Clinical trial NCT06410846: Feasibility and Effectiveness of a Novel Neck Training Device
Official title: Feasibility and Effectiveness of a Novel Neck Training Device: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Injury Prevention
Lead sponsor: Landstuhl Regional Medical Center
Sponsor class: FED
Collaborators: name: TriService Nursing Research Program
First posted: 2024-05-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in neck circumference measurement over time
timeFrame: Day 1 and post 12 week exercise follow up visit day
measure: Change in cervical spine range of motion (ROM) measurements over time
timeFrame: Day 1 and post 12 week exercise follow up visit day
measure: Change in Maximum Voluntary Isometric Contraction Testing (MVIC) over time
timeFrame: Day 1 and post 12 week exercise follow up visit day
measure: Change in speed for Peak Revolutions per minute (RPM) over time (TopSpin group only)
timeFrame: Day 1 and post 12 week exercise follow up visit day
measure: Change in speed for completion of 60 revolutions over time (TopSpin group only)
timeFrame: Day 1 and post 12 week exercise follow up visit day
Secondary outcomes:
Other outcomes:
Locations:
city: Landstuhl
country: Germany
facility: Landstuhl Regional Medical Center
state: Rheinland Pfalz
Study officials:
affiliation: Martin Army Community Hospital
name: William Brown, PhD
role: STUDY_DIRECTOR
References: