The Effectiveness of a Novel Neck Training Device on Objective Neck Strength and Cognitive Measures in Junior A Hockey Players
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in peak force
研究概览
简要总结
This research is being done to investigate the novel neck strengthening device, TopSpin360 and its effectiveness on measures of neck strength and cognitive function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fluent English Speaker.
- •Medically cleared to play ice hockey.
排除标准
- •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.
研究组 & 干预措施
Control Group
Subjects will receive no intervention for the duration of the hockey season.
TopSpin360 Intervention Group
Subjects will use TopSpin360, twice- weekly and use for the duration of the hockey season.
干预措施: TopSpin360 (Device)
结局指标
主要结局
Change in peak force
时间窗: Baseline, post-season (approximately 6 months)
Measured by a neck isometric device, maximal load in kilograms that could be applied to head before deviation from neutral position.
Change in normalized peak force
时间窗: Baseline, post-season (approximately 6 months)
Measured by a neck isometric device, peak force divided by participant weight in kilograms.
Change in force steadiness
时间窗: Baseline, post-season (approximately 6 months)
Measured by a neck isometric device, average peak force.
Change in N100 Latency
时间窗: Baseline, post-season (approximately 6 months)
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.
Change in P300 Amplitude
时间窗: Baseline, post-season (approximately 6 months)
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.
Change in rate of force development (RFD)
时间窗: Baseline, post-season (approximately 6 months)
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.
Change in visuo-motor reaction time
时间窗: Baseline, post-season (approximately 6 months)
Measured by a neck isometric device, reported in milliseconds (ms)
Change in blood biomarker levels
时间窗: Baseline, post-season (approximately 6 months)
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).
Change in salivary biomarkers
时间窗: Baseline, post-season (approximately 6 months)
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).
Change in N100 Amplitude
时间窗: Baseline, post-season (approximately 6 months)
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.
Change in P300 Latency
时间窗: Baseline, post-season (approximately 6 months)
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
Change in N400 Amplitude
时间窗: Baseline, post-season (approximately 6 months)
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.
Change in N400 Latency
时间窗: Baseline, post-season (approximately 6 months)
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.
次要结局
- Change in King-Devick Test (KDT) scores(Baseline, post-season (approximately 6 months))