Feasibility and Effectiveness of a Novel Neck Training Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-05

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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

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Injury Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TopSpin device

TopSpin360 device/neck strengthening exercises.

Group Type EXPERIMENTAL

TopSpin360

Intervention Type DEVICE

Neck strength and conditioning device used during neck strengthening program.

Control group

Neck Strengthening exercises.

Group Type ACTIVE_COMPARATOR

Neck Strengthening Exercise Plan

Intervention Type OTHER

Physical therapist designed neck strengthening program.

Interventions

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TopSpin360

Neck strength and conditioning device used during neck strengthening program.

Intervention Type DEVICE

Neck Strengthening Exercise Plan

Physical therapist designed neck strengthening program.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy active-duty service members of any military rank assigned to LRMC
* 18-35 years old
* assigned to Landstuhl Regional Medical Center
* own a personal cellphone to download the TopSpin360 App (intervention group)
* able to attend the two times per week training
* have sufficient time on station to complete entire study including post-study measures.

Exclusion Criteria

* any medical profile that prevents full participation in the ACFT
* any chronic inner ear abnormalities (e.g., Meniere's disease or benign positional vertigo)
* history of invasive neck procedures (cortisone injections or neck surgery)
* any known cervical spine disorders (e.g., degenerative changes of the cervical spine) or gross cervical spine abnormalities when examined by the staff physical therapist
* non-US military personnel, i.e., German or Netherlands military personnel etc.

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes