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A feasibility trial investigating manual therapy and vestibular rehabilitation for mild traumatic brain injury

A 3-arm parallel feasibility trial investigating manual therapy and vestibular rehabilitation for mild traumatic brain injury in patients with post-concussion syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000944538
Acronym
The MATVER trial
Enrollment
30
Registered
2024-08-05
Start date
2024-09-02
Completion date
2025-06-30
Last updated
2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 rehabil

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.

Sponsors

Macquarie University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

Sport-related mild traumatic brain injury with persistent vestibular and neck symptomatology >4 and <26 weeks (post-concussion syndrome)

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026