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

NCT07402733 | Not Yet Recruiting Phase 1

• 1 other identifier: PIC Rehab
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Traumatic Brain Injury, Concussion

Keywords

rehabilitation; cervical spine; vestibular; cognitive behavioural therapy; treatment

Outcome Measures

Primary Outcomes (5)

• Feasibility - Recruitment

  Number of participants recruited

  From enrollment to the end of treatment at 8 weeks.

• Feasibility - retention rate

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

  From enrolment to the end of treatment at 8 weeks

• Feasibility - Adverse events

  Total number of adverse events

  From enrolment to the end of treatment at 8 weeks

• Feasibility - barriers and facilitators

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

  From enrolment to the end of treatment at 8 weeks.

• Feasibility - Adherence to protocol by therapist

  Adherence will be measured through voice recording review of the therapist treatment prescription in comparison to the specific group treatment protocol. The choice of treatment by the therapist will be matched to the treatment choice on the treatment protocol and rated as "yes" adheres or "no" does not adhere for each component of treatment at each recorded session. The proportion of components adhered to will be summarized.

  From enrolment to the end of treatment at 8 weeks.

Secondary Outcomes (4)

• Symptom Severity Score (SSS)

  Initial and 8 weeks

• Date of Medical Clearance to Return to Sport

  From enrolment until treatment completion at 8 weeks

• Date of Return to full learn

  From enrolment to the end of treatment at 8 weeks.

• Return to work

  From enrolment to end of treatment at 8 weeks

Other Outcomes (28)

• Exploratory - Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI)

  Initial and 8 weeks

• Exploratory - World Health Organization Disability Assessment Schedule (WHODAS) 2.0 12 item

  Initial and 8 weeks following treatment initiation

• Exploratory - Generalized Anxiety Disorder - 7

  Initial and 8 weeks following treatment initiation

Study Arms (2)

Cervicovestibular Rehabilitation (CVPT)

ACTIVE COMPARATOR

CVPT includes treatments targeting neuromuscular and sensorimotor control in combination with manual therapy and soft tissue techniques as indicated.5 16 Specific rehabilitation exercises are gradually progressed, performed in combination with symptom-tolerated aerobic exercise, and eventually evolve to task, context, and/or sport specific exercises.16 From a mechanistic standpoint, the goal of this treatment is to facilitate sensorimotor integration (i.e. integration of visual, vestibular, proprioceptive input and resultant motor output) and either reweigh central balancing of stimuli to optimize function of these systems or upregulate the use of alternate systems in the event that one of the sensory systems is not optimally operating.5 17 Recent international consensus recommendations and clinical practice guidelines recommend CVPT as a treatment that has some of the strongest evidence to date to facilitate recovery.14 18

Behavioral: Cervicovestibular Rehabilitation (CVPT)

Psychologically Informed CVPT (PIC Rehab)

EXPERIMENTAL

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.

Behavioral: Psychologically Informed CVPT (PIC) Rehab; Behavioral: Cervicovestibular Rehabilitation (CVPT)

Interventions

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.

Psychologically Informed CVPT (PIC Rehab)

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.

Cervicovestibular Rehabilitation (CVPT); Psychologically Informed CVPT (PIC Rehab)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who have previously undergone a session of cervicovestibular physiotherapy will be excluded

Sponsors & Collaborators

• Brain Injury Canada: collaborator
• Sport Injury Prevention Research Centre: lead
• University of Calgary: collaborator

Study Sites (1)

Evidence Sport and Spinal Therapy North

Calgary, Alberta, T3B6B1, Canada

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kathryn Schneider, PT PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Schneider, PT, PhD

CONTACT

+1-403-210-8951; kjschnei@ucalgary.ca

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the hypothesis of the study and to the opposite treatment group to which they are assigned. Thus, two separate consent forms will be used in the study - one for each type of treatment received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a pilot feasibility study where the initial group will receive standard cervicovestibular rehabilitation. Subsequently, the same therapists will be trained in psychologically informed cervicovestibular rehabilitation and the patients recruited after this training will be in the psychologically informed cervicovestibular rehabilitation group.

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 11, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CA (1)