Clinical trial NCT02084329: Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest
Official title: Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: Physiotherapy
Physical therapy
neurotrauma rehabilitation
Rehabilitation
Balance
Balance Confidence
concussion
Post-Concussion
Mild Traumatic Brain Injury
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: After a mild traumatic brain injury (mTBI) people often report balance problems. At Parkwood hospital we have noticed that balance is improved when patients with mTBI wear a weighted compression vest. This follow up pilot study looks at the immediate effects of weighted compression vests on participants with altered balance after mTBI. Participants will be recruited from the Ministry of Health Outpatient Acquired Brain Injury (ABI) Program wait list. Then each participant will perform a series of balance and walking tests under 2 conditions : 1) wearing a weighted compression vest , 2) not wearing a weighted compression vest. It will be randomized whether participants wear the vest on the first or second testing day. Participants will also be asked how confident they are about their balance and how anxious they felt performing the assessments after each testing session. We hypothesize that the weighted compression vest will improve fatigue and anxiety immediately and 24 hours after performing a complex task, and will improve static and dynamic balance, gait variability, and walking speed in patients with mTBI, during the tasks.


Eligibility criteria: Inclusion Criteria:

* Diagnosed concussion. Symptoms persistent for more than 3 months. Self-reported balance deficits. Participants have been referred by a physician to the Outpatient ABI team at Parkwood. Participants have been screened by the ABI team and are currently awaiting treatment. No other diagnosed orthopedic injuries or significant health conditions. Able to follow instructions

Exclusion Criteria:

* Other pre-existing vestibular problems. Other diagnosed orthopedic injuries or significant health conditions that impair balance or mobility.

Primary outcomes:
measure: Modified Clinical Test of Sensory Interaction on Balance(mCTSIB)
timeFrame: The mCTSIB will take less than 10 minutes to administer. It will be administered twice: once on intervention day 1, and once on intervention day 2 (1 week apart). The outcome measures will be administered in the same sequence each intervention day.
measure: The Functional Gait Assessment (FGA)
timeFrame: The FGA takes less then 10 minutes to administer. It will be administered twice: once on intervention day one, and once on intervention day two (one week later).
measure: The Rivermead Post-Concussion Questionnaire
timeFrame: This outcome measure will be completed by participants prior to testing on intervention day 1 and 2
measure: The 10 Metre walk test
timeFrame: The test will take less than 10 minutes to administer. It will be administered twice: once on intervention day 1, and once on intervention day 2 (1 week apart). The outcome measures will be administered in the same sequence each intervention day.
measure: Walking While Talking on a Gait Rite Mat
timeFrame: This will take less than 10 minutes to administer. It will be administered twice: once on intervention day 1, and once on intervention day 2 (1 week apart). The outcome measures will be administered in the same sequence each intervention day.
Secondary outcomes:
measure: Anxiety Numerical Rating Scale
timeFrame: Participants will be asked to rate their anxiety before, immediately after, and 24 hours after testing on days one and two.
measure: Fatigue Numerical Rating Scale
timeFrame: Participants will be asked to rate their fatigue before, immediately after, and 24 hours after testing on days one and two.
Other outcomes:
Locations:
city: London
country: Canada
facility: Parkwood Hospital- St. Joseph's Health Care
state: Ontario
Study officials:
affiliation: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
name: Shannon McGuire, BScPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Western University
name: Laura Graham, MPT
role: PRINCIPAL_INVESTIGATOR
References: