Clinical Trials Directory

Trials / Completed

CompletedNCT06410846

Feasibility and Effectiveness of a Novel Neck Training Device

Feasibility and Effectiveness of a Novel Neck Training Device: A Pilot Study

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
46 (actual)
Sponsor
Landstuhl Regional Medical Center · Federal
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

Functional training focusing on dynamic, multiplanar eccentric loading of the neck's complex musculature may provide a unique training effect that may protect against neck injuries and mTBI. The purpose of this study is to test the efficacy and adherence of a 12-week TopSpin360 training regimen on important physiologic and performance outcome measures between an intervention group and a control group. The specific aims are 1) to compare differences in four physiologic neck measures and two TopSpin360 performance measures by group and gender, and 2) to evaluate program adherence.

Detailed description

The study will employ a randomized controlled clinical trial design with pre-and post-exposure testing and comparison of intervention and control groups. Inclusion criteria are active-duty men and women of any rank assigned to LRMC, ages 18-35, own a personal cellphone to download the TopSpin360 App (intervention group), able to attend the two times per week training, and have sufficient time on stations to complete the entire study including post-study measures. Exclusion criteria include any medical profile that prevents full participation in the ACFT, any chronic inner ear abnormalities or history of invasive neck procedures or any gross cervical abnormalities when examined by the staff physical therapist. Study participants in both groups will be measured at baseline and study conclusion. The intervention will use the TopSpin360 device, and the control group will perform a physical therapist designed neck strengthening program. A certified athletic trainer or physical therapist will lead the intervention group for the 12-weeks duration. Data collected will include demographics, physiologic and performance measures, and program adherence.

Conditions

Interventions

TypeNameDescription
DEVICETopSpin360Neck strength and conditioning device used during neck strengthening program.
OTHERNeck Strengthening Exercise PlanPhysical therapist designed neck strengthening program.

Timeline

Start date
2024-03-05
Primary completion
2025-09-24
Completion
2026-02-23
First posted
2024-05-13
Last updated
2026-04-07

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT06410846. Inclusion in this directory is not an endorsement.