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

Concussion, Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04938570
• Other study ID #: RBHS_01
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: August 2022

Study information

• Verified date: February 2022
• Source: Northumbria University
• Contact: Dylan Powell, MSc
• Phone: 01912273343
• Email: d.powell[@]northumbria.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Concussion, Brain
• Sports Injury

Locations

Country	Name	City	State
United Kingdom	Northumbria University	Newcastle upon Tyne	Tyne And Wear

Sponsors (1)

Lead Sponsor	Collaborator
Northumbria University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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