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?

This trial explores new methods to aid recovery from mild traumatic brain injuries (mTBIs), such as concussions, by combining two types of therapy. One group will receive cervicovestibular rehabilitation (CVPT), which includes exercises and treatments for the neck and balance systems. The other group will receive CVPT combined with cognitive behavioral therapy (CBT), which addresses mood and cognitive issues. This combined approach is known as Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab). The goal is to determine if adding CBT to physical therapy enhances recovery. Individuals experiencing dizziness, neck pain, or headaches 14 days after a concussion may be suitable for this trial, provided they have not previously undergone this therapy. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to be among the first to receive this innovative therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cervicovestibular rehabilitation (CVPT), which includes exercises for the neck, balance, and vision, is supported by evidence and is safe and effective for concussion recovery. This treatment enhances the coordination between the brain and body, particularly for balance and coordination.

Adding cognitive behavioral therapy (CBT), a non-drug method using education and strategies to reduce symptoms, has shown benefits in similar conditions involving pain and dizziness. CBT is safe and helps individuals manage symptoms by changing thoughts and behaviors.

Although this trial is in its early phase, with detailed safety data still being collected, both CVPT and CBT have been used separately in other treatments and are generally well-tolerated. This suggests that combining them in the trial should be safe for participants. Researchers will closely monitor participants to ensure their safety throughout the study.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab) because it combines traditional cervicovestibular therapy with cognitive behavioral therapy (CBT), a fresh twist on concussion care. This approach not only tackles the physical aspects of recovery, like balance and coordination, but also addresses the psychological symptoms, which are often overlooked in standard treatments. By integrating CBT, PIC Rehab offers a dual-action strategy that might enhance recovery rates and improve overall well-being for concussion patients.

What evidence suggests that this trial's treatments could be effective for mTBI?

Research has shown that cervicovestibular rehabilitation (CVPT), one of the treatment arms in this trial, can aid people with mild traumatic brain injuries (mTBI) by targeting the neck and balance systems, potentially reducing symptoms like dizziness and neck pain. Another treatment arm, Psychologically Informed Cervicovestibular Rehabilitation (PIC Rehab), combines CVPT with cognitive behavioral therapy (CBT). Studies suggest that adding CBT to physical rehabilitation can enhance outcomes for conditions involving dizziness and pain. This combination uses CBT techniques to manage symptoms alongside physical exercises. Evidence from other conditions indicates that this approach can boost recovery by addressing both physical and mental aspects. Initial findings, although not specific to mTBI, support the potential benefits of combining these therapies.12678

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+

Citations

Psychologically Informed Cervicovestibular Rehabilitation ...

Exploratory outcomes will include the following: Fear Avoidance Behaviour after Traumatic Brain Injury Questionnaire (FAB-TBI); World Health ...

Effectiveness of Vestibular Rehabilitation after Concussion

VR seems useful to reduce symptoms in patients with concussion; however, a huge heterogeneity of the studies and of the outcomes used were found.

Psychologically Informed Rehabilitation for Concussion ...

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 ...

Cervicovestibular rehabilitation in adult with mild traumatic ...

The cervicovestibular rehabilitation program will include education, cervical spine manual therapy and exercises, vestibular rehabilitation and home exercises.

Cervicovestibular rehabilitation in adult with mild traumatic ...

Controlled trials are needed to determine the best rehabilitation approach for mTBI with persistent symptoms such as neck pain, headache and dizziness.

A Systematic Review of Treatments of Post-Concussion ... - PMC

Cognitive training, psycho-education, cognitive behavioral therapy, and graded return to physical activity demonstrated some effectiveness on persistent PCS.

Concussion rehabilitation through a cervical spine ...

Many studies of varying levels of evidence support that physical rehabilitation interventions for cervical spine dysfunction may improve outcomes.

Effectiveness of a Customized Rehabilitation Program for...

Main Measures: The primary outcome measure was the Rivermead Post-Concussion Questionnaire (RPQ-3 and RPQ-13). Secondary outcome measures ...