Muscle Activity During Load Carriage in ROTC Cadets
Primary Purpose
Back Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
load carriage
Sponsored by
About this trial
This is an interventional screening trial for Back Pain
Eligibility Criteria
Inclusion Criteria:
- current enrollment in military science courses and member of Army ROTC
Exclusion Criteria:
- current musculoskeletal injuries
Sites / Locations
- North Dakota State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Without Load
With Load
Arm Description
5 kilometer walk with no load carried
5 kilometer walk with load
Outcomes
Primary Outcome Measures
EMG change over time with Load carriage
muscle activation of rectus femoris, gluteus medius, gluteus maximus, biceps femoris, rectus abdominis, and erector spinae with a 35 lb load
EMG change over time without load
muscle activation of rectus femoris, gluteus medius, gluteus maximus, biceps femoris, rectus abdominis, and erector spinae without a 35 lb load
Modified version of Modified Oswestry Disability Index Current Pain
answers to back pain questionnaire for current level of pain
Modified version of Modified Oswestry Disability Index Pain in Last Year
answers to back pain questionnaire for any pain within the last year
Secondary Outcome Measures
Full Information
NCT ID
NCT04744246
First Posted
May 21, 2020
Last Updated
February 5, 2021
Sponsor
North Dakota State University
1. Study Identification
Unique Protocol Identification Number
NCT04744246
Brief Title
Muscle Activity During Load Carriage in ROTC Cadets
Official Title
An Analysis of Muscle Activity During Load Carriage Activity in Army ROTC Cadets
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 7, 2020 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
November 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
North Dakota State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Army ROTC Cadets who are currently enrolled in Military Science courses will be asked to participate in this experimental research design. A total of 30 healthy cadets consisting of approximately 24 males and six females will be recruited, as this will provide an accurate representation of the overall Army demographics with 17% being female.
Paperwork: After providing consent, participants age and gender will be documented, and height and weight will be measured and documented. Participants will complete a modified version of the Modified Oswestry Low Back Pain Disability Questionnaire, which has been adjusted to be more specific to the military population. The questionnaire will be filled out indicating the cadet's current level of pain. They will then complete the same questionnaire indicating their pain within the last year.
Protocol: First, the skin will be prepared and surface electromyography (EMG) electrodes will be placed. Dynamic, surface EMG data will be obtained of the gluteus medius, gluteus maximus, erector spinae, rectus femoris, and biceps femoris muscles in accordance with SENIAM (Surface Electromyography for the Non-Invasive Assessment of Muscles) guidelines. Skin preparatation will consist of trimming hair if the skin surface at which the electrodes have to be placed is covered with hair. Next, the skin will be cleaned with alcohol. The skin will be allowed to dry prior to electrode placement. Lastly, skin will be abraded to reduce impedance. Following electrode application, participants will complete five minutes of light activity on a bike or treadmill for warm-up. Next, in order to normalize the data, manual muscle tests will be performed for each of the six muscles being test. Then, participants will walk at a speed of four miles per hour for 10 seconds as a dynamic measurement for normalizing the data.
After completion of the two normalization protocols, participants will complete a five kilometer (3.1 mile) walk on a treadmill at a speed of three miles per hour, with and without a 35 lb. load carried in a traditional rucksack. The load conditions will be randomized and counterbalanced in order to mitigate effects of fatigue, and the conditions will be performed in two separate sessions (separated by 24-48 hours).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without Load
Arm Type
Active Comparator
Arm Description
5 kilometer walk with no load carried
Arm Title
With Load
Arm Type
Experimental
Arm Description
5 kilometer walk with load
Intervention Type
Other
Intervention Name(s)
load carriage
Intervention Description
35 pound load carried on the back
Primary Outcome Measure Information:
Title
EMG change over time with Load carriage
Description
muscle activation of rectus femoris, gluteus medius, gluteus maximus, biceps femoris, rectus abdominis, and erector spinae with a 35 lb load
Time Frame
2 days
Title
EMG change over time without load
Description
muscle activation of rectus femoris, gluteus medius, gluteus maximus, biceps femoris, rectus abdominis, and erector spinae without a 35 lb load
Time Frame
2 days
Title
Modified version of Modified Oswestry Disability Index Current Pain
Description
answers to back pain questionnaire for current level of pain
Time Frame
1 day
Title
Modified version of Modified Oswestry Disability Index Pain in Last Year
Description
answers to back pain questionnaire for any pain within the last year
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
current enrollment in military science courses and member of Army ROTC
Exclusion Criteria:
current musculoskeletal injuries
Facility Information:
Facility Name
North Dakota State University
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Muscle Activity During Load Carriage in ROTC Cadets
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