Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Fowler Kennedy Sports Medicine Clinic
-
London, Ontario, Canada, N6A 3K7
- Neurovascular Research Laboratory
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Active Comparator: Usual care + exercise
|
exercise
|
|
No Intervention: No care, no exercise
|
|
|
Experimental: Usual care + exercise + compression vest
Usual care + exercise + London Health Sciences Centre - Compression Vest
|
exercise
London Health Sciences Centre - Compression Vest
|
What is the study measuring?
Primary Outcome Measures
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
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
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Kevin Shoemaker, PhD, Western University
Publications and helpful links
General Publications
- Griesbach GS, Gomez-Pinilla F, Hovda DA. Time window for voluntary exercise-induced increases in hippocampal neuroplasticity molecules after traumatic brain injury is severity dependent. J Neurotrauma. 2007 Jul;24(7):1161-71. doi: 10.1089/neu.2006.0255.
- Griesbach GS, Hovda DA, Gomez-Pinilla F. Exercise-induced improvement in cognitive performance after traumatic brain injury in rats is dependent on BDNF activation. Brain Res. 2009 Sep 8;1288:105-15. doi: 10.1016/j.brainres.2009.06.045. Epub 2009 Jun 23.
- Piao CS, Stoica BA, Wu J, Sabirzhanov B, Zhao Z, Cabatbat R, Loane DJ, Faden AI. Late exercise reduces neuroinflammation and cognitive dysfunction after traumatic brain injury. Neurobiol Dis. 2013 Jun;54:252-63. doi: 10.1016/j.nbd.2012.12.017. Epub 2013 Jan 8.
- Goldstein B, Kempski MH, DeKing D, Cox C, DeLong DJ, Kelly MM, Woolf PD. Autonomic control of heart rate after brain injury in children. Crit Care Med. 1996 Feb;24(2):234-40. doi: 10.1097/00003246-199602000-00009.
- Goldstein B, Toweill D, Lai S, Sonnenthal K, Kimberly B. Uncoupling of the autonomic and cardiovascular systems in acute brain injury. Am J Physiol. 1998 Oct;275(4):R1287-92. doi: 10.1152/ajpregu.1998.275.4.R1287.
- Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
- Junger EC, Newell DW, Grant GA, Avellino AM, Ghatan S, Douville CM, Lam AM, Aaslid R, Winn HR. Cerebral autoregulation following minor head injury. J Neurosurg. 1997 Mar;86(3):425-32. doi: 10.3171/jns.1997.86.3.0425.
- Kabadi SV, Faden AI. Neuroprotective strategies for traumatic brain injury: improving clinical translation. Int J Mol Sci. 2014 Jan 17;15(1):1216-36. doi: 10.3390/ijms15011216.
- Kiviniemi AM, Frances MF, Tiinanen S, Craen R, Rachinsky M, Petrella RJ, Seppanen T, Huikuri HV, Tulppo MP, Shoemaker JK. alpha-Adrenergic effects on low-frequency oscillations in blood pressure and R-R intervals during sympathetic activation. Exp Physiol. 2011 Aug;96(8):718-35. doi: 10.1113/expphysiol.2011.058768. Epub 2011 May 20.
- Kiviniemi AM, Tiinanen S, Hautala AJ, Seppanen T, Makikallio TH, Huikuri HV, Tulppo MP. Frequency of slow oscillations in arterial pressure and R-R intervals during muscle metaboreflex activation. Auton Neurosci. 2010 Jan 15;152(1-2):88-95. doi: 10.1016/j.autneu.2009.08.020. Epub 2009 Sep 19.
- La Fountaine MF, Heffernan KS, Gossett JD, Bauman WA, De Meersman RE. Transient suppression of heart rate complexity in concussed athletes. Auton Neurosci. 2009 Jun 15;148(1-2):101-3. doi: 10.1016/j.autneu.2009.03.001. Epub 2009 Mar 21.
- Len TK, Neary JP, Asmundson GJ, Candow DG, Goodman DG, Bjornson B, Bhambhani YN. Serial monitoring of CO2 reactivity following sport concussion using hypocapnia and hypercapnia. Brain Inj. 2013;27(3):346-53. doi: 10.3109/02699052.2012.743185.
- Papaioannou V, Giannakou M, Maglaveras N, Sofianos E, Giala M. Investigation of heart rate and blood pressure variability, baroreflex sensitivity, and approximate entropy in acute brain injury patients. J Crit Care. 2008 Sep;23(3):380-6. doi: 10.1016/j.jcrc.2007.04.006. Epub 2007 Dec 11.
- Ryan ML, Ogilvie MP, Pereira BM, Gomez-Rodriguez JC, Manning RJ, Vargas PA, Duncan RC, Proctor KG. Heart rate variability is an independent predictor of morbidity and mortality in hemodynamically stable trauma patients. J Trauma. 2011 Jun;70(6):1371-80. doi: 10.1097/TA.0b013e31821858e6.
- Shoemaker JK, Usselman CW, Rothwell A, Wong SW. Altered cortical activation patterns associated with baroreflex unloading following 24 h of physical deconditioning. Exp Physiol. 2012 Dec;97(12):1249-62. doi: 10.1113/expphysiol.2012.065557. Epub 2012 May 21.
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimate)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- CON001
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