Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001707853
Ethics application status
Approved
Date submitted
9/11/2021
Date registered
13/12/2021
Date last updated
18/11/2022
Date data sharing statement initially provided
13/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Concussion in Sport- Head Pulse
Scientific title
Diagnostic Accuracy of Head Pulse Measurement for Concussion compared to the clinical diagnosis following head injury among Australian footballers.
Secondary ID [1] 305752 0
Nil
Universal Trial Number (UTN)
U1111-1271-3433
Trial acronym
HPC
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Concussion 324245 0
Brain Functionality After Concussion 324246 0
Condition category
Condition code
Neurological 321740 321740 0 0
Other neurological disorders
Injuries and Accidents 321945 321945 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A head pulse device will be placed on the participant and a head pulse recording will be obtained. The duration of each recording is approximately 3-5 minutes, with the entire procedure including information gathering taking around 15 minutes.
For concussed participants, these tests will be conducted on game day at the venue that they are competing at.
Self report symptom inventory and neurobehavioural tests including Sport Concussion Assessment Tool (SCAT) questions will be completed and results will be entered into a secure database for analysis.
Concussed participants will be required to be tested daily for two weeks and then 3 times per week in weeks 3 and 4 after the concussion occurring, to measure their recovery.
Trained University Graduates will perform the testing.
Intervention code [1] 322154 0
Diagnosis / Prognosis
Comparator / control treatment
Concussed participants will be measured and results compared with the brain functionality of non-concussed control participants.
The non-concussed participants will be tested 15 times throughout the 6 month study period, with the duration of each recording being 3-5 minutes. These tests will be conducted fortnightly at the training venue.
The Head Pulse recordings of the concussed participants will also be compared to the results of the standard Sport Concussion Assessment Tool (SCAT) test, which are performed by the teams medical staff as part of the diagnostic process in the moments immediately following the injury occurring.
Control group
Active

Outcomes
Primary outcome [1] 329495 0
The primary outcome of this interventional study is to document the diagnostic accuracy of the headpulse device for concussion compared to the clinical diagnosis for measurements made following injury.
Participants will have accelerometry measurements and concurrent 3 lead Electrocardiograms, with the main outcome measure being whether a characteristic waveform pattern of cranial accelerometry occurs with participants with concussion.
Timepoint [1] 329495 0
Initial recording of concussed participant taken within 60 minutes of the injury occurring.
Daily recordings taken for 2 weeks following the injury.
3 recordings per week for weeks 3 and 4 following the injury.



Update reports will be prepared and reviewed by the researchers fortnightly, through the study period
Primary outcome [2] 329496 0
A primary outcome of this observational study is to document the brain's recovery from concussion in the days immediately following the injury, when compared to standard neurological clinical testing methods.
The subjective results of the concussed participants SCAT test, which is performed immediately following the injury, and the Symptom Indicator questions which are asked each time a recording is taken, are compared to the objective results obtained from the Head Pulse measurement device. These recordings track the brains recovery in the days following the injury. The recordings are also compared to the cumulative 'normal' readings of the control group (non-concussed participants) to clearly highlight the 'abnormal' readings of concussed participants.
Timepoint [2] 329496 0
Both concussed and non-concussed participants will have multiple sequential recordings taken.
Concussed participants will be measured within 60 minutes of the injury occurring, then daily for the following two weeks. In weeks 3 and 4, three recordings per week will be taken.

Non- concussed participants will be tested fortnightly for a minimum of 15 times throughout the 6 month study period.
Secondary outcome [1] 402785 0
The study will determine the impact that returning to normal physical activity
has on the participants brain's recovery from concussion. Fitbit GPS trackers will be assigned to concussed participants to measure how their Head Pulse recordings are affected by physical activity in the recovery process, which will then be compared to participants who remain sedentary through the recovery period.
Timepoint [1] 402785 0
These recordings will occur through the 30 day post concussion recovery period.

Eligibility
Key inclusion criteria
Male and female Australian footballers competing in the Adelaide Footy League.
Aged between 18 and 35 years
Control participants cannot have recorded a concussion for the previous 12 months.
All participants must have signed an informed consent form
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Must be competitors in the Adelaide Footy League

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a feasibility study to see how well we can record the head pulse from healthy participants and participants with concussion. If good quality data is obtained, the aim is to develop a model of head movement in the setting of concussion and recovery from concussion. Head pulse waveforms in each recording session will be normalized to the cardiac cycle to determine its characteristics in the space and frequency domains. Using this information , we will begin to develop an algorithm to categorize known, externally measured variables such as imaging characteristics or brain function characteristics with regard to how these variables align with head movement waveforms. We will compare waveforms obtained in participants with concussion to waveforms obtained in healthy controls.








Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2022
Actual
21/03/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
27/08/2022
Date of last data collection
Anticipated
30/09/2022
Actual
27/09/2022
Sample size
Target
80
Accrual to date
Final
80
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 310111 0
Commercial sector/Industry
Name [1] 310111 0
Sport and Real Knowledge P/L
Country [1] 310111 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Sport and Real Knowledge P/L
Address
506 Greenhill Road,
Hazelwood Park, SA, 5066
Country
Australia
Secondary sponsor category [1] 311176 0
None
Name [1] 311176 0
N/A
Address [1] 311176 0
N/A
Country [1] 311176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309799 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 309799 0
Ethics committee country [1] 309799 0
Australia
Date submitted for ethics approval [1] 309799 0
08/11/2021
Approval date [1] 309799 0
11/03/2022
Ethics approval number [1] 309799 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115430 0
Prof Professor Kevin Norton
Address 115430 0
Adelaide Fitness Solutions
3 Giles Avenue,
Glenelg South, SA, 5045
Country 115430 0
Australia
Phone 115430 0
+61 0417817026
Fax 115430 0
Email 115430 0
[email protected]
Contact person for public queries
Name 115431 0
Keith Thomas
Address 115431 0
Sport and Real Knowledge P/L
506 Greenhill Road,
Hazelwood Park, SA 5066
Country 115431 0
Australia
Phone 115431 0
+61 0417771588
Fax 115431 0
Email 115431 0
[email protected]
Contact person for scientific queries
Name 115432 0
Professor Kevin Norton
Address 115432 0
Adelaide Fitness Solutions
3 Giles Avenue,
Glenelg South, SA, 5045
Country 115432 0
Australia
Phone 115432 0
+61 0417817026
Fax 115432 0
Email 115432 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We consider that the secure, confidential treatment of all data collected during this trial is critically important to ensure that the information gathered cannot be used to assist in the diagnosis of concussion in participants. This must remain the exclusive domain of qualified medical staff.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14011Informed consent form  [email protected] The informed consent form is descriptive in nature... [More Details]
14015Study protocol  [email protected]
14016Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.