Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab) for Mild Traumatic Brain Injury: A Feasibility Trial

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSport Injury Prevention Research Centre

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Psychologically Informed CVPT (PIC) Rehab

    Behavioral

    Arm 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)

    Behavioral

    Cervical 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

34 Participants
are divided into 2 treatment groups
Group A: Cervicovestibular Rehabilitation (CVPT)Active comparator 1 intervention
Group B: Psychologically Informed CVPT (PIC Rehab)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Feasibility - Recruitment

Number of participants recruited

Time frame
From enrollment to the end of treatment at 8 weeks.
2

Feasibility - retention rate

Number of participants completing the trial divided by the total number of participants recruited

Time frame
From enrolment to the end of treatment at 8 weeks
3

Feasibility - Adverse events

Total number of adverse events

Time frame
From enrolment to the end of treatment at 8 weeks
4

Feasibility - barriers and facilitators

Barriers and facilitators to the protocol as described by the participants and the physiotherapists.

Time frame
From enrolment to the end of treatment at 8 weeks.

Secondary outcomes

1

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

Time frame
Initial and 8 weeks
2

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."

Time frame
From enrolment until treatment completion at 8 weeks
3

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.

Time frame
From enrolment to the end of treatment at 8 weeks.
4

Return to work

Return to pre-injury occupational activities with no new support, including occupational accommodations or modifications

Time frame
From enrolment to end of treatment at 8 weeks

Other outcomes

1

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.

Time frame
Initial and 8 weeks
2

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.

Time frame
Initial and 8 weeks following treatment initiation
3

Exploratory - Generalized Anxiety Disorder - 7

GAD-7 to measure self reported anxiety, scored 0-21 with greater score representing anxiety

Time frame
Initial and 8 weeks following treatment initiation
4

Exploratory - Personal Health Questionnaire-9

Personal Health Questionnaire - 9 to screen for depression, 0-27 with higher scores representing greater depression severity

Time frame
Initial and 8 weeks following treatment initiation

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

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