Effects of Isometric Gluteal Activation Plus Movement Retraining vs. Gluteal Activation Alone on the Forward Step-Down Test
Phase: NA
Conditions: Movement, Abnormal, Lower Extremity Problem
Sponsor: Louisiana State University Health Sciences Center Shreveport

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PROTOCOL TITLE: 
 
Effects of Isometric Gluteal Activation Plus Movement Retraining vs. Gluteal 
Activation Alone on the Forward Step-Down Test  
 
PRINCIPAL INVESTIGATOR:  
Name: Erin McCallister, PT, DPT 
Department: Physical Therapy 
Telephone Number: 318-813-3502 
Email Address: erin.mccallister@lsuhs.edu 
VERSION NUMBER: 
1 
DATE: 
November 13, 2025 
 

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Table of Contents 
1.0 
Objectives* ...........................................................................................................................3 
2.0 
Background* .........................................................................................................................4 
3.0 
Inclusion and Exclusion Criteria* .........................................................................................7 
4.0 
Study-Wide Number of Subjects* ........................................................................................8 
5.0 
Study-Wide Recruitment Methods* .....................................................................................8 
6.0 
Multi-Site Research* ............................................................................................................8 
7.0 
Study Timelines* ..................................................................................................................8 
8.0 
Study Endpoints* ..................................................................................................................9 
9.0 
Procedures Involved*............................................................................................................9 
10.0 Data and Specimen Banking* .............................................................................................13 
11.0 Data Management and Confidentiality* .............................................................................14 
12.0 Provisions to Monitor the Data to Ensure the Safety of Subjects* .....................................16 
13.0 Withdrawal of Subjects* .....................................................................................................16 
14.0 Risks to Subjects* ...............................................................................................................16 
15.0 Potential Benefits to Subjects* ...........................................................................................16 
16.0 Vulnerable Populations* .....................................................................................................17 
17.0 Community-Based Participatory Research* .......................................................................17 
18.0 Sharing of Results with Subjects* ......................................................................................17 
19.0 Setting .................................................................................................................................17 
20.0 Resources Available............................................................................................................17 
21.0 Prior Approvals ...................................................................................................................18 
22.0 Recruitment Methods ..........................................................................................................18 
23.0 Local Number of Subjects ..................................................................................................19 
24.0 Provisions to Protect the Privacy Interests of Subjects .......................................................19 
25.0 Compensation for Research-Related Injury ........................................................................19 
26.0 Economic Burden to Subjects .............................................................................................19 
27.0 Consent Process ..................................................................................................................19 
28.0 Process to Document Consent in Writing ...........................................................................20 
29.0 Drugs or Devices.................................................................................................................20 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1.0 
Objectives* 
1.1 The purpose of this study is to determine if an isometric glutealactivation 
home exercise program (HEP) combined with a movement retraining 
program utilizing feedback cues produces significant changes in scores on 
the Forward Step-Down Test (FSDT) in healthy young adults with 
movement coordination impairments. 
• SA1: To determine if an isometric gluteal activation HEP with a 
movement retraining program with feedback cues produces 
significant changes on scores FSDT compared to the gluteal 
activation HEP alone.   
• SA2: To determine if an isometric gluteal activation HEP followed 
with a movement retraining program with feedback cues produces 
significant changes on category FSDT compared to gluteal activation 
HEP alone. 
• SA3: To determine if an isometric gluteal activation HEP with a 
movement retraining program with feedback cues produces 
changes in the peak activation of the gluteus medius and gluteus max 
during the FSDT compared to the gluteal activation HEP alone. 
• SA4: To determine if an isometric gluteal activation HEP with a 
movement retraining program with feedback cues produces changes 
in the mean activation of the glute med and glute max during the 
FSDT compared to the gluteal activation HEP alone. 
• SA5: To determine if HEP dose has an effect on the FSDT response, 
as measured by change in score on the FSDT.  
1.2  
• SA1: FSDT  
o Ho: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will have 
no change on FSDT score. 
o H1: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will 
change FSDT scores more than a gluteal activation program 
alone. 
• SA2: FSDT  
o Ho: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will have 
no change on movement quality categorization. 
o H1: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will have 
a greater change on movement quality category than the 
gluteal activation program alone. 

