Psychologically Informed Rehabilitation for Concussion

(PIC Rehab Trial)

KS
Overseen ByKathryn Schneider, PT, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Sport Injury Prevention Research Centre
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

KS

Kathryn Schneider, PT PhD

Principal Investigator

University of Calgary

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-70 in Canada who have had symptoms like dizziness, neck pain, or headaches for over two weeks after a mild traumatic brain injury or concussion. They should need cervicovestibular physiotherapy and have related impairments.

Inclusion Criteria

I've had dizziness, neck pain, or headaches for over 2 weeks after a mild brain injury.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either CVPT or PIC Rehab once weekly for 8 weeks

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab)

Trial Overview

The study compares traditional Cervicovestibular Rehabilitation (CVPT) with Psychologically Informed CVPT (PIC Rehab), which combines CVPT with cognitive behavioural therapy techniques. It aims to see if the combined approach better aids recovery from mTBI.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Psychologically Informed CVPT (PIC Rehab)Experimental Treatment2 Interventions
Group II: Cervicovestibular Rehabilitation (CVPT)Active Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sport Injury Prevention Research Centre

Lead Sponsor

Trials
9
Recruited
4,400+

University of Calgary

Collaborator

Trials
827
Recruited
902,000+

Brain Canada

Collaborator

Trials
22
Recruited
6,100+