Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes

March 5, 2019 updated by: Kevin Shoemaker, Western University, Canada
The purpose of this investigation is to determine the effect of a weighted compression vest in addition to usual medical care and exercise rehabilitation on cardiovascular, neurocognitive, balance and anxiety measures in individuals medically diagnosed with, and being treated for, a mild traumatic brain injury.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Mild traumatic brain injury (mTBI), or concussion, induces significant impairment to a patient's mobility and tolerance for daily living activities with symptoms that include decreased balance, dizziness, confusion, headaches, visual and auditory sensitivities. If recognized promptly, many of these injuries respond well to immediate rest and standard rehabilitation strategies. However, approximately 10-30% of these patients will experience persistent symptoms beyond the ~2 week period of spontaneous healing. The persistent symptoms point to neural damage, or disrupted neural networks in the brain, but the actual mechanism or nature of neural damage remains to be elucidated. The brain's neural activity must be supported by rapid adjustments to, and optimal distribution of, blood flow. However, cerebrovascular control remains poorly studied in the context of persistent concussion symptoms, particularly the reactivity element of flow control such as how fast it recovers during drops in blood pressure such as when one stands up from the sitting posture. Cerebrovascular damage in mTBI appears to affect mostly the autoregulatory adjustments to changes in brain perfusion pressure (i.e., from lying down to standing up) (Len et al., 2013;Junger et al., 1997). The investigators will study the impact of mTBI in both acute and persistent stages on cerebrovascular adjustments to metabolic and pressure-dependent stimuli. Currently, decisions regarding rate and completeness of healing remain subjective which can lead to earlier-than-optimal return of the patient to inappropriate levels of activity, work or school. Improved and cost-effective markers of the rate and completeness of brain healing are needed that can be obtained in the clinic. One challenge might be the emphasis in previous investigations on searching for a single biomarker of damage in a highly integrated system. Rather, the investigators believe it may be more effective to employ a holistic perspective; focusing on a comprehensive neural outcome might provide enhanced insight into the severity of damage and rate or completion of recovery. Previously, several investigators established heart rate variability (HRV) as sensitive marker of abnormal brain function in TBI (traumatic brain injury) cases for both adults and children (Goldstein et al., 1998;Goldstein et al., 1996). Moreover, these studies imply that autonomic nervous system control of heart rate is disrupted in proportion to the degree of neurologic insult. Thus, heart rate power spectral analysis may prove to be a useful adjunct in determining severity of neurologic injury and prognosis for recovery. Despite many studies outlining the relationship between mTBI and HRV (Ryan et al., 2011;Goldstein et al., 1998;Goldstein et al., 1996;Papaioannou et al., 2008;La Fountaine et al., 2009) no follow-up research has been conducted to establish this method (which is cost-effective, non-invasive, comprehensive and easily-obtained) as a routine assessment of TBI severity, or rehabilitative efficacy. An additional neural network associated with cardiac function is the baroreflex and the sensitivity of this neural network (baroreflex sensitivity; BRS) can be studied with non-invasive measures of heart rate and blood pressure. In the past and currently our lab has used both methods of HRV and BRS safely and effectively (Zamir et al., 2013;Kiviniemi et al., 2010;Kiviniemi et al., 2011;Shoemaker et al., 2012). This current study will assess the feasibility and impact of routine measurements of cardiac dynamics as a sensitive marker of the severity and persistence of "overall" brain damage in mTBI patients. Based on more than 30 failed clinical trials, no single pharmacological agent can be prescribed to minimize TBI-induced brain damage, despite efficacy shown for several agents in rodent studies (see (Kabadi & Faden, 2014) for review). In contrast, non-pharmacological approaches in rodents, show that both pathophysiological changes and neurological impairment after experimental TBI can be attenuated by physical activity (Griesbach et al., 2004;Griesbach et al., 2009). Thus, there is value in considering application of "appropriate" exercise as soon as possible in mTBI patients, but not too soon because the value of exercise in rodent models were observed only when applied after the acute stage (Griesbach et al., 2007;Piao et al., 2013). Therefore, this study will also examine the impact of adding prescriptive exercise in addition to usual clinical care on the rate of concussion recovery. Enabling patients to receive the benefits of enhanced levels of physical activity during treatments for concussion may be limited by the concussion symptoms. Nonetheless, recent anecdotal evidence from our Parkwood group has illustrated the remarkable benefit to many patients with persistent symptoms provided by the wearing of a compression vest (HSREB #103325 and #104865). Briefly, the weighted compression vests (5% of the individual's body mass) are individualized and fitted to each subject to ensure its snug but does not impede one's respirations (similar to a bulletproof vest). The noted benefits of the compression vest include instant improvements to balance and gait, and reduced anxiety during stair climbing. Since this adaptive method of treatment appears to exert a powerful effect on enhancing patient's ability to perform exercise, and is consistent with the personalized medicine approach (like the exercise intervention), further investigation into the effect of the compression vest on concussion symptoms and rehabilitation is a viable area of research. To date the impact of compression vest interventions has yet to be examined in patients during the acute TBI phase or in younger individuals. Thus, the aim of the next phase of study is to establish whether interventions with a weighted compression vest can enhance exercise tolerance for patients in both acute and persistent phases of the TBI, with explorations into possible mechanistic links to cerebrovascular, cardiovascular and neural outcomes. If so, then new evidence supporting the use of compression vests could change clinical practice and, importantly, improve long-term health outcomes for many patients. In review, the purpose of this investigation is to determine the efficacy of novel methods of mild traumatic brain injury rehabilitation in addition to usual concussion rehabilitation programs. Concussed participants will complete a longitudinal study in which they will be randomly allocated to one of three rehabilitation groups: 1) usual care 2) usual care + exercise 3) usual care + exercise + compression vest. The efficacy of each rehabilitation group will be primarily quantified via changes in routine cardiac dynamic measurements (HRV, BRS, changes in blood flow with changes in posture).

