NCT04744246

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

September 7, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2020

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 8, 2021

Completed
Last Updated

February 8, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

May 21, 2020

Last Update Submit

February 5, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

    2 days

  • 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

    2 days

  • Modified version of Modified Oswestry Disability Index Current Pain

    answers to back pain questionnaire for current level of pain

    1 day

  • Modified version of Modified Oswestry Disability Index Pain in Last Year

    answers to back pain questionnaire for any pain within the last year

    1 day

Study Arms (2)

Without Load

ACTIVE COMPARATOR

5 kilometer walk with no load carried

Other: load carriage

With Load

EXPERIMENTAL

5 kilometer walk with load

Other: load carriage

Interventions

35 pound load carried on the back

With LoadWithout Load

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • current enrollment in military science courses and member of Army ROTC

You may not qualify if:

  • current musculoskeletal injuries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Dakota State University

Fargo, North Dakota, 58108, United States

Location

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2020

First Posted

February 8, 2021

Study Start

September 7, 2020

Primary Completion

October 29, 2020

Study Completion

November 1, 2020

Last Updated

February 8, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations