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

NCT04938570 | Unknown

• 1 other identifier: RBHS_01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; Sports Injury

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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 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

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northumbria University: lead

Study Sites (1)

Northumbria University

Newcastle upon Tyne, Tyne and Wear, NE7 7XA, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 34936689 DERIVED

MeSH Terms

Conditions

Brain Concussion; Athletic Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Central Study Contacts

Dylan Powell, MSc

CONTACT

01912273343; d.powell@northumbria.ac.uk

Sam Stuart, Phd

CONTACT

01912273343; sam.stuart@northumbria.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: June 24, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-02

Locations

GB (1)