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

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.

Study Overview

• Status: Recruiting
• Conditions: Sports Injury; Concussion, Brain

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.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Sam Stuart, PhD; Phone Number: 01912273343; Email: sam.stuart@northumbria.ac.uk
• Study Contact Backup: Name: Dylan Powell, MSc; Phone Number: 01912273343; Email: d.powell@northumbria.ac.uk

Study Locations

• United Kingdom
  • Tyne And Wear
    • Newcastle upon Tyne, Tyne And Wear, United Kingdom, NE7 7XA
      • Recruiting
      • Northumbria University
      • Principal Investigator: Sam Stuart, PhD
      • Contact: Alan Godfrey, PhD; Phone Number: 01912273343; Email: alan.godfrey@northumbria.ac.uk
      • Principal Investigator: Alan Godfrey, PhD
      • Sub-Investigator: Dylan Powell, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

University-level and amateur rugby players; University-level and amateur rugby players will be recruited and assessed (motor, visual and symptom assessment) over one season ( June 2021 to August 2022). Participants will be stratified according to gender (males n≈100, and females n≈100). Although the number of SRC that will be observed during the season is not known, the investigators will compare a number of head injuries/SRC to the results from cohort baseline testing. Participants that do not sustain a concussion will also have follow up testing at the end of the season.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Step time (mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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
Stance time (seconds, mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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
Stride time (seconds, mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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
Swing time (seconds, mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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
Stride length (cm, mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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
Stride velocity (cms-1), mean ± standard deviation)	Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of turns per hour (n, mean ± standard deviation)	Altered free-living, quality-based turning patterns measured by digital intertial wearable	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)	Altered free-living, quality-based turning patterns measured by digital intertial wearable	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))	Altered free-living, quality-based turning patterns measured by digital intertial wearable	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))	Altered free-living, quality-based turning patterns measured by digital intertial wearable	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

Collaborators and Investigators

• Sponsor: Northumbria University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Athletic Injuries; Brain Concussion
• Other Study ID Numbers: RBHS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes