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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]

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)

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Alternative and Complementary Medicine

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]

Treatment: Other

Intervention code [2]

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]

Change in post-concussion symptoms

Timepoint [1]

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]

Recruitment rate

Timepoint [2]

End of recruitment phase.

Primary outcome [3]

Accrual rate

Timepoint [3]

End of recruitment phase.

Secondary outcome [1]

Change in health status

Timepoint [1]

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]

Change in anxiety levels

Timepoint [2]

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]

Change in dizziness symptoms

Timepoint [3]

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]

Change in neck function

Timepoint [4]

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]

Change in neck pain

Timepoint [5]

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]

Change in sleep quality

Timepoint [6]

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]

Change in quality of life

Timepoint [7]

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]

Change in cognitive interference

Timepoint [8]

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]

Change in working memory

Timepoint [9]

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]

Change in concussion symptoms

Timepoint [10]

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]

Change in static balance status

Timepoint [11]

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]

Change in exercise tolerance

Timepoint [12]

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]

Retention rate

Timepoint [13]

End of assessment phase.

Secondary outcome [14]

Attrition rate

Timepoint [14]

End of assessment phase.

Secondary outcome [15]

Adverse events

Timepoint [15]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Australian Chiropractic Education and Research Foundation

Address [1]

Country [1]

Australia

Funding source category [2]

Other

Name [2]

Philanthropic donation

Address [2]

Country [2]

Australia

Primary sponsor type

University

Name

Macquarie University

Address

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Macquarie University Human Research Ethics Committee Medical Sciences

Ethics committee address [1]

https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/09/2023

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

Post-concussion syndrome (PCS) impacts the injured and their families. Symptoms can occur at the time of injury or may be delayed and develop some time after the initial injury. Standard care for people with PCS includes sub-threshold exercise. Evidence also exists for the use of vestibular rehabilitation and manual therapy (mobilisation and manipulation of the neck and spine) in the management of PCS.  
As active management is becoming the preferred approach for patients with PCS, the aim of this study is to assess the feasibility of administering two combinations of active interventions to people with PCS: vestibular rehabilitation with exercise and manual therapy with exercise. 
The study will recruit 30 participants between the ages of 18 and 50 with sports-related PCS. Participants will be randomly allocated to one of three groups: exercise only; exercise plus vestibular rehabilitation; or exercise plus manual therapy. Participants will receive 8 intervention sessions over a 4-week period at the rate of 2 sessions per week.  
Outcome measurements will be administered at baseline,4, 8 and 12 weeks post-intervention.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Roger Engel

Address

Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2019

Country

Australia

Phone

+61 438726061

Fax

[email protected]

Contact person for public queries

Name

Roger Engel

Address

Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2109

Country

Australia

Phone

+61 438726061

Fax

[email protected]

Contact person for scientific queries

Name

Roger Engel

Address

Department of Chiropractic, Faculty of Medicine Health and Human Sciences, Macquarie University 75 Talavera Road, North Ryde NSW 2109

Country

Australia

Phone

+61 438726061

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
23987	Study 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.

Trial Review

Documents added manually

Documents added automatically