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• SA3: Peak Activation, FSDT 
o Ho: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will not 
produce a significant change MVIC of the glute med and glute 
max.   
o H1: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will 
significantly change the peak MVIC of the glute med and glute 
max compared to the gluteal activation program alone. 
• SA4: Mean Activation, FSDT 
o Ho: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will not 
produce a significant change the mean MVIC of the glute med 
and glute max.   
o H1: An HEP focusing on isometric gluteal activation with a 
movement retraining program with feedback cues will 
significantly change the mean MVIC of the glute med and 
glute max compared to the gluteal activation program alone. 
• SA5: Dose Response, FSDT 
o Ho: Increased adherence to a HEP will not change scores on 
the FSDT or MVIC of glute max or glute med. 
o H1: Increased adherence to a HEP will significantly change 
scores on the FSDT and/or MVIC of glute max or glute med. 
2.0 
Background* 
2.1 Poor biomechanics due to a deficiency of neuromuscular control at the hip 
contribute to knee joint injuries. Neuromuscular control of the proximal 
femur plays a key role in tibiofemoral joint positioning.1 When lacking 
strength and neuromuscular control of the gluteus maximus (Gmax) and 
gluteus medius (Gmed), the femur internally rotates and adducts during 
single-limb movements such as in the Forward Step Down Test (FSDT).2 
Such movements put the knee into a position of excessive valgus which is a 
combination of movements: adduction and internal rotation of the femur, 
abduction of the knee, anterior tibial translation, external tibial rotation, and 
ankle eversion.3 The combination of these movements increases injury risk 
at the knee.4 The FSTD aims to evaluate several of these movements 
isolated to the frontal plane which is controlled in majority by the Gmed.  
Previous studies have been conducted to explore if different combinations of 
exercises in a home exercise program (HEP) can help to improve scores on 
the FDST. These HEPs from past studies included a hip activation program, 
a combined hip activation and single-leg balance program, and a combined 
hip activation and core activation program.  However, despite increases in 
activation of the Gmed as seen by surface electromyography (sEMG) data, 

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there was minimal indication that these programs caused a significant 
improvement in mean score on the FSDT itself. 5,6 The hip activation 
program alone did not cause functional change in the participant’s frontal 
plane movement quality by decreasing their FSDT score a clinically 
significant amount. It did improve the participants' strength with statistical 
significance. Training functional movements to improve movement patterns 
using motor learning while incorporating dynamic hip activation exercises 
and its effect on the FDST have yet to be investigated. This study aims to 
explore the relationship between adding visual and auditory feedback to 
functional dynamic exercises that activate the gluteal muscles in an HEP and 
hip activation exercises with scores on the FDST. Despite the frequent use 
of the FSDT to look at functional movement patterns in patients, there is 
still a need for evidence-based interventions that can consistently improve 
performance on this test which will translate functionally to increased 
dynamic knee stability. 
 
2.2 Our participants will undergo a prescreening utilizing the FSDT. 
Preliminary data will be used for exclusion, stratification, and randomization 
of participants. The FSDT is scored on a 0–6-point scale with 0-1 
categorically defined as good, 2-3 as moderate, and 4+ as poor movement 
quality. A participant will be excluded from the study if their score is 
defined as “good”. Then, stratification will be based upon the participant’s 
categorical FSDT score of either moderate or poor to ensure equal 
representation of the category in each experimental group. Once 
stratification is complete, participants will be randomly assigned into two 
groups. The Control group will receive an HEP focusing on isometric 
gluteal activation while the Experimental group will receive an HEP 
focusing on isometric gluteal activation plus movement retraining program. 
This will be the first study on this topic by the authors. However, two of the 
authors have done prior research using the FSDT as an outcome measure. 5,6 
Similar FSDT and sEMG procedures will be used as in previous studies. In 
this investigation we will compare the effects of an isometric gluteal 
activation HEP vs an isometric gluteal activation plus movement retraining 
HEP. Outcome measures will include FSDT score and movement quality 
category, Gmed and Gmax mean and peak activation via sEMG, and 
compliance measures of both HEP’s to evaluate dose response.  
2.3 The FSDT is a commonly used clinical assessment tool for evaluating lower 
extremity (LE) strength and function.7 It specifically aims to assess postural 
control, neuromuscular control, and strength of the lower extremity.7  
Previous studies have found that healthy individuals may not have proper 
neuromuscular control to manage excessive frontal plane motion during the 
FSDT. 5,6 Research has not been conducted to examine how attempting to 
change or improve individuals' motor programs would affect their 
performance in the FSDT. Movement retraining could be a way to help 
improve frontal plane movement quality in individuals undergoing the 

