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

Condition(s) studied

Investigational drug(s) / intervention(s)

Psychologically Informed CVPT (PIC) Rehab: 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): 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.

Study 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.

Eligibility

Primary outcome measure(s)

• Feasibility - Recruitment — From enrollment to the end of treatment at 8 weeks.
  Number of participants recruited
• Feasibility - retention rate — From enrolment to the end of treatment at 8 weeks
  Number of participants completing the trial divided by the total number of participants recruited
• Feasibility - Adverse events — From enrolment to the end of treatment at 8 weeks
  Total number of adverse events
• Feasibility - barriers and facilitators — From enrolment to the end of treatment at 8 weeks.
  Barriers and facilitators to the protocol as described by the participants and the physiotherapists.
• Feasibility - Adherence to protocol by therapist — From enrolment to the end of treatment at 8 weeks.
  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.

Trial sites (1)

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