominis (DRA)19 
which may be exacerbated by participation in the intervention and could be a confounding 
variable, and current participation in other clinical trials.   
3.3 Regarding the inclusion of persons at increased risk:  
• Adults unable to consent: excluded due to not meeting inclusion criteria.  
• Individuals who are not yet adults (infants, children, teenagers): excluded because 
this is not the target population.  
• Pregnant women: excluded due to the risk of developing DRA19 that may be 
exacerbated by the intervention, creating greater than minimal risk to this 
population.  
• Prisoners: excluded due to not meeting inclusion criteria.  
4.0 
Study-Wide Number of Subjects* 
4.1 N/A, not muti-institutional 
4.2 
N/A 
5.0 
Study-Wide Recruitment Methods* 
5.1 N/A, not multi-institutional. 
5.2 N/A, not multi-institutional. 
5.3 N/A, not multi-institutional. 
6.0 
Multi-Site Research* 
6.1 N/A, not multi-institutional. 
6.2 N/A, not multi-institutional. 
6.3 N/A, not multi-institutional. 
7.0 
Study Timelines* 
7.1 The duration of an individual subject’s participation in the study is ten weeks, consisting of 
one week of data collection to measure and record anthropometrics, sEMG, FSDT, Drop 
Landing Task, and teach the HEP, an eight-week intervention program, and one week of 
data collection to measure the FSDT, Drop Landing Task, and sEMG measurements after 
the intervention program. The estimated completion date for this study is August 2024.  
8.0 
Study Endpoints* 

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8.1 The primary study endpoint is the completion of data collection and intervention for all 
participants, which will be completed by May 2024. The secondary study endpoint is the 
completion of handling PHI, which will be completed August 2024.  
8.2 Refer to 8.1. 
9.0 
Procedures Involved* 
9.1 The study will be a single-blind randomized controlled trial utilizing a repeated-measures 
design, where all participants will perform the FSDT and Drop Landing Task for 
assessment pre- and post- HEP intervention. Concurrent to the functional movement 
assessment, sEMG data will be collected from the GMed, GMax, and TA, and 
kinetic/kinematic data will be collected via motion analysis. The investigator conducting 
the statistical analysis (DF) will not be involved in the randomization procedure and will be 
blinded to participant grouping. The participant key, which will denote group assignment 
will not be available to the PI, and group assignments will be provided to him to each 
participant number only for data analysis. Participants will be randomized into groups with 
opaque envelopes for allocation concealment as described by Clark et al.20 The envelope 
will be sealed and have an additional security method of the person who created the 
envelope signing the back so it is obvious if it has been tampered with.20 The person who 
creates the envelopes does not recruit any participants to prevent the ordering of 
participants into one treatment arm or another.20 The hip activation HEP group will receive 
a combination of hip musculature activation exercises used by previous researchers that 
show an increase in hip muscle recruitment.5,21 The hip activation plus core stabilization 
HEP group will receive the same hip exercises, plus core stabilization exercises used by 
previous researchers that showed a reduction in the external knee adduction moment.10 In 
this design, the dependent variables are the scores on the FSDT, the peak external knee 
abduction moment as assessed during the Drop Landing Task, and sEMG (GMax, GMed, 
and TA), all on the dominant LE, and compliance with the HEP. The independent variable 
is the performance of the eight-week HEP. Three physical therapy students will perform 
the FSDT assessments and sEMG data collection (CB, TM, RS). Two faculty members will 
also assist with data collection (DF and EM). Prior to data collection and assessments, the 
three students (CB, TM, RS) will be educated by the primary investigator (DF), who is a 
board-certified orthopaedic clinical specialist and licensed physical therapist with eleven 
years of experience, on the FSDT protocol and on the Drop Landing Task protocol. The 
scoring guidelines of the FSDT will be reviewed and practiced prior to data collection.15 
The same methodology will be used from McCallister and Flowers11 for scoring and 
reporting of the FSDT scores. The sEMG electrode placement will come from The ABC of 
EMG.22 The procedure for collection of the maximum volitional isometric contraction 
(MVIC) of the GMed will follow the protocol used in a study by Harput et al.23 The MVIC 
position of the GMax will follow the protocol used in a study by Selkowitz et al, with the 
knee flexed to 90o in prone.24,25 The MVIC position of the TA will follow the protocol used 
in a study by Okubo et al, at the elbow-toe with contralateral arm and leg lift in the 
quadruped position.26 Once the participant has completed MVIC, reflected markers will be 
placed and they will perform a static then functional calibration on both LE. For the 
functional calibration, the participant will actively move their hip in space (hip flexion, 45-
degree angle anterolateral, hip abduction, 45-degree angle posterolateral, and hip 
extension), flex and extend the knee, and dorsiflex, plantarflex, and perform ankle circles to 
calibrate appropriately for the dynamic task. 

