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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02362347
• Date of registration: 05/02/2015
• Prospective Registration: No
• Primary sponsor: Western University, Canada
• Public title: Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
• Scientific title: Investigating Novel Treatments for Concussion: Impact of Compression Vest on Rehabilitation Outcomes
• Date of first enrolment: February 2015
• Target sample size: 153
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02362347
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Kevin Shoemaker, PhD
• Affiliation: Western University

Key inclusion & exclusion criteria

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



Age minimum: 12 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Post-Concussion Syndrome

Brain Concussion

Intervention(s)

Device: London Health Sciences Centre - Compression Vest

Other: exercise

Primary Outcome(s)

Change in symptom profile [Time Frame: 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]

Secondary Outcome(s)

Baroreflex Sensitivity [Time Frame: 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]

Cognitive Function [Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline]

Anxiety [Time Frame: 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]

Heart Rate Variability [Time Frame: baseline, two-weeks, three-weeks, four-weeks, 5-weeks and 6-weeks post-baseline]

Secondary ID(s)

CON001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Lawson Health Research Institute