Mild Traumatic Brain InjuryNCT02084329
Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest
A study testing Weighted Compression Vest in people with Mild Traumatic Brain Injury, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mild Traumatic Brain Injury
- What is being tested?
- Weighted Compression Vest
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2014to Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Other pre-existing vestibular problems. Other diagnosed orthopedic injuries or significant health conditions that impair balance or mobility.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Parkwood Hospital- St. Joseph's Health Care
London, Ontario, N6C 5J1
Shannon McGuire, PT, BHScPT, 519 685-4292 ext. 42062, Shannon.McGuire@sjhc.london.on.ca
About this study
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
- Being tested
- Weighted Compression Vest
- Keywords
- Physiotherapy, Physical therapy, neurotrauma rehabilitation, Rehabilitation, Balance, Balance Confidence, concussion, Post-Concussion, Mild Traumatic Brain Injury
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weighted Compression VestDevice
| Study group | Role | What they receive |
|---|---|---|
| Weighted Compression Vest | Experimental | Weighted Compression Vest Receives: Device: Weighted Compression Vest |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
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.
Measured: This outcome measure will be completed by participants prior to testing on intervention day 1 and 2
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.
Measured: 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
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.
Measured: 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 (2)
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.
Measured: Participants will be asked to rate their anxiety before, immediately after, and 24 hours after testing on days one and two.
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.
Measured: Participants will be asked to rate their fatigue before, immediately after, and 24 hours after testing on days one and two.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shannon McGuire, BScPT, Principal investigator, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sLaura Graham, MPT, Principal investigator, Western University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084329
- Sponsor's protocol ID
- 104865
- Status last verified
- Apr 2020
- First submitted
- 9 Mar 2014
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance and Mild Traumatic Brain Injury: The Effect of a Weighted Compression Vest
- ClinicalTrials.gov ID
- NCT02084329
- Acronym / sponsor ID
- 104865
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Physiotherapy, Physical therapy, neurotrauma rehabilitation, Rehabilitation, Balance, Balance Confidence, concussion, Post-Concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weighted Compression Vest | Experimental | Device: Weighted Compression VestWeighted Compression Vest |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Other pre-existing vestibular problems. Other diagnosed orthopedic injuries or significant health conditions that impair balance or mobility.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weighted Compression Vest | Device | Weighted Compression Vest |
Primary outcome
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 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)
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 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
Time frame: This outcome measure will be completed by participants prior to testing on intervention day 1 and 2
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
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.
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
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.
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.
2 secondary outcomes
Anxiety Numerical Rating Scale
Time frame: Participants will be asked to rate their anxiety before, immediately after, and 24 hours after testing on days one and two.
Fatigue Numerical Rating Scale
Time frame: Participants will be asked to rate their fatigue before, immediately after, and 24 hours after testing on days one and two.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shannon McGuire, BScPT principal investigator
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Laura Graham, MPT principal investigator
Western University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weighted Compression Vest in people with Mild Traumatic Brain Injury, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abbie Barron (519-685-4292 ext. 42179, abbie.barron@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2020.