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9.2 Two investigators (CB, RS) will recruit the DPT class of 2025 in a group setting via word-
of-mouth. During this time, the investigators will obtain informed consent of those students 
wishing to participate and who have self-reported that they meet the inclusion/exclusion 
criteria. If the required number of participants is not met (N = 34), the other investigator 
(TM) will recruit students from the DPT class of 2026 cohort via word-of-mouth about the 
investigation and obtain informed consent until the required number of participants are 
enrolled. After enrollment, each participant will sign up for a time to attend an initial data 
collection session in the Rehabilitation Faculty Clinic and the Motion Analysis Laboratory 
(Rm 2-217), both located in the SAHP at LSUHS. A randomization sequence will be 
created using Microsoft Excel by inputting 17 entries for each group and using the 
functions to sort by random array. The sequence will be printed on paper inserts. The 
inserts will be placed in sequentially numbered opaque envelopes and sealed by TM, who 
will then sign on the back of the envelope over the seam. Participants will meet in the 
Rehabilitation Faculty Clinic and age, sex, height, weight, BMI, and dominant LE will be 
recorded by DF or EM. The dominant LE is defined as the leg that they usually use to kick 
a soccer ball.11 Participants will take the elevator to the second floor and report to 2-217 for 
sEMG, FSDT, and Drop Landing Task force plate data collection. Additional 
anthropometrics consisting of leg length, knee width, and ankle width will be obtained for 
accurate motion capture. Then, sEMG electrodes (“Self-adhesive Ag/AgCl Dual 
Electrodes” by Noraxon) will be applied to the GMax, GMed, and TA of the side of the 
dominant leg, following the placement criteria from The ABC of EMG by EM (for female 
participants) or DF (for male participants) and an MVIC for each muscle will be performed 
and recorded, with resistance by RS.22,24,25 Motion capture markers will be placed on 
participants by a single student investigator at the following locations bilaterally: ASIS, 
PSIS, lateral epicondyle at the knee, lateral thigh, lateral shank, lateral malleolus, 
calcaneus, and head of the second metatarsal. Plug-in-Gait (PiG) static calibration and 
functional calibration for the knee joint will be performed before performing outcome 
measures. Participants will be instructed on the procedure for the FSDT by RS prior to 
completing the test. The FSDT consists of five consecutive repetitions of a forward step 
down from a 20 cm step, with one score given for the whole set of five repetitions.15 Two 
student investigators (TM, RS) will score via a score sheet and average the number 
between the scores.15 The Drop Landing Task will be instructed by TM and consist of three 
trials of dropping from a 30 cm box to land on the force plate for the average knee 
abduction moment across the trials.27 sEMG data, FSDT scores and motion, and Drop 
Landing Task force plate and motion capture data will be collected before and after the 8-
week HEP. After the initial FSDT and Drop Landing Task are completed, CB will draw the 
next sequentially numbered envelope and escort the participant to another room to open the 
opaque envelope, educate the participant on the HEP, and explain the compliance chart to 
the participant. Each participant will demonstrate the exercises of the HEP to ensure proper 
form and will be informed on the proper progression of the exercises. A compliance chart 
will be given to the participants to track every time they perform the HEP. Previous authors 
have used compliance charts to measure this variable in preparation for a dose-response 
analysis for activation programs.10 The participants will take home their HEP, a compliance 
chart, and resistance bands. The participants will complete either the hip activation and 

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core stabilization HEP two days a week for eight weeks described by Flowers et al.12 or the 
hip activation HEP alone described by Cannon et al.13 for two days a week for eight weeks, 
with at least two rest days between sessions, and document the completion of the session 
on the compliance chart. At the end of the 8-week period, each participant will be 
scheduled to return for post-completion anthropometics data collection and to room 2-217 
to turn in their compliance sheet and perform a follow-up sEMG, FSDT, and Drop Landing 
Task using the same procedures as before.  
