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Recruiting NCT06052553

A Study of TopSpin360 Training Device

No phase Interventional Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TopSpin360.
Who it may be relevant to
Registry conditions: Healthy. Basic parameters: 18 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players

Overview

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

Detailed description

The neck plays a very important role in head positioning, stabilization, and decrease risk and severity. Neck extension strength measure has been associated with a decrease in concussion risk in male rugby players. Neck muscle characteristics may play a vital role in mitigating head accelerations due to contact thus reducing head impact severity. We hypothesize enhanced neuromuscular characteristics of cervical muscles will decrease brain impairments due to repeated contact.

Interventions

  • Device TopSpin360
    Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.

Primary outcome measures

  • Change in peak force [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in normalized peak force [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in force steadiness [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in rate of force development (RFD) [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in visuo-motor reaction time [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in blood biomarker levels [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in salivary biomarkers [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in N100 Amplitude [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in N100 Latency [Time frame: Baseline, post-season (approximately 6 months)]
  • Change in P300 Amplitude [Time frame: Baseline, post-season (approximately 6 months)]
Secondary outcome measures (1)
  • Change in King-Devick Test (KDT) scores [Time frame: Baseline, post-season (approximately 6 months)]

Eligibility criteria

Inclusion criteria

  • Fluent English Speaker.
  • Medically cleared to play ice hockey.

Exclusion criteria

  • Clinically documented hearing issues.
  • In-ear hearing aid or cochlear implant.
  • Implanted pacemaker or defibrillator.
  • Metal or plastic implants in skull. lack of verbal fluency in the English language.
  • History of seizures.
  • Allergy to rubbing alcohol or EEG gel.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06052553 · 23-005197

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