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FSDT. Movement retraining is defined as a process in which a motor 
program is changed with the goal of reducing pain or injury risk.8  
The essential aspect of a movement retraining program is providing feedback 
during movement execution. The feedback enables individuals to adopt 
correct movement strategies and develop a sense of proper form. Through 
these feedback mechanisms, individuals can assess whether they are 
performing the movement correctly and engaging the appropriate 
musculature.9 This plays a key role in reshaping coordination patterns and 
promoting transferability of motor learning across different tasks, including 
applications in lower extremity rehabilitation.9 Feedback can be delivered in 
several categories, including visual, auditory, or haptic forms.8 Among these 
different types of feedback, visual feedback helps the person to identify and 
correct alignment or movement errors as they execute the movement.10 This 
feedback can be portrayed using videos so that the participant can watch 
someone with proper form to perform the movement. Visual feedback can 
also be portrayed using mirrors to allow the participant to have knowledge 
of their form and execution of the movement. Auditory feedback provides 
external cues describing what the participant should feel or observe while 
performing an exercise. This reinforces the person’s awareness of their 
movement mechanics. Research supports that external feedback and cueing 
strategies, particularly auditory and visual cues, enhance motor learning by 
increasing awareness of body mechanics. It also has the added benefit of 
improving movement retraining outcomes by allowing the person to have 
knowledge of their performance and learning how to improve it.10 
Furthermore, evidence suggests that multimodal feedback, combining 
auditory, visual, or haptic cues, outperforms single-modality feedback by 
offering complementary information that enhances error correction and 
overall motor learning. This augmented feedback should complement, rather 
than replace the body’s intrinsic sensory feedback mechanisms.10  
The goal of the exercises added to the HEP combined with the gluteal activation 
program that has been used previously would be to utilize visual and 
auditory feedback to give immediate cues to enhance postural control during 
dynamic functional exercises. The exercises selected are single leg 
Romanian deadlifts (RDL), split squats, and single leg squats. The selected 
exercises have shown sufficient activation of the gluteus medius and 
maximus muscles.11 Specifically, single-limb squats and single-limb 
deadlifts exercises effectively activated both the Gmed and Gmax.12,13 In 
doing these exercises with feedback, the desired effect would be to increase 
motor learning in the participants training them how to use the muscles 
during dynamic exercises that mimic functional movements by doing 
exercises that increase the activation of the gluteal muscles. By adding the 
dynamic postural control gained from motor learning and combining these 
exercises with gluteal activation exercises that have previously shown 
success in significantly increasing activation could then transfer to 
improvements in FSDT scores and movement quality in the frontal plane.   

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Home Exercise programs (HEPs) provide a means to implement an interventional 
exercise plan to be conducted at the participant’s home. Normally, an HEP 
consists of clear visuals and written instructions that guide the participants 
in completing the exercise effectively. In utilizing videos, as well as visuals 
and written instructions in the HEP for this study, the subjects will benefit 
from both visual and auditory cues given in video form. This combined with 
visual feedback given by the mirror in front of the participant provides 
knowledge of their execution of the movement. The cues combined with the 
knowledge of their performance will help to emphasize correct movement 
patterns.  Research supports the idea that more feedback is not always more 
helpful when engaging in motor learning. Allowing participants to make and 
correct their own errors at home helps to support motor learning retention by 
allowing the participant to self-select the corrections to their movement 
patterns as they engage in the exercise.10 The participant is able to do this by 
attending to and correcting their movement patterns in the mirror as they 
recognize them.  Additionally, the participants will have the ability to 
control the timing of their feedback. By allowing learner to decide the pace 
of feedback, evidence shows that it enhances engagement, confidence, and 
motor learning.14 However, HEP’s rely on patient compliance. Patients are 
expected to adhere to the program and truthfully document a log of 
completion. To check compliance, the log can be monitored throughout the 
process as well as asking the participant to demonstrate the HEP from 
memory.  
Gluteal activation from an isometric activation HEP alone has shown to increase 
performance on the forward step-down test. However, the improvement was 
not found to be clinically significant.7,8 The aim of this study would be to 
build on prior research and create a HEP that could be used to show a 
clinically significant difference in FSDT scores. Over the eight-week 
intervention, this approach will aim to utilize visual and auditory cueing 
used during functional dynamic exercises to improve hip activation by 
increasing postural control which would translate into meaningful 
improvements in FSDT scores and dynamic knee stability. 
 
3.0 
Inclusion and Exclusion Criteria* 
3.1 Individual eligibility will be determined through the Physical Activity 
Readiness Questionnaire Plus (PAR-Q+), which is a self-reported heath 
questionnaire. During a presentation of inclusion/exclusion criteria, 
informed consent will be obtained as well. A preliminary FDST will be 
performed following informed consent to determine if the potential 
participant is eligible to participate in the study and for group stratification 
purposes. 
3.2 Inclusion: Participants must between the ages of 18 and older, if they were 
healthy via the PAR-Q+, and scored a 2 or higher on the FSDT. 