9.3 Table of events that lists each procedure or test and how often the procedure or test will 
occur.   
Written Informed Consent  
1  
Eligibility Screening  
1  
Anthropometric Assessment (height, sex, weight, BMI)  
2  
FSDT  
2  
sEMG  
2  
Drop Landing Task  
2  
HEP education  
1  
Compliance chart education  
1  
HEP  
16 
Compliance chart documentation  
16 
9.4 To reduce the risk of muscle soreness, participants will be educated on proper performance 
of the exercises, to space sessions at least two days apart, and to progress to a resistance 
band once they can perform all exercises for one consecutive minute on the dominant LE. 
An informed consent document with participant identification numbers will be used to 
obtain consent from the participants. A participant identification number key will be made 
to match the participant's name to their assigned number to maintain confidentiality. A sign 
up for the anthropometric data collection and pre- and post-HEP sEMG and FSDT data 
collection will be created, allowing the participants to sign up with their identification 
number. A Microsoft Excel sheet (shared among the investigators on SharePoint and 
password protected) to collect data will be used by the investigators. A compliance chart 
for the participants to track their exercise sessions will be created. A paper copy of the HEP 
will be given to the participants. All hardcopy informed consents and grading sheets will be 
maintained in the PI’s office (SAHP Rm 2-234) in a locked cabinet.  
 
9.5 Data collected will consist of participant age, sex, height, weight, BMI, and MVIC (GMax, 
GMed, and TA), in addition to the following pre- and post- intervention: FSDT, peak 
external knee abduction moment, sEMG from GMax, GMed, and TA, recorded FSDT 
video, and recorded drop landing task video. The data from the compliance chart will only 
be collected post-intervention.  
9.6 N/A 
9.7 N/A 
10.0 Data and Specimen Banking* 

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10.1 N/A 
10.2 N/A 
10.3 N/A 
11.0 Data Management and Confidentiality* 
11.1 Descriptive statistics will be provided for the demographic data to compare age, sex, 
height, weight, BMI, dominant LE, and MVIC of the TA, GMax, and GMed.  
FSDT   
The FSDT data will be analyzed using a 2 x 2 mixed ANOVA to evaluate for between- 
and within-group differences.  
sEMG   
Data processing: Raw sEMG signals will be bandpass filtered between 10-500 Hz. The 
signal will be rectified, then smoothed using the Root Mean Square method with a 50ms 
window. The signal will be normalized to the MVIC obtained during the MVIC testing.   
Data analysis: Following MVIC normalization, the mean EMG activation and peak EMG 
activation for each trial will be recorded. Each step-down repetition will be analyzed as a 
separate trial, and an average taken of all 5 trials to provide the data for each muscle pre- 
and post-test. The same procedure will take place for all three Drop Landing Task trials. 
The mean data for each sEMG data point will be analyzed via a 2 x 2 mixed ANOVA for 
each outcome variable.  
Drop Landing Task force plate: Data processing: Motion capture data will be processed in 
Vicon’s Nexus2 software using the PiG model. Gaps will be filled using the appropriate 
gap fill strategy. External knee abduction moment will be extracted from the kinetic data.  
