About this trial
Mild traumatic brain injuries ("mTBIs") affect over 480,000 Canadians each year. While many individuals recover in the initial 4 weeks following mTBI, in up to 30% of individuals symptoms and functional impairments often persist leading to significant disability, decreased quality of life and participation in education, physical and occupational related activities. An assessment that evaluates multiple systems is recommended for individuals with mTBI, often involving multiple health care professionals to assess different areas of function (e.g. oculomotor, vestibular, balance, mood, cognition, etc). Current evidence supports the use of cervicovestibular rehabilitation (CVPT) (which includes physiotherapy techniques aimed at treating the neck, balance, visual and other sensory systems) and symptom-tolerated exercise. Evidence suggests that collaborative care, cognitive behavioural therapy (CBT) may be of benefit. However, the added value of CVPT and CBT in combination co-designed by patients and community partners has not yet been evaluated in mTBI. In other pain and dizziness conditions, the addition of CBT to physical/vestibular rehabilitation yielded improved outcomes. Here we take a transdisciplinary team-based approach to evaluate an integrated combination of CVPT and CBT.
This study will recruit a total of 34 people ages 18-70 years old who have ongoing symptoms following an mTBI for more than two weeks. The first 17 patients will receive CVPT along and the second 17 patients will receive psychologically informed CVPT ("PIC" Rehab). This study will help determine if combined therapy has an additive effect on helping patients recovery from mTBI.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Reporting dizziness, neck pain and/or headaches for at least 14 days following mild traumatic brain injury/concussion who are referred for cervicovestibular physiotherapy with one or more impairments related to the vestibular, oculomotor, sensorimotor, cervical spine, neuromuscular control.
Disqualifiers
Patients who have previously undergone a session of cervicovestibular physiotherapy will be excluded
Trial design
Parallel
Treatments tested in this trial
Psychologically Informed CVPT (PIC) Rehab
BehavioralArm Description: Cognitive behavioural therapy (CBT) is a form of treatment that uses multiple non-pharmacological strategies including education, behavioural and cognitive strategies to assist with decreasing symptoms. The experimental PIC Rehab arm will include principles of CBT in combination with the CVPT.
Cervicovestibular Rehabilitation (CVPT)
BehavioralCervical and vestibular rehabilitation including individually targeted impairments based treatment techniques such as neuromuscular control, joint position sense, manual therapy, adaptation, habituation, canalith repositioning maneouvers, standing balance exercises, dynamic balance exercises, sport and work specific exercises.
Treatment groups
Trial outcomes
Primary outcomes
Feasibility - Recruitment
Number of participants recruited
Feasibility - retention rate
Number of participants completing the trial divided by the total number of participants recruited
Feasibility - Adverse events
Total number of adverse events
Feasibility - barriers and facilitators
Barriers and facilitators to the protocol as described by the participants and the physiotherapists.
Secondary outcomes
Symptom Severity Score (SSS)
As measured on the Post Concussion Symptom Scale from the Sport Concussion Assessment tool, /132 where 0 represents no symptoms and 132 the most severe symptoms
Date of Medical Clearance to Return to Sport
Defined as per the Amsterdam International Consensus statement (Patricios, Schneider et al 2023, page 702): "Completion of the RTS strategy with no symptoms and no clinical findings associated with the current concussion at rest and with maximal physical exertion."
Date of Return to full learn
Defined as per the Amsterdam international consensus on concussion in sport (Patricios, Schneider et al 2023 page 702): Return to pre-injury learning activities with no new academic support, including school accommodations or learning adjustments.
Return to work
Return to pre-injury occupational activities with no new support, including occupational accommodations or modifications
Other outcomes
Exploratory - Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI)
Validated measures of fear avoidance in TBI, 0-48 with higher score representing greater fear avoidance.
Exploratory - World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12 item
WHO measure of self reported disability, scored 0-48 with higher score representing greater disability.
Exploratory - Generalized Anxiety Disorder - 7
GAD-7 to measure self reported anxiety, scored 0-21 with greater score representing anxiety
Exploratory - Personal Health Questionnaire-9
Personal Health Questionnaire - 9 to screen for depression, 0-27 with higher scores representing greater depression severity
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sport Injury Prevention Research Centre
Lead sponsor
University of Calgary
Collaborator
Brain Injury Canada
Collaborator
This trial is not recruiting at the moment. You can still explore other options: