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临床试验/NCT04938570
NCT04938570Unknown不适用

Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment

Northumbria University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Stride velocity (cms-1), mean ± standard deviation)

研究概览

简要总结

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (symptom, cognitive, visual, motor). The investigators aim to recruit 200 rugby players (male and female) from University Rugby Union teams and local amateur rugby clubs in the North East of England. The multimodal battery assessment used in this study will compare metrics between digital methods and against traditional assessment.

详细描述

Background:

Pragmatic challenges remain in the monitoring and return to play (RTP) decisions following suspected Sports Related Concussion (SRC). Reliance on traditional approaches (pen and paper) means players readiness for RTP is often based on self-reported symptom recognition as a marker for full physiological recovery. Non-digital approaches also limit opportunity for robust data analysis which may hinder understanding of the interconnected nature and relationships in deficit recovery. Digital approaches may provide more objectivity to measure and monitor impairments in SRC. Crucially, there is dearth of protocols for SRC assessment and digital devices have yet to be tested concurrently (multimodal) in SRC rugby union assessment. Here the investigators propose a multimodal protocol for digital assessment in SRC, which could be used to enhance traditional sports concussion assessment approach.

Methods:

The investigators aim to use a repeated measures observational study utilising a battery of multimodal assessment tools (symptom, cognitive, visual, motor). The investigators aim to recruit 200 rugby players (male and female) from University Rugby Union teams and local amateur rugby clubs in the North East of England. The multimodal battery assessment used in this study will compare metrics between digital methods and against traditional assessment.

Conclusion: This paper outlines a protocol for a multimodal approach for the use of digital technologies to augment traditional approaches to SRC, which may better inform RTP in rugby union. Findings may shed light on the new ways of working with digital tools in SRC. Multimodal approaches may enhance understanding of the interconnected nature of impairments and provide scalable, more objective assessment and RTP in SRC.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years;
  • Have minimal cognitive impairment, defined as a score between 0 and 8 on the Short Blessed test for cognitive function;
  • English as a first language or fluency.
  • Those that have an mTBI/Concussion during the season must have a diagnosis of mTBI from a healthcare professional (physiotherapist or medic) based upon standard criteria or identified head injury from contact sport.

排除标准

  • Medical history of a neurological illness that could grossly affect balance or coordination (such as. stroke, greater than mild TBI, lower-extremity amputation, recent lower extremity or spine orthopaedic injury requiring a profile).
  • Be a pregnant female
  • Have past history of peripheral vestibular pathology or eye movement deficits.
  • Be unable to abstain from medication/alcohol 24 hours in advance of testing

结局指标

主要结局

Stride velocity (cms-1), mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

Swing time (seconds, mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

Step time (mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

Stance time (seconds, mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

Stride time (seconds, mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

Stride length (cm, mean ± standard deviation)

时间窗: Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months

Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable

次要结局

  • Number of turns per hour (n, mean ± standard deviation)(Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months)
  • Turn duration (seconds, mean ± standard deviation))(Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months)
  • Turn velocity (°/seconds, mean ± standard deviation))(Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months)
  • Turn angle (°, mean ± standard deviation)(Participants diagnosed with SRC will be asked to attend a laboratory session/free living assessment at the following subsequent time frames post injury; within 72 hours post, 7-14 days post, within 30 days and 3-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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