Concussion, BrainNCT04938570
Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment
An observational study of Concussion, Brain and Sports Injury, run by Northumbria University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Sports Injury
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2021to Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE7 7XA
Alan Godfrey, PhD, 01912273343, alan.godfrey@northumbria.ac.uk
Alan Godfrey, PhD
About this study
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.
Read the 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.
- Conditions
- Concussion, Brain, Sports Injury
- Medical subject headings
- Brain Concussion, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Step time (mean ± standard deviation)
Altered free-living, quality-based gait/walking patterns measured by digital intertial wearable
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Altered free-living, quality-based turning patterns measured by digital intertial wearable
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Jun 2021
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938570
- Sponsor's protocol ID
- RBHS_01
- Status last verified
- Feb 2022
- First submitted
- 18 May 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 34936689
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wearables in Rugby Union: A Protocol for Multimodal Digital Sports-related Concussion Assessment
- ClinicalTrials.gov ID
- NCT04938570
- Acronym / sponsor ID
- RBHS_01
- Conditions
- Concussion, Brain, Sports Injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 24 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 18 years;
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Step time (mean ± standard deviation)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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 velocity (cms-1), mean ± standard deviation)
Time frame: 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
4 secondary outcomes
Number of turns per hour (n, mean ± standard deviation)
Time frame: 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)
Time frame: 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))
Time frame: 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))
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Derived from this study: PubMed 34936689Powell 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Sports Injury, run by Northumbria University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dylan Powell, MSc (01912273343, d.powell@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step time (mean ± standard deviation) (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04938570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.