Improving Core Strength in the Warfighter With a Novel Device

NCT06797830 | Active Not Recruiting DMC

• 1 other identifier: NMCSD.2025.0010
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is one of the most common chief complaints amongst adult patients in the ambulatory clinic and emergency settings and poor core strength is a known underlying cause/perpetuator. Additionally, it is one of the most common reasons active-duty military personnel seek medical care (absolute 2015; absolute 2016; absolute 2017). Moreover, musculoskeletal conditions represent a common reason service members are placed on limited duty and considered medically not fit to deploy. The AllCore360° has the potential to prevent pain and injury, decrease pain as well as reduce duty, fitness and mobility restrictions in active-duty members with low back pain.

Conditions

Core Strengthening; Posture; Low Back Pain

Keywords

AllCore

Outcome Measures

Primary Outcomes (2)

• Posture

  Providers will evaluate participants posture using the PostureScreen® mobile app. The PostureScreen® mobile app can be loaded onto an iPad or phone and used by study personnel to take photos of the subject. The software then measures postures from multiple views and produces a total of 41 with the spine data (31 without the spine data) postural measurements. These measurements are reported as anterior/lateral translations and angular displacements in a scale of inches or degrees respectively. A translation or angulation of 0 would indicate no postural displacement for that specific measure. This will be measured a total of 3 times over the course of the study.

  baseline/week 1 (visit 1), week 4 (visit 12), week 7 (visit 13)

• Core Strength

  Providers will evaluate participants core strength using sEMG measurement taken by DynaROM™ Motion EMG developed by Myovision. DynaROM™ uses sEMG to measure contractile strength in microvolts (μV) of underlying the muscles during contraction. Strength of contraction of the oblique muscles and lumbar paraspinous muscles will be measured by leads placed over these respective muscle groups. Strength on muscle contractions will be recorded every 10th of a second for the entire 10-minute session. A measurement of 0 would indicate no muscle contraction. This will be measured at every visit for a total of 13 times.

  visit 1 (week), visit 2 (week 1), visit 3 (week 1); visit 4 (week 2), visit 5 (week 2), visit 6 (week 2); visit 7 (week 3), visit 8 (week 3), visit 9 (week 3); visit 10 (week 4), visit 11 (week 4), visit 12 (week 4); visit 13 (week 7)

Secondary Outcomes (1)

• Core Strength -- AllCore degree setting

  visit 1 (week), visit 2 (week 1), visit 3 (week 1); visit 4 (week 2), visit 5 (week 2), visit 6 (week 2); visit 7 (week 3), visit 8 (week 3), visit 9 (week 3); visit 10 (week 4), visit 11 (week 4), visit 12 (week 4); visit 13 (week 7)

Study Arms (1)

Cohort

EXPERIMENTAL

This is a prospective observational cohort using pre and post measurements of posture and core strength in subjects (Active Duty Members enrolled in Tactical Air Control Party Training) treated consistently with the AllCore360. The patients will act as their own control.

Device: AllCore

Interventions

AllCore DEVICE

AllCore360° is a novel core-strengthening machine intervention designed to target trunk muscles through gravity by means of high-intensity constant velocity rotating exercise (allcore360.com). AllCore360° is systematic, consistent and designed for use over time. The core is strengthened because a patient's core muscles are used in anterior, lateral, and posterior contractions sequentially during a single rotation (Palevo). The patient must resist gravity with the rotation as well as contract and fire isometrically to keep proper posture. Using proper posture, the patient must keep their back straight and neck neutral throughout the length of the intervention without relying on their lower body muscles at all (this is assisted by straps rendering the legs useless and by securing the pelvis in the chair).

Cohort

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy DoD beneficiaries at Nellis Air Force Base between the ages of 18 and 50 participating in Tactical Air Control Party Specialist (TACP) training program

You may not qualify if:

• Legally Authorized Representatives will not be utilized in this study.
• Current low back pain
• history of spinal surgery
• history of other serious spinal pathology (e.g. annular tears, spinal stenosis \[canal or neuroforaminal\], fracture, painful spinal arthritis)
• pregnancy

Sponsors & Collaborators

• David Moss: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (15)

• Boland DM, Neufeld EV, Ruddell J, Dolezal BA, Cooper CB. Inter- and intra-rater agreement of static posture analysis using a mobile application. J Phys Ther Sci. 2016 Dec;28(12):3398-3402. doi: 10.1589/jpts.28.3398. Epub 2016 Dec 27.