Data analysis: A 2 x 2 mixed ANOVA will be used to evaluate for between- and within-
group differences on the peak knee abduction moment during the Drop Landing Task.    
Regression analysis: Regression analyses will be performed to determine whether a dose-
response analysis exists between the HEP compliance and the dependent variables.  
11.2 G*power (Heinrich-Heine-University Düsseldorf, Düsseldorf, Germany) software was used 
to perform an a priori power analysis to determine the required N for this investigation. 
Data was obtained from McCallister and Flowers (2020),11 which showed a significant 
within-groups difference pre-exertion and five minutes post-exertion change on the FSDT 
(r = .27). Pearson’s coefficient was converted to Cohen's d (d = .56). An N of 28 was 
calculated to achieve significant results, with beta = .80 and alpha = .05 for a two-tailed 
hypothesis from a 2 x 2 mixed ANOVA analysis. We assumed an attrition rate of 20% 
given the repeated-measures design of the investigation. Therefore, a final N of 34 will be 
recruited for the successful completion of this study.  
11.3 See 9.4. 
11.4 The student investigators (TM, RS, and CB) will be educated on the proper procedures of 
the FSDT, Drop Landing Task, sEMG data collection, force plate data collection, and the 
HEP by the primary investigator (DF) and co-investigator (EM). The FSDT will be 
analyzed and scored by two student investigators (TM and RS). TM and RS will record and 
average their scores following the completion of five repetitions to improve the quality of 

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the data.11 The sEMG electrodes will be placed on the female participants by EM and on 
the male participants by DF. RS will provide the pressure for the MVIC and explain the 
FSDT procedure to every participant. TM will explain the drop landing task procedure to 
every participant. CB will draw the next sequentially numbered envelope and escort the 
participant to another room to open the envelope, explain the HEP, and explain the 
compliance chart to the participant. The primary investigator (DF) is a board-certified 
orthopedic physical therapist with 11 years of experience, who has published research on 
this test.11 The co-investigator (EM) is also a board-certified orthopedic physical therapist 
with 6 years of experience, who also published research on this test with the primary 
investigator.11  
11.5 The data that will be collected during the entire study includes: participant number, age, 
height, weight, BMI, sex, MVIC of GMax, GMed, and TA, leg dominance, FSDT pre and 
post HEP, recorded FSDT video, sEMG from GMed, GMax, and TA on the side of the 
dominant leg during FSDT pre and post HEP, peak external knee abduction moment during 
the Drop Landing Task pre and post HEP, recorded Drop Landing Task video, and 
compliance. Data storage will follow the guidelines in section 9.4. The data will be stored 
for the duration of the study and throughout the following semester while analyzing and 
finalizing data for presentation. The data will be kept up to one year after the completion of 
the data analysis in the event that the research wants to be continued. The only people to 
have access to this information will be the primary investigator, the co-investigator, and 
student investigators (DF, EM, CB, TM, RS). All investigators are responsible for the 
receipt and transmission of the data. Data will be manually transported to DF office room 
2-234 in the SAHP at LSUHS. Electronic data will remain on SharePoint.  
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* 
12.1 N/A 
13.0 Withdrawal of Subjects* 
13.1 Non-study related injury that alters participant ability to complete HEP or FSDT post 
intervention.  
13.2 If the participant notifies any investigator that they do not wish to participate any longer or 
if they no longer meet the inclusion/exclusion criteria, the investigators will notify the 
participant that they have been withdrawn from the study and document the reason for the 
withdrawal and date. The participant will provide the returned compliance sheet to the 
investigators.  
13.3 N/A 
14.0 Risks to Subjects* 
14.1 Risks associated with this study include:  
• Physical risks: muscle soreness is a potential side effect that may occur with exercise. 
