Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06410846
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-04-15
Brief Title:
Feasibility and Effectiveness of a Novel Neck Training Device
Sponsor:
Landstuhl Regional Medical Center
Organization:
Landstuhl Regional Medical Center
Study Overview
Official Title:
Feasibility and Effectiveness of a Novel Neck Training Device A Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Functional training focusing on dynamic multiplanar eccentric loading of the necks 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None