Improving Core Strength in the Warfighter with a Novel Device

Not Applicable

Active, not recruiting

• Conditions: Core Strengthening; Posture; Low Back Pain

• Registration Number: NCT06797830
• Lead Sponsor: David Moss

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.

Detailed Description

Trunk control enables the body to stay upright while sitting and standing. Trunk muscles also respond to shifting weight during activity in order to keep the body balanced and to prevent falling over due to shifts in center-of-gravity. Trunk control is necessary to perform activities of daily living and to stave off low back pain to ensure servicemember optimal performance. Weakened trunk muscles are a symptom of conditions such as cerebral palsy and stroke as well as causing more common conditions such as low back pain (Karthikbabu; Emami). Military pilots with weak core muscles were associated with having significant low back pain (Yang). Chinese military recruits assigned to core muscle functional strength training intervention had half as many reports of low back pain as the control group and also reported increased lumbar endurance (Wang). After 9 weeks, military police officers given trunk training had significantly lower general musculoskeletal pain than control as well as increased trunk muscle endurance (Grani). A systematic review in 2021 concluded that core stability provides therapeutic effects in patients with nonspecific low back pain by reducing pain and disability and by improving quality of life measures (Frizziero).

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). AllCore360° can be individualized so that the patient is sitting at a specific degree (0° to 90°), where lowering the degree increases the difficulty of keeping muscles activated to continuecorrect posture. Once secured to the machine, the patient spends a pre-specified number of minutes with their whole body spinning in a 360° arc at the pre-specified angle programmed into the machine, rotating clockwise, counter-clockwise, or both.

AllCore360° is a relatively new machine outside of high-performance sports and intense rehab, and as such there is little published literature evaluating it. Case reports do exist. One case report showed the impact a 14-week program of AllCore360° isometric trunk training had on a child with cerebral palsy, where upon completion the patient had improved trunk stability and motor function (Park). Another case series looked at the AllCore360°'s effect on trunk function, balance, and mobility after stroke, finding improved lateral control during standing and showing that an extended program of AllCore360° sessions is feasible and repeatable (Pilkar).

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-21
• Study First Submitted: 2025-01-21
• Study First Submitted QC: 2025-01-21
• Last Update Submitted: 2025-01-21
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Primary Completion: 2027-01
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Posture	baseline/week 1 (visit 1), week 4 (visit 12), week 7 (visit 13)	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.
Core Strength	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)	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.

Secondary Outcome Measures

Name	Time	Method
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)	Providers will also evaluate participants core strength by recording the AllCore degree settings of each subject at each visit. The AllCore ranges from 0° to 90° and it can be adjusted at each visit according to the subject's core strength. This will be measured at every visit for a total of 13 times.

Trial Locations

Locations (1)

Mike O'Callaghan Military Medical Center; 🇺🇸 Nellis AFB, Nevada, United States