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Exclusion: Participants have any current knee/hip pain, past knee/hip 
pathology in the past 3 months on their dominant leg or that the participant 
believes would impact their ability to participate in the study, or any past LE 
surgery in their dominant leg that the participant believes would impact their 
ability to participate in the study, a concussion in the past 3 months, or if 
they have any vestibular pathology. 
3.3 Inclusion and exclusion of special populations  
• 
Adults unable to consent- Excluded 
• 
Individuals who are not yet adults (infants, children, teenagers)-  
• 
Pregnant women- Excluded 
• 
Prisoners- Excluded 
• 
Non-English-Speaking Subjects- Excluded 
• 
Students/Employees- Included 
4.0 
Study-Wide Number of Subjects*  
4.1 This research study is not a multicenter study. The total number of subjects 
to be accrued from the LSUHS main campus is 38 participants. 
4.2 N/A 
5.0 
Study-Wide Recruitment Methods 
5.1 Potential subjects will be recruited via word of mouth from people who are 
local to Shreveport, LA and local clinical/academic settings during the 
spring of 2026.  
5.2 During a mandatory meeting prior to the start of the study, participants will 
be screened. Participants will fill out a self-reported health questionnaire to 
determine if they have any underlying health conditions that would exclude 
them from participation in the study. Once informed consent has been 
obtained, participants will also be asked to perform a preliminary FSDT to 
determine if they have a score of poor (4+) or moderate (2-3) that would 
include them in the study. 
5.3 N/A 
6.0 
Multi-Site Research 
6.1 N/A 
6.2 N/A 
6.3 N/A  
7.0 
Study Timelines 
7.1 The duration of the individual subject’s participation in this study is 
currently 590 minutes or 9.8 hours during the study which will last for 8 
weeks. Data collection consisting of anthropometrics, sEMG, FSDT, and 
HEP education will require ~45 minutes for measurements and recording of 

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data. Following completion of assigned HEP, FDST and sEMG will be 
measured and the data will be recorded. Both HEPs will take no more than 
25 minutes a session to complete; hence, allocating 50 minutes in total each 
week since two sessions will be completed per week. A mid-participation 
session at 4 weeks is expected to take less than 15 minutes to ensure correct 
exercise completion, and the post-testing is expected to take 20 minutes.  
• 
The duration anticipated to enroll all study subjects is estimated to be 
done over a month during January 2026. 
• 
The estimated completion date of this study, including data analysis, is 
June 2026. 
8.0 
Study Endpoints 
8.1 Both primary and secondary study endpoints will be the completion of data 
collection and intervention for all participants. This will be completed by 
May 2026. Data analysis will be completed by June of 2026.  
8.2 This is a low-risk study. Participants who experience safety concerns during 
the testing process will be stopped. No safety risks from receiving the 
intervention or dropping out of the study are predicted.  
9.0 
Procedures Involved*  
9.1 This study is a randomized control trial with stratification. Preliminary data 
from a preliminary FSDT will be used for exclusion, stratification, and 
randomization so that we can avoid any bias in results. The FSDT is scored 
on a 0–6-point scale with 0-1 categorically defined as good, 2-3 as 
moderate, and 4+ as poor. A participant will be excluded from the study if 
their score is defined as good or a 0-1 score. Then, stratification will be 
based upon the participant’s categorical FSDT score of either moderate or 
poor to ensure equal representation of the category in each group. 
Participants will be randomly assigned to either the control group (hip 
activation HEP) or the experimental group (Hip activation plus movement 
retraining HEP). Individuals will receive their HEP protocol in an opaque 
envelope to ensure allocation concealment. The dependent variables are the 
FSDT score (statistical and clinical significance) and Gmed and Gmax 
sEMG activation (peak and mean). 
9.2 Research procedures being performed and procedures being to monitor 
subjects for safety or minimize risks 
 
Recruitment and Informed Consent Procedures  
• Potential subjects will be recruited via word of mouth from people who are 
local to Shreveport, LA and local clinical/academic settings. Once they are 
recruited, meeting will be held for all potential participants to obtain informed 
consent. Then, the participant will complete a self-reported health 
questionnaire and a preliminary FSDT. If a potential participant cannot be 

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present at this meeting, a meeting will be scheduled with the investigators to 
obtain these measures. 
• To ensure confidentiality, participants will be given a random identification 
number after their informed consent is obtained. Participant scores on the 
initial FSDT screening will be recorded by ID. Randomized stratification will 
take place following enrollment of all participants to ensure an equal 
distribution of FSDT scores between the control and experimental groups.  
• Following enrollment, participants will sign up with their participant number 
for preliminary data collection in the motion analysis lab in room 2-217 in the 
SHPS at LSUHS. The participants will be instructed to wear shorts and 
advised to not wear leggings, tights, or pants or any lotions, both of which 
could impact EMG placement and data collection. 
Anthropometric data collection procedures 
• 
Age, sex, height, weight, BMI, and dominant lower extremity (LE) will be 
recorded in the rehabilitation faculty clinic by GD and DB during the first 
visit. The determinacy of the dominant leg is based on the leg chosen to kick a 
ball at a target.15 
MVIC testing procedure: 
• Participants will then take the elevator to the second floor and report to room 
2-217 for sEMG and FSDT. Electrodes for sEMG will be placed on the 
gluteus maximus and gluteus medius muscles of the dominant leg via Seniam 
guidelines, and skin preparation following recommendations from The ABC’s 
of EMG.16 The electrodes that will be used are self-adhesive Ag/AgCl Dual 
Electrodes by Noraxon. The placement of sEMG electrodes will be completed 
by GD for the female participants and DB for the male participants. Maximum 
Isometric Voluntary Contraction (MVIC) for the GMax and GMed muscle 
will be performed and recorded by GD and DB. SEMG data collection will be 
obtained for MVIC and during performance of the FSDT. 
• 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.17 The participant will lay on their side with their top leg extended at the 
knee and abducted and extended at the hip. The MVIC position of the GMax 
will follow the protocol used in a study by Selkowitz et al, with the knee 
flexed to 90 degrees in prone.18,19 
FSDT procedures 
• Participants will be instructed on the procedure for the FSDT by MM. The 
FSDT consists of five consecutive repetitions of a forward step-down from a 
20cm step, with one score given for the whole set of five repetitions.20,21 The 
participant will be allowed to take two practice repetitions before beginning 
the test. sEMG data and FSDT will be collected before and after the 8 week 
HEP.  