This will be minimized via the progression principles previously outlined in section 
9.4. This is likely to happen but will be minimized via progression principles that will be 
taught to you at the first study visit. The magnitude of this risk is minor. Another risk is 
skin irritation and/or a rash from wearing or removing the electrode patches that stick to the 
skin for sEMG and for 3D Motion Capture markers. If participants become pregnant during 
the study, they should tell the study investigators. They may be removed from the study 

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due to risk of developing separation of the abdominal muscles called diastasis recti. It is not 
expected that the baby’s health or mother’s health will need to be followed. 
• Privacy/confidentiality risks: participants’ personal information could be lost or exposed. 
This is very unlikely to happen, and all hardcopy data will be locked in the PI’s office. 
Digital data is password protected. Given the nature of the personal information collected, 
the magnitude of this risk is minor. 
• Modesty: participants’ buttocks will be exposed for the placement of the electrode 
stickers. An investigator of each participants’ same sex will drape them to minimize 
exposure and will place the electrode stickers on their buttocks. 
14.2 N/A 
14.3 N/A 
14.4 N/A 
15.0 Potential Benefits to Subjects* 
15.1 The potential benefits that an individual may experience from taking part in this 
investigation are improved frontal plane trunk and LE mechanics, improved GMed, GMax, 
and TA activation. 
15.2 N/A 
16.0 Vulnerable Populations* 
16.1 N/A  
17.0 Community-Based Participatory Research* 
17.1 N/A 
18.0 Sharing of Results with Subjects* 
18.1 Participants will not receive their individual results.   
19.0 Setting 
19.1 This study will recruit potential subjects from the LSUHS DPT cohorts of 2025 and 2026 
in Shreveport, LA. Recruitment will take place via the procedures outlined in section 9.2. 
Procedures for research will be performed in the SAHP at LSUHS. Anthropometric data 
will be collected in the Rehabilitation Faculty Clinic. The motion analysis lab, room 2-217, 
will be used for the sEMG data collection, FSDT, and education of the HEP. There is no 
composition or involvement of any community advisory board. The research will not be 
conducted outside of the organization or its affiliates. 
20.0 Resources Available 
20.1 The three student investigators (TM, RS, CB) are DPT students in the 2025 cohort at 
LSUHS. They will be educated on the procedures of the FSDT, described in Park et al,15 
procedures of the Drop Landing Task, described in Fan et al,27 sEMG electrode 
placement,21,22,24,25 and data collection and interpretation21 by the primary investigator 
(DF), who is a board-certified orthopedic physical therapist with 11 years of experience 
and the co-investigator (EM), who is a board-certified orthopedic physical therapist with 6 
years of experience. The primary (DF) and co-investigator (EM) will assist the student 

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investigators as needed throughout the study, including assisting with data collection and 
analysis. 
20.2 The total number of first- and second-year DPT students enrolled in the SAHP at LSUHS is 
71. Given the required N = 34, there are enough potential participants to successfully 
complete this investigation. The student investigators (CB, TM, RS) are enrolled in an 
independent study for the Fall 2023 semester to receive IRB approval. In the spring of 
2024, the data collection portion of the study will begin and be concluded by May 2024. 
The investigators will be enrolled in Research IV during this semester to allow time to 
begin working on the poster presentation. Drs. Flowers and McCallister will each provide 
5% FTE for their involvement in the study. During the summer semester of 2024, the 
student investigators will begin analyzing the data and disseminating the findings. All data 
analysis will be concluded by August 2024. The motion analysis lab, room 2-217 in SAHP 
at LSUHS has a treatment mat, sEMG materials and technology, in addition a large open 
space used for motion analysis. The Rehabilitation Faculty Clinic is located on the ground 
floor of the SAHP at LSUHS and is where the anthropometric data will be collected. Our 
study has less than minimal risk. The PI will complete the DOA, including the assigning of 
roles and responsibilities, and educate each investigator at the time of signing. 
21.0 Prior Approvals 
21.1 Dr. Edward Mahoney will need to provide approval for the study to commence since he 
serves as Chair of the Physical Therapy Department. 
