Recruiting

Weighted Compression Vest

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT02084329

Conditions

Mild Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Weighted Compression Vest

Study Details

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.

Conditions

Mild Traumatic Brain Injury

Study ID

NCT02084329

Start date

Mar, 2014

Status verified date

Apr, 2020

Completion date

Apr, 2021

Anticipated

Primary completion date

Apr, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Weighted Compression Vest

Weighted Compression Vest

no intervention: Control

Interventions

Weighted Compression Vest

Primary outcome measure

  • Modified Clinical Test of Sensory Interaction on Balance(mCTSIB) [ Time Frame: 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. ]
  • The Functional Gait Assessment (FGA) [ Time Frame: 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). ]
  • The Rivermead Post-Concussion Questionnaire [ Time Frame: This outcome measure will be completed by participants prior to testing on intervention day 1 and 2 ]
  • The 10 Metre walk test [ Time Frame: 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. ]
  • Walking While Talking on a Gait Rite Mat [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Abbie Barron

519-685-4292abbie.barron@sjhc.london.on.ca

Locations

Parkwood Hospital- St. Joseph's Health Care

Recruiting

London, Ontario, Canada, N6C 5J1

Contacts

Shannon McGuire, PT, BHScPT

519 685-4292Shannon.McGuire@sjhc.london.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Jun 11, 2020

Last verified

Apr, 2020

Keywords

  • Physiotherapy
  • Physical therapy
  • neurotrauma rehabilitation
  • Rehabilitation
  • Balance
  • Balance Confidence
  • concussion
  • Post-Concussion
  • Mild Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2020-06-11.