TopSpin360 Device for Neck Strength and Brain Function Improvement

Overseen By Houston Hawkins

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Hearing issues, Seizures, Implants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Approximately 6 months

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive function.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the TopSpin360 treatment for neck strength and brain function improvement?

The study on VR gamification for neck rehabilitation shows that virtual reality exercises can effectively prompt neck movements suitable for rehabilitation, which suggests that similar technology-based treatments like TopSpin360 might also be beneficial for neck strength improvement. ^{1 2 3 4 5}

How does the TopSpin360 device treatment differ from other neck strength and brain function treatments?

The TopSpin360 device is unique because it uses self-generated centripetal force to create dynamic rotational resistance, targeting the neck muscles' ability to perform coordinated multiplanar contractions. This approach is different from traditional neck strengthening methods, which typically focus on straight-plane, isotonic exercises. ^{1 2 6 7 8}

Research Team

Mario Hevesi, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for healthy individuals who are medically cleared to play ice hockey and can speak English fluently. It's not suitable for those with pacemakers, hearing issues, skull implants, seizure history, or allergies to rubbing alcohol or EEG gel.

Inclusion Criteria

Medically cleared to play ice hockey

Fluent English Speaker

Exclusion Criteria

You are allergic to rubbing alcohol or the gel used for EEG testing.

Implanted pacemaker or defibrillator

I am not fluent in English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the TopSpin360 device twice-weekly for the duration of the hockey season

Approximately 6 months

Follow-up

Participants are monitored for changes in biomarkers and cognitive measures post-season

4 weeks

Treatment Details

Interventions

• TopSpin360

Trial Overview The study is examining the TopSpin360 training device to see if it improves neck strength and cognitive function in participants who are active ice hockey players.

Participant Groups

Group I: TopSpin360 Intervention Group Experimental Treatment 1 Intervention

Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season.

Group II: Control Group Active Control 1 Intervention

Subjects will receive no intervention for the duration of the hockey season.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study involving 20 healthy participants, a fully immersive virtual reality game (VRPhysio) successfully prompted neck movements that were identified by physiotherapists as appropriate rehabilitation exercises.

No adverse events were reported during the session, suggesting that VR gamification could be a safe and effective method for encouraging adherence to neck rehabilitation exercises, warranting further evaluation in randomized controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? Gavish, L., Weissberger, O., Barzilay, Y.[2023]

In a study involving 152 participants with neck pain, combining local neck treatment with joint position sense (JPS) and balance exercises led to the most significant improvements in proprioception and balance, with medium to large effect sizes observed.

All treatment combinations resulted in both short- and long-term benefits for neck pain, dizziness, and related symptoms, but the addition of sensorimotor training helped maintain these improvements over 6 to 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adding rehabilitation of cervical related sensorimotor control to manual therapy and exercise for neck pain: A randomized controlled trial. Sremakaew, M., Jull, G., Treleaven, J., et al.[2023]

In a study of 55 participants with chronic neck pain, McKenzie exercises combined with traditional physical therapy led to significantly greater improvements in pain severity, cervical mobility, and functional disability compared to deep neck flexor (DNF) exercises combined with scapulothoracic exercises.

Both exercise interventions resulted in reduced neck pain and increased range of motion, but the McKenzie group showed superior outcomes over the DNF group and the control group after 6 weeks of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. Abdel-Aziem, AA., Mohamed, RR., Draz, AH., et al.[2022]

The CROM device demonstrated the highest reliability for measuring cervical range of motion in patients with neck pain, showing excellent reliability overall except for moderate reliability in right rotation.

iPhone applications for measuring cervical range of motion provided good to excellent reliability, making them a viable option for clinical use, while Android applications showed inconsistent reliability and are not recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone Applications as a Suitable Alternative to CROM Device and Inclinometers in Assessing the Cervical Range of Motion in Patients With Nonspecific Neck Pain. Ghorbani, F., Kamyab, M., Azadinia, F.[2022]

The Patient-Specific Functional Scale demonstrated excellent reliability (R = .92) and validity (correlation coefficients ranging from r = .73 to .83) when assessing disability in 31 patients with neck dysfunction, indicating it is a trustworthy tool for measuring patient outcomes.

The scale was sensitive to changes in disability over time, showing strong correlations with other established measures, and was equally effective as the Neck Disability Index in detecting changes, supporting its use in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The patient-specific functional scale: validation of its use in persons with neck dysfunction. Westaway, MD., Stratford, PW., Binkley, JM.[2022]

The NSE-1 neck training machine effectively increased neck strength in air force pilots, with improvements of up to 83.7% in various neck movements after 6 weeks of training.

The training was conducted safely and effectively, utilizing advanced technologies like adaptive hydraulics and biological feedback to optimize resistance and velocity during exercises.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Research, design and application of model NSE-1 neck muscle training machine for pilots]. Cheng, H., Wang, Z., Liu, S., et al.[2011]

The new test for detecting neck movement accuracy showed better reliability in asymptomatic individuals compared to those with chronic whiplash-associated disorders (WAD), indicating it may be more effective for assessing healthy neck function.

The test successfully discriminated between the two groups, revealing that individuals with chronic WAD had poorer performance in neck movement accuracy, which could help in evaluating and treating neck pain conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new clinical test for cervicocephalic kinesthetic sensibility: "the fly". Kristjansson, E., Hardardottir, L., Asmundardottir, M., et al.[2019]

A pilot study involving 18 participants (8 in the intervention group and 10 in the control group) demonstrated that a novel neuromuscular neck training device significantly improved dynamic and static neck strength after 7 weeks of training, with peak revolutions per minute (RPM) increasing from 122.8 to 252.3.

The intervention group showed a large positive effect in isometric neck strength, particularly in axial rotation, suggesting that this training could enhance neck muscle coordination and potentially reduce the risk of injuries like concussions and whiplash.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effects of a Novel Neuromuscular Neck Training Device on Multiplanar Static and Dynamic Neck Strength: A Pilot Study. Versteegh, TH., Dickey, JP., Emery, CA., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Gamification of Cervical Spine Physiotherapy by Virtual Reality Software: Is This Real Rehabilitation? [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Effectiveness of adding rehabilitation of cervical related sensorimotor control to manual therapy and exercise for neck pain: A randomized controlled trial. [2023]

3. Italy pubmed.ncbi.nlm.nih.gov

The effect of McKenzie protocol vs. deep neck flexor and scapulothoracic exercises in subjects with chronic neck pain - a randomized controlled study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Smartphone Applications as a Suitable Alternative to CROM Device and Inclinometers in Assessing the Cervical Range of Motion in Patients With Nonspecific Neck Pain. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The patient-specific functional scale: validation of its use in persons with neck dysfunction. [2022]

6. China pubmed.ncbi.nlm.nih.gov

[Research, design and application of model NSE-1 neck muscle training machine for pilots]. [2011]

7. United States pubmed.ncbi.nlm.nih.gov

A new clinical test for cervicocephalic kinesthetic sensibility: "the fly". [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating the Effects of a Novel Neuromuscular Neck Training Device on Multiplanar Static and Dynamic Neck Strength: A Pilot Study. [2021]