  PMID: 28174460 BACKGROUND

• Cleland CL, Hunter RF, Kee F, Cupples ME, Sallis JF, Tully MA. Validity of the global physical activity questionnaire (GPAQ) in assessing levels and change in moderate-vigorous physical activity and sedentary behaviour. BMC Public Health. 2014 Dec 10;14:1255. doi: 10.1186/1471-2458-14-1255.

  PMID: 25492375 BACKGROUND

• Clark LL, Hu Z. Diagnoses of low back pain, active component, U.S. Armed Forces, 2010-2014. MSMR. 2015 Dec;22(12):8-11.

  PMID: 26726722 BACKGROUND

• Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2015. MSMR. 2016 Apr;23(4):2-7. No abstract available.

  PMID: 27152681 BACKGROUND

• Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2016. MSMR. 2017 Apr;24(4):2-8. No abstract available.

  PMID: 28488875 BACKGROUND

• Pilkar R, Veerubhotla A, Ibironke O, Ehrenberg N. A Novel Core Strengthening Intervention for Improving Trunk Function, Balance and Mobility after Stroke. Brain Sci. 2022 May 20;12(5):668. doi: 10.3390/brainsci12050668.

  PMID: 35625054 BACKGROUND

• Armed Forces Health Surveillance Branch. Absolute and relative morbidity burdens attributable to various illnesses and injuries, active component, U.S. Armed Forces, 2017. MSMR. 2018 May;25(5):2-9. No abstract available.

  PMID: 29799210 BACKGROUND

• Park, Eunse and Castle, Kimberly (2021) "The effect of an isometric trunk training during spinning in a child with Cerebral Palsy: A case report," Interprofessional Journal of Healthcare and Research: Vol. 1 , Article 4.

  BACKGROUND

• Palevo, Gregory et al. Physiological Responses to Allcore360º Core Training System. Journal of Exercise Physiology. April 2022. Vol 24 Num 2.

  BACKGROUND

• Grani G, Rodacki CLN, Lubas H, Resende EF, Hoinatski R, Sentone RG, Orr R, Paulo AC. Can training trunk musculature influence musculoskeletal pain and physical performance in military police officers? Ergonomics. 2022 Feb;65(2):265-275. doi: 10.1080/00140139.2021.1973576. Epub 2021 Sep 8.

  PMID: 34445935 BACKGROUND

• Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.

  PMID: 33922389 BACKGROUND

• Wang X, Song WJ, Ruan Y, Li BC, Lu C, Huang N, Fang FF, Gu W. Core muscle functional strength training for reducing the risk of low back pain in military recruits: An open-label randomized controlled trial. J Integr Med. 2022 Mar;20(2):145-152. doi: 10.1016/j.joim.2021.12.002. Epub 2021 Dec 16.

  PMID: 34969649 BACKGROUND

• Yang Y, Liu S, Ling M, Ye C. Prevalence and Potential Risk Factors for Occupational Low Back Pain Among Male Military Pilots: A Study Based on Questionnaire and Physical Function Assessment. Front Public Health. 2022 Jan 4;9:744601. doi: 10.3389/fpubh.2021.744601. eCollection 2021.

  PMID: 35059371 BACKGROUND

• Emami F, Yoosefinejad AK, Razeghi M. Correlations between core muscle geometry, pain intensity, functional disability and postural balance in patients with nonspecific mechanical low back pain. Med Eng Phys. 2018 Oct;60:39-46. doi: 10.1016/j.medengphy.2018.07.006. Epub 2018 Aug 1.

  PMID: 30077486 BACKGROUND

• Karthikbabu S, Verheyden G. Relationship between trunk control, core muscle strength and balance confidence in community-dwelling patients with chronic stroke. Top Stroke Rehabil. 2021 Mar;28(2):88-95. doi: 10.1080/10749357.2020.1783896. Epub 2020 Jun 23.

  PMID: 32574524 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective observational cohort using pre and post measurements of posture and core strength in subjects treated consistently with the AllCore360. The patients will act as their own control.

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: January 29, 2025
• Study Start: January 21, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)