A Study of TopSpin360 Training Device

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

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

Conditions
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Healthy

Intervention / Treatment
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* Device: TopSpin360


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Subjects will receive no intervention for the duration of the hockey season. | |
| Experimental: TopSpin360 Intervention Group<br>Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season. | Device: TopSpin360<br>* Helmet training device used to train head to stay stable during jarring impacts through dynamic and multi-planar neck strengthening.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in peak force | Measured by a neck isometric device, maximal load in kilograms that could be applied to head before deviation from neutral position. | Baseline, post-season (approximately 6 months) | 
| Change in normalized peak force | Measured by a neck isometric device, peak force divided by participant weight in kilograms. | Baseline, post-season (approximately 6 months) | 
| Change in force steadiness | Measured by a neck isometric device, average peak force. | Baseline, post-season (approximately 6 months) | 
| Change in rate of force development (RFD) | Automatically collected by the TopSpin360 device, the multi-planar rate of force development (RFD) in pounds of force per second collected in both clockwise and counterclockwise. | Baseline, post-season (approximately 6 months) | 
| Change in visuo-motor reaction time | Measured by a neck isometric device, reported in milliseconds (ms) | Baseline, post-season (approximately 6 months) | 
| Change in blood biomarker levels | Blood will be at a biomarker level. We will investigate 5 different markers: NfL, SNCB, vWF, SNCA, and BDNF. Each biomarker will be measured in Nanograms per Milliliter (ng/ml). | Baseline, post-season (approximately 6 months) | 
| Change in salivary biomarkers | Salivary biomarkers are relatively new and we will investigate to see if NfL, SNCB, vWF, SNCA, and BDNF. Each biomarker will be measured in Nanometer per milliliter (ng/ml). | Baseline, post-season (approximately 6 months) | 
| Change in N100 Amplitude | Electroencephalograph (EEG) recording of brain electrical activity N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. | Baseline, post-season (approximately 6 months) | 
| Change in N100 Latency | Electroencephalograph (EEG) recording of brain electrical activity N100 potential latency. Increased latencies are indicative of slower responses. Obtained by EEG recording of N100 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. | Baseline, post-season (approximately 6 months) | 
| Change in P300 Amplitude | Electroencephalograph (EEG) recording of brain electrical activity P300 potential amplitude. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. | Baseline, post-season (approximately 6 months) | 
| Change in P300 Latency | Electroencephalograph (EEG) recording of brain electrical activity P300 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores | Baseline, post-season (approximately 6 months) | 
| Change in N400 Amplitude | Electroencephalograph (EEG) recording of brain electrical activity N400 potential amplitude. Increased amplitudes are indicative of larger signals. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. | Baseline, post-season (approximately 6 months) | 
| Change in N400 Latency | Electroencephalograph (EEG) recording of brain electrical activity N400 potential latency. Increased latencies are indicative of slower responses. This measures is subsequently linearly transformed to a standardized score on a 0-100 scale, with larger peak amplitudes and shorter peak latencies resulting in higher scores. | Baseline, post-season (approximately 6 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in King-Devick Test (KDT) scores | A rapid number-naming test that requires individuals to read 3 numbered patters aloud as fast as possible, the resulting time if the KDT score. The post-season score is compared to the pre-season baseline. An increase in the number of seconds required to read the 3 number patterns is considered to be significant. | Baseline, post-season (approximately 6 months) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ice Hockey