Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest

NCT ID: NCT02084329

Last Updated: 2020-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2021-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Traumatic Brain Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Weighted Compression Vest

Weighted Compression Vest

Group Type EXPERIMENTAL

Weighted Compression Vest

Intervention Type DEVICE

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Weighted Compression Vest

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shannon McGuire, BScPT

Role: PRINCIPAL_INVESTIGATOR

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

Laura Graham, MPT

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

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Parkwood Hospital- St. Joseph's Health Care

London, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Abbie Barron

Role: CONTACT

519-685-4292 ext. 42179

Facility Contacts

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Shannon McGuire, PT, BHScPT

Role: primary

519 685-4292 ext. 42062

Other Identifiers

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104865

Identifier Type: -

Identifier Source: org_study_id

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