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

Primary Purpose

Mild Traumatic Brain Injury

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Weighted Compression Vest
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury focused on measuring Physiotherapy, Physical therapy, neurotrauma rehabilitation, Rehabilitation, Balance, Balance Confidence, concussion, Post-Concussion, Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parkwood Hospital- St. Joseph's Health CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Weighted Compression Vest

Control

Arm Description

Weighted Compression Vest

Outcomes

Primary Outcome Measures

Modified Clinical Test of Sensory Interaction on Balance(mCTSIB)
The modified Clinical Test of Sensory Interaction on Balance is designed to assess how well a person uses sensory inputs (vision, vestibular, somatosensory). As well, it provides some insight into whether each of the sensory system available for balance are being used effectively. Subjects attempt to maintain balance for 30 seconds in different set conditions involving their eyes open or closed, arms across chest, and feet together or in tandem stance. Tandem stance is when one foot's heel is in front of, and in contact with the other foot's toes. The amount of time the subject can maintain balance (up to 30 seconds) is recorded in the set condition. A subject is deemed as "unable to maintain balance" if, they step out of their set condition, or if the physiotherapist deems them to be swaying too much.
The Functional Gait Assessment (FGA)
The FGA assesses postural stability during various walking tasks. It is a 10-item gait assessment based on the Dynamic Gait Index. Each item is scored on a 4 item ordinal scale (0-3). The maximum score is 30 (normal) and the minimum score is 0 (severe impairment). The tasks have varying demands including gait with narrow base of support, gait with eyes closed, and gait while walking backwards and gait and pivot turn. The participant will perform each task, and the observer will give the participant a mark of 0-3, depending on how well the task is performed.
The Rivermead Post-Concussion Questionnaire
This is a survey that the participant fills out on their own. There are 16 items, with a 5 point ordinal scale from 0-4. "0" refers to not experienced at all, and "4" refers to a severe problem. The items are all symptoms that a person with a brain injury could possibly have. There is no time limit set upon this outcome measure, as the participant completes at his/her own pace.
The 10 Metre walk test
The 10 Metre Walk Test asks subjects to walk 10 meters. The time it takes for the subjects to reach 6 meters is recorded (to allow for acceleration and deceleration). The test can be performed at preferred walking speed or as fast as the subject can manage. The recorder must document if the subject chose to walk at preferred vs fast speed. Three trials are done, and averaged.
Walking While Talking on a Gait Rite Mat
Participants will ambulate 20 feet, turn around and return. Therefore each participant will walk 40 feet in total. Subjects will participate in three separate trials, in random order. The three trials include: 1-Walking 40 feet without an additional task.; 2-walking while talking (simple): walking while reciting alphabet aloud. 3; Walking while talking- complex: walking while reciting alternate letters of alphabet aloud. The scoring involves recording the time needed to complete the distance. Meanwhile, during these trials, the Gait Rite mat will record gait variability measures.

Secondary Outcome Measures

Anxiety Numerical Rating Scale
Participants will be asked to rate their anxiety on a scale of 0-10. "0" will be referred to as no anxiety and "10" is addressed as extreme anxiety.
Fatigue Numerical Rating Scale
Participants will be asked to rate their fatigue on a scale of 0-10. "0" will be referred to as no fatigue and "10" is addressed as extreme fatigue.

Full Information

First Posted
March 9, 2014
Last Updated
June 9, 2020
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02084329
Brief Title
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

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury
Keywords
Physiotherapy, Physical therapy, neurotrauma rehabilitation, Rehabilitation, Balance, Balance Confidence, concussion, Post-Concussion, Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Weighted Compression Vest
Arm Type
Experimental
Arm Description
Weighted Compression Vest
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Weighted Compression Vest
Primary Outcome Measure Information:
Title
Modified Clinical Test of Sensory Interaction on Balance(mCTSIB)
Description
The modified Clinical Test of Sensory Interaction on Balance is designed to assess how well a person uses sensory inputs (vision, vestibular, somatosensory). As well, it provides some insight into whether each of the sensory system available for balance are being used effectively. Subjects attempt to maintain balance for 30 seconds in different set conditions involving their eyes open or closed, arms across chest, and feet together or in tandem stance. Tandem stance is when one foot's heel is in front of, and in contact with the other foot's toes. The amount of time the subject can maintain balance (up to 30 seconds) is recorded in the set condition. A subject is deemed as "unable to maintain balance" if, they step out of their set condition, or if the physiotherapist deems them to be swaying too much.
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.
Title
The Functional Gait Assessment (FGA)
Description
The FGA assesses postural stability during various walking tasks. It is a 10-item gait assessment based on the Dynamic Gait Index. Each item is scored on a 4 item ordinal scale (0-3). The maximum score is 30 (normal) and the minimum score is 0 (severe impairment). The tasks have varying demands including gait with narrow base of support, gait with eyes closed, and gait while walking backwards and gait and pivot turn. The participant will perform each task, and the observer will give the participant a mark of 0-3, depending on how well the task is performed.
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).
Title
The Rivermead Post-Concussion Questionnaire
Description
This is a survey that the participant fills out on their own. There are 16 items, with a 5 point ordinal scale from 0-4. "0" refers to not experienced at all, and "4" refers to a severe problem. The items are all symptoms that a person with a brain injury could possibly have. There is no time limit set upon this outcome measure, as the participant completes at his/her own pace.
Time Frame
This outcome measure will be completed by participants prior to testing on intervention day 1 and 2
Title
The 10 Metre walk test
Description
The 10 Metre Walk Test asks subjects to walk 10 meters. The time it takes for the subjects to reach 6 meters is recorded (to allow for acceleration and deceleration). The test can be performed at preferred walking speed or as fast as the subject can manage. The recorder must document if the subject chose to walk at preferred vs fast speed. Three trials are done, and averaged.
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.
Title
Walking While Talking on a Gait Rite Mat
Description
Participants will ambulate 20 feet, turn around and return. Therefore each participant will walk 40 feet in total. Subjects will participate in three separate trials, in random order. The three trials include: 1-Walking 40 feet without an additional task.; 2-walking while talking (simple): walking while reciting alphabet aloud. 3; Walking while talking- complex: walking while reciting alternate letters of alphabet aloud. The scoring involves recording the time needed to complete the distance. Meanwhile, during these trials, the Gait Rite mat will record gait variability measures.
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.
Secondary Outcome Measure Information:
Title
Anxiety Numerical Rating Scale
Description
Participants will be asked to rate their anxiety on a scale of 0-10. "0" will be referred to as no anxiety and "10" is addressed as extreme anxiety.
Time Frame
Participants will be asked to rate their anxiety before, immediately after, and 24 hours after testing on days one and two.
Title
Fatigue Numerical Rating Scale
Description
Participants will be asked to rate their fatigue on a scale of 0-10. "0" will be referred to as no fatigue and "10" is addressed as extreme fatigue.
Time Frame
Participants will be asked to rate their fatigue before, immediately after, and 24 hours after testing on days one and two.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abbie Barron
Phone
519-685-4292
Ext
42179
Email
abbie.barron@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon McGuire, BScPT
Organizational Affiliation
Lawson Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Laura Graham, MPT
Organizational Affiliation
Western University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Parkwood Hospital- St. Joseph's Health Care
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 5J1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon McGuire, PT, BHScPT
Phone
519 685-4292
Ext
42062
Email
Shannon.McGuire@sjhc.london.on.ca

12. IPD Sharing Statement

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

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