Feasibility and Effectiveness of a Novel Neck Training Device

Injury Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06410846
• Other study ID #: FY22-03
• Status: Recruiting
• Phase: N/A
• Start date: March 5, 2024
• Est. completion date: February 23, 2025

Study information

• Verified date: May 2024
• Source: Landstuhl Regional Medical Center
• Contact: George Smolinski, MD
• Phone: 49-06371-9464-5601
• Email: george.j.smolinski.civ[@]health.mil
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 23, 2025
• Est. primary completion date: February 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Injury Prevention

Intervention

Device:
• TopSpin360
Neck strength and conditioning device used during neck strengthening program.

Other:
• Neck Strengthening Exercise Plan
Physical therapist designed neck strengthening program.

Locations

Country	Name	City	State
Germany	Landstuhl Regional Medical Center	Landstuhl	Rheinland Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
Landstuhl Regional Medical Center	TriService Nursing Research Program

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in neck circumference measurement over time	Describe change in neck measurement (inches) between intervention and control groups and gender. Examiner will use Gulick tape measure at the midcervical spine level at mid-point between the suboccipital junction and the C7 spinous process.	Day 1 and post 12 week exercise follow up visit day
Primary	Change in cervical spine range of motion (ROM) measurements over time	ROM will be measured using smartphone inclinometer and compass measurements of cervical uniplanar (FL/EXT) and multiplanar (rotation) motion .These measurements have been found to be both reliable and 51 valid by Guidetti et.al. (2017) who demonstrated ICC > .99 with minimally detectable change (MDC) of 4-8 degrees and percentage errors between 1-3%.The 52 overcomes the limitation of protractor measurement as a source of error in cervical spine measures as there is no reference to vertical or horizontal, relying on the visual perceptual skills of the examiner and a lack of a standard position.	Day 1 and post 12 week exercise follow up visit day
Primary	Change in Maximum Voluntary Isometric Contraction Testing (MVIC) over time	The hand-held strain gage dynamometer (Lafayette Instruments HHD) will be conducted by the examiner and record the average of 3 trials most representative of best effort. HHD has demonstrated ICCs of .95 between HHD and the gold standard of MVIC measurement using a Cybex isokinetic device in stroke patients and that the make test demonstrated break force ICCs of .981.53 Isokinetic devices (Kin Com and Cybex) and the strain-gage HHD demonstrate a high test-retest reliability (ICC = 0.998) against a known load. MVIC 54 testing using a HHD requires that the examiner elicit the subject's maximum force against the dynamometer and examiner who holds the dynamometer steady. The Lafayette handheld dynamometer utilizes a microprocessor control unit that measures peak force, time to reach peak force, and total test time with an audible tone to indicate the end of preset time. The unit also provides a built-in calibration routine with an internal accuracy of + 1%.	Day 1 and post 12 week exercise follow up visit day
Primary	Change in speed for Peak Revolutions per minute (RPM) over time (TopSpin group only)	An Inflatable pressure biofeedback device is used for the Craniocervical flexion test (CCFT). The CCFT of the deep cervical spine flexors (longus capitus and colli) assesses the activation and isometric endurance of the deep cervical flexors as well as their interaction with the superficial flexors (sternocleidomastoid and anterior scalenes) during five progressive stages of craniocervical flexion, demonstrated 56-58 SCM and AS muscle fatigue during sustained cervical flexion contractions at 25 and 50% of maximum voluntary isometric contraction. Testing will be conducted according to Jull et. al.'s (2008) progressive protocol using a pressure biofeedback device (Figure 5). The CCFT has demonstrated nearly perfect intra-rater (ICC =.98; CI = .99) and inter-rater reliability (ICC = .91). Changes in speed over exercise program will be described.	Day 1 and post 12 week exercise follow up visit day
Primary	Change in speed for completion of 60 revolutions over time (TopSpin group only)	Measure and describe completion of a total of 60 revolutions (30 clockwise and 30 counterclockwise) as quickly as possible. During the test, when the participant completes the first 30 revolutions, they will stop the lever arm in front of their face and then perform the remaining 30 revolutions counterclockwise. The total time is recorded in seconds and is downloaded from the TopSpin app.	Day 1 and post 12 week exercise follow up visit day