Clinical trial NCT04938570: Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment
Official title: Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Concussion, Brain
Sports Injury
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2021-06-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: University-level and amateur rugby players (males n≈100, and females n≈100) will be recruited and assessed over one season (June 2021 to August 2022). Participants will be stratified according to gender (males and females). Although the number of SRC that will be observed during the season is not known, investigators will compare number of head injuries/SRC to results from cohort baseline testing. Participants that do not sustain a concussion will also have follow up testing at the end of the season

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Step time (mean ± standard deviation)
timeFrame: 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
measure: Stance time (seconds, mean ± standard deviation)
timeFrame: 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
measure: Stride time (seconds, mean ± standard deviation)
timeFrame: 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
measure: Swing time (seconds, mean ± standard deviation)
timeFrame: 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
measure: Stride length (cm, mean ± standard deviation)
timeFrame: 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
measure: Stride velocity (cms-1), mean ± standard deviation)
timeFrame: 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
Secondary outcomes:
measure: Number of turns per hour (n, mean ± standard deviation)
timeFrame: 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
measure: Turn angle (°, mean ± standard deviation)
timeFrame: 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
measure: Turn duration (seconds, mean ± standard deviation))
timeFrame: 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
measure: Turn velocity (°/seconds, mean ± standard deviation))
timeFrame: 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
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne And Wear
Study officials:
References:
citation: Powell D, Stuart S, Godfrey A. Wearables in rugby union: A protocol for multimodal digital sports-related concussion assessment. PLoS One. 2021 Dec 22;16(12):e0261616. doi: 10.1371/journal.pone.0261616. eCollection 2021.