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Trial registered on ANZCTR


Registration number
ACTRN12624000944538p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility trial investigating manual therapy and vestibular rehabilitation for mild traumatic brain injury
Scientific title
A 3-arm parallel feasibility trial investigating manual therapy and vestibular rehabilitation for mild traumatic brain injury in patients with post-concussion syndrome
Secondary ID [1] 312515 0
Nil
Universal Trial Number (UTN)
Trial acronym
The MATVER trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild traumatic brain injury (post-concussion syndrome) 334383 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331023 331023 0 0
Other physical medicine / rehabilitation
Alternative and Complementary Medicine 331024 331024 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Manual therapy: 30-minute treatment sessions; Grades 2, 3 & 4 joint mobilisation and Grade 5 joint manipulation to the cervical spine administered face-to-face by chiropractors/osteopaths with a minimum of 5 years' experience in the field; 8 sessions over 4 weeks @ 2 x week; location Macquarie University chiropractic clinic; all clinical data recorded in treatment log.

Arm 2: Vestibular Rehabilitation: 30-minute treatment sessions; low to moderate cervico-vestibular specific rehabilitation exercise administered face-to-face by a health practitioner with a minimum of 5 years' experience in the field and assessed using the Borg RPE scale; 8 sessions over 4 weeks @ 2 x week; location Macquarie University chiropractic clinic; all clinical data recorded in treatment log.



Intervention code [1] 329036 0
Treatment: Other
Intervention code [2] 329083 0
Rehabilitation
Comparator / control treatment
Comparator: Cardiovascular exercise: 30-minute exercise sessions; sub-threshold walking exercise (low to moderate intensity) on a treadmill supervised face-to-face by an exercise physiologist with a minimum of 5 years' experience in the field and assessed using the Borg RPE scale as a measure of intensity; 8 sessions over 4 weeks @ 2 x week; location Macquarie University chiropractic clinic; session attendance recorded in treatment log.

Control group
Active

Outcomes
Primary outcome [1] 338788 0
Change in post-concussion symptoms
Timepoint [1] 338788 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Primary outcome [2] 338867 0
Recruitment rate
Timepoint [2] 338867 0
End of recruitment phase.
Primary outcome [3] 338868 0
Accrual rate
Timepoint [3] 338868 0
End of recruitment phase.
Secondary outcome [1] 437458 0
Change in health status
Timepoint [1] 437458 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [2] 437459 0
Change in anxiety levels
Timepoint [2] 437459 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [3] 437461 0
Change in dizziness symptoms
Timepoint [3] 437461 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [4] 437462 0
Change in neck function
Timepoint [4] 437462 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [5] 437463 0
Change in neck pain
Timepoint [5] 437463 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [6] 437464 0
Change in sleep quality
Timepoint [6] 437464 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [7] 437465 0
Change in quality of life
Timepoint [7] 437465 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [8] 437466 0
Change in cognitive interference
Timepoint [8] 437466 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [9] 437467 0
Change in working memory
Timepoint [9] 437467 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [10] 437468 0
Change in concussion symptoms
Timepoint [10] 437468 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [11] 437469 0
Change in static balance status
Timepoint [11] 437469 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [12] 437470 0
Change in exercise tolerance
Timepoint [12] 437470 0
Baseline, 4 weeks post-commencement of intervention (4 weeks), 4 weeks post-completion of intervention (8 weeks), and 8 weeks post-completion of intervention (12 weeks).
Secondary outcome [13] 437722 0
Retention rate
Timepoint [13] 437722 0
End of assessment phase.
Secondary outcome [14] 437723 0
Attrition rate
Timepoint [14] 437723 0
End of assessment phase.
Secondary outcome [15] 437724 0
Adverse events
Timepoint [15] 437724 0
End of intervention phase.

Eligibility
Key inclusion criteria
Sport-related mild traumatic brain injury with persistent vestibular and neck symptomatology >4 and <26 weeks (post-concussion syndrome)
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of previous mTBI within 12 months of current injury
• History of moderate/severe TBI (self-reported loss of consciousness >30 minutes and/or post-traumatic amnesia >24 hours and/or Glasgow Coma Scale score <13 after 30 minutes post-injury (from medical chart))
• History of recent skull or cervical spine fracture
• History of seizures, fluid build-up in the brain (hydrocephalus), brain-related infections such as encephalitis or meningitis or brain-related blood vessel damage
• History of cranial or cervical surgery
• Osteoporosis (bone scan/DEXA)
• Fail the Canadian C-Spine Rule (decision-making tool used to determine when Cervical radiography should be utilised following trauma: fail = need for Cervical radiography).
• Currently pregnant (self-reported)
• Typical contra-indications to MT
• Not able to tolerate exercise protocol (as assessed by screening exercise questions)
• Unable to walk on a flat surface unaided for 1 minute (self-reported)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The allocation sequence will uploaded to REDCap which has a built-in randomisation module whereby the externally generated allocation sequence is concealed from all other trial staff.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation to the three groups will be on a 1:1:1 basis, with random blocks of 6 participants to reduce the predictability of the allocation sequence. The allocation sequence will be generated by a statistician using an online random sequence generator (Sealed Envelope Ltd, London, United Kingdom).
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
Statistical methods / analysis
Participant demographics and baseline characteristics will be analysed using descriptive statistics.
All primary and secondary outcome measures are continuous and will be analysed using mixed-effects models for repeated measures (MMRM).
Feasibility outcomes include recruitment, accrual, retention, attrition and adverse event rates.
Recruitment rate = number of participants enrolled divided by number of assessed (or eligible) participants.
Accrual rate = number of participants enrolled divided by number of months of recruitment.
Retention rate = number of enrolled participants completing 4/8/12-week measures divided by number of enrolled participants.
Attrition rate = number of enrolled participants not completing 4/8/12-week measures divided by number of enrolled participants.
Adverse events = number of adverse events over number of intervention sessions.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/09/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316939 0
Charities/Societies/Foundations
Name [1] 316939 0
Australian Chiropractic Education and Research Foundation
Country [1] 316939 0
Australia
Funding source category [2] 316941 0
Other
Name [2] 316941 0
Philanthropic donation
Country [2] 316941 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 319185 0
None
Name [1] 319185 0
Address [1] 319185 0
Country [1] 319185 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315691 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 315691 0
Ethics committee country [1] 315691 0
Australia
Date submitted for ethics approval [1] 315691 0
01/09/2023
Approval date [1] 315691 0
Ethics approval number [1] 315691 0

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

Contacts
Principal investigator
Name 135518 0
Dr Roger Engel
Address 135518 0
Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2019
Country 135518 0
Australia
Phone 135518 0
+61 438726061
Fax 135518 0
Email 135518 0
[email protected]
Contact person for public queries
Name 135519 0
Roger Engel
Address 135519 0
Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2109
Country 135519 0
Australia
Phone 135519 0
+61 438726061
Fax 135519 0
Email 135519 0
[email protected]
Contact person for scientific queries
Name 135520 0
Roger Engel
Address 135520 0
Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2109
Country 135520 0
Australia
Phone 135520 0
+61 438726061
Fax 135520 0
Email 135520 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
Given this is a feasibility trial, there are no plans to make the participant level-data and statistical code publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23987Study protocol    388115-(Uploaded-11-07-2024-18-07-04)-Protocol Version 3 23 June 2024.docx



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.