Injury PreventionNCT06410846
Feasibility and Effectiveness of a Novel Neck Training Device
A study testing TopSpin360 and Neck Strengthening Exercise Plan in people with Injury Prevention, run by Landstuhl Regional Medical Center at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Injury Prevention
- What is being tested?
- TopSpin360 and Neck Strengthening Exercise Plan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteGermany
- Study dates
- 5 Mar 2024to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Landstuhl Regional Medical Center
Landstuhl, Rhineland-Palatinate, 66849
About this study
Official title: Feasibility and Effectiveness of a Novel Neck Training Device: A Pilot Study
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.
Read the 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
- Injury Prevention
- Being tested
- TopSpin360, Neck Strengthening Exercise Plan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopSpin360Device
Neck strength and conditioning device used during neck strengthening program.
Neck Strengthening Exercise PlanOther
Physical therapist designed neck strengthening program.
| Study group | Role | What they receive |
|---|---|---|
| TopSpin device | Experimental | TopSpin360 device/neck strengthening exercises. Receives: Device: TopSpin360 |
| Control group | Active comparator | Neck Strengthening exercises. Receives: Other: Neck Strengthening Exercise Plan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 and post 12 week exercise follow up visit day
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.
Measured: Day 1 and post 12 week exercise follow up visit day
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%.
Measured: Day 1 and post 12 week exercise follow up visit day
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.
Measured: Day 1 and post 12 week exercise follow up visit day
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.
Measured: Day 1 and post 12 week exercise follow up visit day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start5 Mar 2024
- Primary completion24 Sep 2025
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Landstuhl Regional Medical Center
- Sponsor type
- US federal agency
- Collaborators
- TriService Nursing Research Program
- Responsible party
- Sponsor
- Investigators
- William Brown, PhD, Study director, Martin Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410846
- Sponsor's protocol ID
- FY22-03
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2024
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Effectiveness of a Novel Neck Training Device: A Pilot Study
- ClinicalTrials.gov ID
- NCT06410846
- Acronym / sponsor ID
- FY22-03
- Conditions
- Injury Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Landstuhl Regional Medical CenterUS federal agency
- Collaborators
- TriService Nursing Research Program
- Study start
- 5 Mar 2024 (actual)
- Primary completion
- 24 Sep 2025 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TopSpin device | Experimental | Device: TopSpin360TopSpin360 device/neck strengthening exercises. |
| Control group | Active comparator | Other: Neck Strengthening Exercise PlanNeck Strengthening exercises. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopSpin360Neck strength and conditioning device used during neck strengthening program. | Device | TopSpin device |
| Neck Strengthening Exercise PlanPhysical therapist designed neck strengthening program. | Other | Control group |
Primary outcome
Change in neck circumference measurement over time
Time frame: Day 1 and post 12 week exercise follow up visit day
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.
Change in cervical spine range of motion (ROM) measurements over time
Time frame: Day 1 and post 12 week exercise follow up visit day
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.
Change in Maximum Voluntary Isometric Contraction Testing (MVIC) over time
Time frame: Day 1 and post 12 week exercise follow up visit day
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%.
Change in speed for Peak Revolutions per minute (RPM) over time (TopSpin group only)
Time frame: Day 1 and post 12 week exercise follow up visit day
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.
Change in speed for completion of 60 revolutions over time (TopSpin group only)
Time frame: Day 1 and post 12 week exercise follow up visit day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Brown, PhD study director
Martin Army Community Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TopSpin360 and Neck Strengthening Exercise Plan in people with Injury Prevention, run by Landstuhl Regional Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neck circumference measurement over time (time frame: Day 1 and post 12 week exercise follow up visit day). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.