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HEP and Compliance Chart Education Procedures 
• After the initial FSDT and randomization has been completed, the participant 
will be educated on the gluteal muscle activation exercises HEP by (GD or 
DB or MM) (control group) or movement retraining program and gluteal 
muscle activation exercise HEP by (GD or DB or MM) (experimental group). 
Participants will be educated the compliance chart by investigator (GD or DB 
or MM). Compliance chart data will be collected and analyzed during the 
third/final visits.  
• All participants will receive the HEP for hip muscle activation training. The 
HEP for hip musculature activation consists of five isolated hip activation 
exercises including side-lying clams, side-lying clams with trunk activation 
via side-plank, side-lying hip abduction, side-lying hip abduction with trunk 
activation via side-plank, and fire hydrants all of which improve hip gluteal 
recruitment. See HEP for appropriate exercise positioning, dosage, frequency, 
and advised progressions. 
• Only participants in the experimental group will receive the movement 
retraining program HEP. The HEP will be a combination of single leg RDL, 
single leg squat, and standing split squat that have been used in previous 
research and are proved to get significant Gmed activation.11,12,13 They will 
also participate in the gluteal activation HEP program that have been proved 
to increase hip musculature recruitment.  
• A compliance chart will be given to the participants to track each time they 
perform the HEP. The participants in the control group and experimental 
group will take home their HEP, a compliance chart, then a yellow and red 
TheraBand. The participants will complete their HEP two days/week for eight 
weeks, with at least two rest days between sessions for muscle soreness 
prevention and document the completion of the session on the compliance 
chart.  
• After the 4th week, both groups are to return to the clinic and asked to briefly 
perform exercises from their HEP so that their form can be reassessed with 
any modifications if needed along with any questions that they may have. 
Each participant following the 8-week period will be scheduled to return to 
the clinic to turn in their compliance form and perform follow-ups sEMG, 
weight, and FSDT using the same procedures as before.  
Randomization of Group Allocation: Following the baseline EMG and FSDT 
measures, participants will be handed an opaque envelope containing their group 
allocation. Participants in the control group are indicated by a “0”, and 
intervention group by a “1”. A sequence of 1’s and 0’s will be generated by 
random generation in Excel, and the assignment will be made by sequential 
enrollment. To avoid unequal distribution of movement quality between groups, 
initial stratification in to “fair” and “poor” FSDT performance will be established 
after informed consent. Each strata will have an equal distribution of control and 
intervention envelopes.  

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9.3  
Table of Events 
# of times test or procedure 
will be performed 
Written informed consent 
1 
Anthropometric assessment (height, weight, BMI, sex, age, leg 
dominance) 
1 
FSDT 
3 
sEMG 
2 
HEP Education 
1 
Compliance Chart Education 
1 
HEP Midpoint Check in  
1 
HEP 
16 
Compliance chart document 
16 
9.4 To reduce the risk of confidentiality, participants will be assigned 
identification numbers. All hardcopy data including group assignments will 
be stored in the PI’s office in a locked drawer. All electronic data will be 
stored using OneDrive connected to school email addresses with a 
password. The investigator performing the data analysis will be blinded.  
An informed consent document with participant identification numbers will 
be used to obtain consent from the participants. An identification number 
will be assigned to the name of each participant along with their group 
assignment. An identification number key will be used to maintain 
confidentiality when performing data collection and analysis, which will be 
stored on the PI’s password protected computer. Only study members will 
have access to this document. 
A sign-up sheet for the data collection days will be created that will allow 
participants to sign up with their assigned identification number. 
Investigators will use an excel sheet to collect data (see data collection form 
as part of submission). Participants will track their HEP performance on the 
compliance chart that will be provided to each participant. A paper copy of 
the HEP with pictures, written instructions, and a QR code for video 
instructions will be given to the participants. 
To reduce the risk of muscle soreness, participants will be educated on 
appropriate exercise performance and to space the sessions at least two days 
apart. Once all hip activation exercises can be completed for one minute on 
the dominant LE without a break, participants will be educated to add the 
yellow TheraBand. Once the exercises can be completed for one minute 
with the yellow TheraBand on the dominant LE without a break, 
participants will be educated on progressing to the red TheraBand that has a 
higher resistance.  
To reduce the privacy risk of participants being recorded on video for data 
collection and the possibility of the video recording being lost or exposed, 
all electronic data will be stored using Sharepoint connected to school email 

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addresses with a password. This information will also be kept private by 
utilizing the assigned participant identification numbers.  
Another possible risk of being in this study is a modesty risk that includes 
the exposure of a participant’s buttocks when doing sEMG electrode 
placement for data analysis.  To reduce this modesty risk, an investigator of 
the same sex will be doing the electrode placement. 
One risk associated with sEMG electrode placement includes potential skin 
irritation and a rash occurring from wearing or removing the sEMG 
electrode patches that stick to your skin due to the gel that is used with 
them. Also, the skin will be wiped with an alcohol pad which could cause 
possible irritation as well. If there is hair on the participant’s buttocks, 
irritation or discomfort could occur when the electrode patch is removed. To 
reduce this physical risk, the investigator doing the sEMG electrode 
placement and removal will be careful to avoid causing excessive irritation 
to the skin area and will explain the risks to the participant. 
Upon the first session, the data collection will include participant age, 
height, weight, BMI, dominant LE, in addition to the following pre- and 
post- intervention: FSDT, sEMG from gluteus medius and maximus, 
recorded FSDT video. Compliance chart data will be collected post-
intervention. 
Will any data be shared with the drug/device manufacturer? 
N/A 
• Will you collect any data for patients outside Ochsner Shreveport and 
Monroe (i.e. from sites like New Orleans, Baton Rouge, Lafayette etc.) 
from the databases stated in the protocol?  
Yes ☐     No x 
• 
Please confirm if any data will be transferred to the sites outside 
Ochsner Shreveport & Monroe.  
Yes ☐     No x 
• 
If yes, please list the data that will be transferred and how. 
9.5 N/A 
10.0 Data and Specimen Banking 
10.1 N/A 
10.2 N/A 
10.3 N/A 

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11.0 Data Management and Confidentiality 
11.1 Data analysis plan and statistical procedures. 
FSDT 
Data processing: Each participant will perform a pre- and 
post- intervention trial for the FSDT that will be scored. 
The FSDT consists of 5 repetitions of a step-down task. 
One score is given for the whole test. One raters will score 
the FSDT (MM).  
Data analysis: For the FSDT data, a 2x2 repeated measures 
ANOVA will be performed with significance set at alpha = 
.05. Post hoc testing will be used if significant differences 
are detected with the ANOVA. Tukey’s HSD test will be 
used as the post hoc test, with significance set at alpha = 
.05. 
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 from the FSDT and UPST will 
be normalized to the MVIC obtained during the MVIC 
testing. 
 
Data analysis: Following MVIC normalization, sEMG 
activity will be recorded during each of the outcome 
measures. Each FSDT step-down repetition will be 
analyzed as a separate trial, and the mean and peak 
activation for GMax and GMed will be extracted from each 
of the 5 trials. A mean value for each variable (mean and 
peak activation of GMax, mean and peak activation of 
GMed) will be calculated and recorded at the pre-and post- 
test sessions.  
 
For the sEMG data, a 2x2 repeated measures ANOVA will 
be performed  for each measurement (mean, peak) for each 
muscle (Gmed, Gmax), with significance set at alpha = .05. 
Post hoc testing will be used if significant differences are 
detected with the ANOVA. Tukey’s HSD test will be used 
as the post hoc test, with significance set at alpha = .05. 
 
11.2 G* power (Heinrich-Heine-University Dusseldorf, Dusseldorf, Germany) 
software was used to perform a priori power analysis to determine the 

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required N for this investigation. Data from McCallister Et Al. (2025) study 
reported a Cohen's d of 0.58 (d=0.58).5 An N of 26 was calculated to 
achieve significant results with beta= .80 and alpha =.05 for a two-tailed 
hypothesis from an interaction effect of the 2x2 repeated measures ANOVA. 
Assuming 20% attrition, plus an additional 10% for FSDT screening 
failures, a final N=38 is required for this study.  
11.3 To reduce the risk of loss of confidentiality, participants will be assigned ID 
numbers on their informed consent form. All hardcopy data will be stored in 
a locked drawer in room 2-236 in the SHPS at LSUHS. All electronic data 
will be stored using Sharepoint/OneDrive connected to school email 
addresses with a password. The investigator performing the data analysis 
will be blinded. Participants will be identified by their ID number 
throughout the study, and group assignment will be recorded by ID number. 
A sign-up sheet for data collection times will also use ID number. 
Throughout the study, data will be recorded by ID number on the data 
collection sheet attached to this submission. For the participants to track 
their home exercise sessions, a compliance chart will be created for them 
again with only ID number attached to the compliance chart. 
 
11.4 
The student investigators (DB, GD, MM) will be educated on the proper 
procedures of the FSDT, sEMG data collection, and the HEP by the primary 
investigator (EM) and co-investigator (DF). The FSDT will be analyzed by 
the three student investigators (DB, GD, MM).  The student investigators 
(DB, GD, MM) will record and average their scores for the FSDT following 
the completion of five repetitions to improve the quality of the data. (Super 
script). The sEMG electrodes will be placed on the female participants by 
GD. MM will explain the FSDT procedure to every participant. DB, GD, 
MM will explain the hipactivation exercises on the HEP and will explain the 
movement retraining program HEP and the QR code access for videos.  DB, 
GD, and MM will explain the compliance chart to the participants. The 
primary investigator (EM) is a board-certified orthopedic physical therapist 
with 8 years of experience, who has published research on this test. (super 
script) The co-investigator? (DF) is also a board-certified orthopedic 
physical therapist with 13 years of experience, who also has published 
research on this test with the primary investigator. 
 
11.5 The data that will be collected during the study includesheight, weight, 
BMI, sex, leg dominance, MVIC of each muscle group, FSDT pre and post 
HEP, recorded FSDT video, sEMG from gluteus medius and maximus on 
the dominant leg during FSDT pre and post HEP, and HEP 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 only be 

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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 who will have access to 
this information will be the primary investigator and student investigators 
(EM, DB, GD, MM) since the co-investigator (DF) that is doing the data 
analysis will be blinded.  The primary investigator and student investigators 
are responsible for the receipt and transmission of the data. The student 
investigators (DB, GM, MM) are responsible for data processing. Data will 
be manually transported to EM office room 2-236 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 injuries that affect the ability to complete HEP or FSDT post-
intervention will be withdrawn from the research without their consent.  
13.2 If a participant no longer meets the inclusion or exclusion criteria or if the 
subject notifies the investigator that they no longer wish to continue 
participation in the study, the investigators will notify the participant that 
they have withdrawn from the study and will document the date and reason 
for withdrawal. The participant will return the compliance sheet to the 
investigators. 
13.3 N/A 
14.0 Risks to Subjects 
14.1 As with any exercise program, muscle soreness is a potential side effect. To 
reduce these potential side effects, participants will be asked to make sure 
that they put two days in between completing the HEP. Another risk with 
any exercise program is the potential risk of injury. To reduce these 
potential side effects participants will meet with investigators to be 
instructed on how to perform the exercises safely and will be cued during 
the HEP on proper form to complete the exercises .  
14.2 N/A 
14.3 N/A 
14.4 N/A 
15.0 Potential Benefits to Subjects 
15.1 Potential benefits that individual subjects may experience from taking part 
in this research include improved movement quality and coordination during 
functional tasks. 
15.2 N/A 

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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 N/A 
19.0 Setting 
19.1 Our research team will identify and recruit potential subjects from people 
who are local to Shreveport, LA and local clinical/academic settings. 
• Potential subjects will be recruited via word of mouth on the 
campus of LSUHS and those in the community of Shreveport, LA 
and the surrounding areas.  
• Research procedures will be performed at the SHPS at LSUHS 
main campus in Shreveport, LA. The rehabilitation clinic will be 
used to gather anthropometric measurements and the motion 
analysis lab, room 2-217, will be utilized for sEMG placement and 
FSDT. A separate conference room will be used to assign and 
educate participants on their HEP in order to preserve blinding of 
the data analyst.  
• 
There will not be composition and involvement of any community 
advisory board. There will not be any research conducted outside of 
the organization and its affiliates. 
20.0 Resources Available 
20.1 The three student investigators (GD, DB, and MM) are DPT students in the 
SHSP at LSUHS. They will be educated on the procedures of the FDST 
(reference numbers), sEMG electrode placement, and data collection and 
interpretation (reference number) by primary investigator (EM), who is a 
board-certified orthopedic physical therapist with 9 years of experience and 
the co-investigator (DF), who is a board-certified orthopedic physical 
therapist with 13 years of experience. The primary investigator (EM) and 
co-investigator (DF) have also conducted similar studies previously that 
used the FDST and sEMG data. The primary investigator (EM) and co-
investigator (DF) will assist the student investigators as needed throughout 
the study. Multiple training sessions will occur prior to starting data 
collection to ensure student investigators are reliably able to place sEMG on 
the targeted muscles.  
20.2 In local clinical/academic settings, the total number of first- and second-year 
DPT students currently enrolled in the SHPS at LSUHS is 70. The total 
number of first- and second-year DOT students enrolled in the SHSP is 52. 

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The total number of medical students in the first- and second-year class is 
300. Given the required N = 38, there are enough potential subjects in local 
clinical/academic settings to successfully complete the study.  
• 
Currently, student investigators are enrolled in independent study for 
the Fall 2025 semester to receive IRB approval. The month of January 
2026 will be for recruitment of subjects. Data collection will begin in 
spring of 2026 and will conclude by May 2026. The investigators will 
be enrolled in a 2-credit research course during this semester to allow 
time to conduct the research and work on presenting the research. The 
investigators, EM and DF, will each provide 5% FTE, which is within 
their scholarship FTE distribution considering other research 
commitments. During the Summer 2026 semester, the student 
investigators will begin analyzing the data and dissemination of data. 
All data analysis will be concluded by August 2026. 
• 
The rehabilitation clinic in SHSP at LSUHS, located on the ground 
floor, has scales to measure weight and vertical ruler to measure 
height, and other anthropometric data. The motion analysis lab, room 
2-217 in SHSP at LSUHS has a treatment mat, sEMG materials and 
technology, and an open area to analyze movement. 
• 
Our study has less than minimal risk, thus no medical or psychological 
resources should be needed due to there being no anticipated 
consequences of human research. 
• 
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 Approval for the project will be obtained from the SHPS Associate Dean of 
Business, Technology and Research. 
22.0 Recruitment Methods (Local)  
22.1 Potential subjects will be recruited via word of mouth from people who are 
local to Shreveport, LA and local clinical/academic settings. Investigators 
(DF, GD, DB, and MM) will recruit students on the campus of LSUHS by 
going to different classrooms and informing potential participants about the 
study. A meeting will be held for all potential participants to obtain 
informed consent. Then, once informed consent has been obtained, the 
potential participants will complete a self-reported health questionnaire 
(PAR-Q) and a preliminary FSDT. If a potential participant cannot be 
present at this meeting, a meeting will be scheduled with the investigators to 
obtain informed consent and then the other measures.  
22.2 The subjects will be recruited via word of mouth from people who are local 
to Shreveport, LA and local clinical/academic settings. Participants will be 
considered for participation if they meet all inclusion and exclusion criteria. 
22.3 Potential subjects will first be identified via word of mouth through 
informing students on the campus of LSUHS about the study. 

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22.4 N/A 
22.5 N/A 
23.0 Local Number of Subjects 
23.1 At least 38 subjects will be accrued locally 
23.2 We plan to enroll 38 participants. 
24.0 Provisions to Protect the Privacy Interests of Subjects 
24.1 All individuals participating in the study will be given an identification 
number to protect their personal identity and to maintain single-blind 
confidentiality. Participants will only be expected to interact with the 
investigators (EM, DF, GD, DB, MM) during the study. Participants will 
only be expected to provide personal information to the primary 
investigators (EM, DF) and student investigators (GD, DB, MM).  
24.2 Only the investigators (EM, GD, DB, MM) will be in the room during data 
collection, and any questions will be asked individually with the 
investigators. If another participant is in the room learning the HEP, the 
view will be obstructed with a divider to ensure confidentiality. The co-
investigator (DF) will be asked to leave the room during HEP demonstration 
to each participant to maintain confidentiality. Each participant will be 
asked not to discuss their HEP when co-investigator (DF) is in the room to 
maintain confidentiality. Any written data will refer to participants with 
numbers, not actual names. No previous medical history or identifying 
information will be entered into the data collection. 
24.3 Any information about the subjects will be verbally reported to the 
investigator, except for information regarding their HEP which will not be 
reported to the co-investigator (DF). Recorded data will be placed on a 
master data sheet and will be shared between investigators on 
Sharepoint/OneDrive. Individuals not involved in the investigation will not 
have access to the data. 
25.0 Compensation for Research-Related Injury 
25.1 The study does not involve greater than minimal risk to the subjects. 
25.2 N/A 
26.0 Economic Burden to Subjects 
26.1 There will be no economic burden placed on the participants. Any required 
materials will be provided. The only thing the participants will be 
responsible for is transportation to the facility where the study is conducted 
for data collection. 
27.0 Consent Process (standard operating for informed consent) 
27.1 The consent process will take place in the SHSP at LSUHS in room 3-314. 
There will not be a waiting period between informing prospective subjects 

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and obtaining informed constent. Continued verbal consent will be given 
during FSDT and sEMG processes both before, during, and after HEP. We 
will be using “SOP: Informed Consent Process for Research (HRP-090).” 
28.0 Process to Document Consent in Writing  
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: 
29.1 N/A 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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