Study Type

Interventional

Enrollment (Actual)

153

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 3K7
        • Fowler Kennedy Sports Medicine Clinic
      • London, Ontario, Canada, N6A 3K7
        • Neurovascular Research Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 38 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • concussed: medically diagnosed with, and being treated for a concussion for no longer than 1 year
  • healthy volunteer: no previous medical diagnosis of a concussion

Exclusion Criteria:

  • bone or muscle problems that could impact balance or how well you walk
  • diagnosis of pre-existing heart disease
  • medications that affect heart or blood vessel control
  • pre-existing brain disorders such as Parkinson's, Multiple Sclerosis, Raynaud's, Multiple System Atrophy, metabolic disorders such as diabetes, a history of significant neck injury, or focal neurologic deficit
  • primary or metastatic bone tumour
  • severe osteoporosis
  • if you are, or think you might be, pregnant or breastfeeding
  • if you are not able to be understand English

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual care + exercise
Other: exercise
exercise
No Intervention: No care, no exercise
Experimental: Usual care + exercise + compression vest
Usual care + exercise + London Health Sciences Centre - Compression Vest
Other: exercise
exercise
Device: London Health Sciences Centre - Compression Vest
London Health Sciences Centre - Compression Vest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in symptom profile
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Timeline to asymptomatic and clinical discharge
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Change in exercise tolerance
Time Frame: baseline, four-weeks post-baseline, six-week post-baseline
Duration and wattage achieved at symptom exacerbation
baseline, four-weeks post-baseline, six-week post-baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Generalized Anxiety Disorder 7-item (GAD-7) scale
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Balance
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Change in Stability Index, quantified via BioDex Technology
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Transcranial Doppler Ultrasound - Cerebrovascular Function
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Change in middle cerebral artery blood velocity - cm/s
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Heart Rate Variability
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Measure of autonomic function - quantified via R-R interval duration (seconds)
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Baroreflex Sensitivity
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Measure of autonomic function - quantified via changes in blood pressure for a given heart rate
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Cognitive Function
Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline
Cogingram - assessment of psychomotor function, attention, learning and working memory
baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western University, Canada

Collaborators

Lawson Health Research Institute

Investigators

  • Principal Investigator: Kevin Shoemaker, PhD, Western University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 4, 2019

Study Completion (Actual)

March 4, 2019

Study Registration Dates

First Submitted

February 5, 2015

First Submitted That Met QC Criteria

February 11, 2015

First Posted (Estimate)

February 12, 2015

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CON001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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