22.0 Recruitment Methods (Local) 
22.1 Two investigators (CB, RS) will inform the 2025 DPT cohort in a classroom at LSUHS via 
word of mouth. During this time, the investigators will obtain informed consent. If the 
required number of participants is not met (N = 34), the other investigator (TM) will recruit 
students from the 2026 DPT cohort via word-of-mouth about the investigation and obtain 
informed consent until the required number of participants are enrolled. 
22.2 The subjects will be either 1st or 2nd year DPT students in the SAHP at LSUHS. 
22.3 Potential subjects will first be identified from DPT class of 2025 by entering a classroom at 
the SAHP at LSUHS. If more participants are needed, the remainder will be recruited via 
word of mouth from the DPT class of 2026 cohort. 
22.4 N/A 
22.5 N/A 
23.0 Local Number of Subjects 
23.1 At least 34 participants will be recruited locally. 
23.2 N/A 
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 Individuals participating in the study will be given an identification number to protect their 
personal identity. Participants will only be expected to interact and provide personal 
information to the investigators on the study. 
24.2 There will only be the investigators in the room during data collection, and any questions 
will be asked individually with the investigators. If another participant is to be in the room 

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learning the HEP, the view will be obstructed with a divider to ensure confidentiality. Any 
written data will refer to the participants with numbers, not actual names. No previous 
medical history will be entered into the data collection. 
24.3 Any information about the subjects will be verbally reported to investigators.  
25.0 Compensation for Research-Related Injury 
25.1 It does not involve greater than minimal risk. 
25.2 N/A 
26.0 Economic Burden to Subjects 
26.1 There will be no economic burden to the participants. Any required materials will be 
provided. The only thing the participants will be responsible for is transportation to the 
facility where study is conducted. 
27.0 Consent Process 
27.1 The consent process will take place in classrooms at the SAHP at LSUHS. There is no 
waiting period between informing the prospective subject and obtaining the consent. 
Continued verbal consent will be given during the FSDT/sEMG/Drop Landing Task 
process both before and after HEP. We will be using “SOP: Informed Consent Process for 
Research (HRP-090).”  
Non-English-Speaking Subjects 
• N/A 
Waiver or Alteration of Consent Process (consent will not be obtained, required 
information will not be disclosed, or the research involves deception) 
• N/A 
Subjects who are not yet adults (infants, children, teenagers) 
• N/A 
Cognitively Impaired Adults 
• N/A 
Adults Unable to Consent 
• N/A 
Adults Unable to Consent 
• N/A 
28.0 Process to Document Consent in Writing 

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28.1 We will be using “SOP: Written Documentation of Consent (HRP-091).”  
28.2 Our research does not involve more than minimal risk.  
28.3 See attached completed informed consent form submitted with this protocol. *  
29.0 Drugs or Devices 
• 
N/A 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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24. Selkowitz DM, Beneck GJ, Powers CM. Which exercises target the gluteal muscles while 
minimizing activation of the tensor fascia lata? Electromyographic assessment using fine-wire 
electrodes. J Orthop Sports Phys Ther. 2013;43(2):54- 64. doi:10.2519/jospt.2013.4116  
25. Selkowitz DM, Beneck GJ, Powers CM. Comparison of electromyographic activity of the 
superior and inferior portions of the gluteus maximus muscle during common therapeutic 
exercises. J Orthop Sports Phys Ther. 2016;46(9):794-799. doi:10.2519/jospt.2016.6493  
26. Okubo Y, Kaneoka K, Imai A, et al. Electromyographic analysis of transversus abdominis and 
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Phys Ther. 2010;40(11):743-750. doi:10.2519/jospt.2010.3192  
27. Fan B, Xia H, Xu J, Li Q, Shull PB. IMU-based knee flexion, abduction and internal rotation 
estimation during drop landing and cutting tasks. Journal of Biomechanics. 2021;124:110549. 
doi:https://doi.org/10.1016/j.jbiomech.2021.110549