Brain ConcussionNCT02317107
Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion
An observational study of Brain Concussion, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Read more about this study
- Who is it for?
- Ages 12 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Concussion
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2015to 1 Jan 2021
- Phase
- Observational
- 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 12 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients will come from Boston Children's Hospital and The Micheli Center for Sports Injury Prevention. Concussion will be defined consistent with the latest best-practice consensus statement on concussion in sport as a brain injury defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. Informed consent will be obtained after study explanation and sufficient time to answer all study-related questions at each respective location.
Who may be able to join
- Age between 12 and 40 years
- No history of concussion in the past year, and no lifetime history of more than 3 concussions
- Diagnosed with concussion within the past 21 days (concussion group only)
Who cannot join
- Lower extremity deficiency or injury, which may affect normal balance or gait
- History of permanent memory loss
- Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Longitudinal Examination of Dynamic Balance Control, Vestibular/Ocular Motor Function, and Activity Participation Following Concussion
Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations.
The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.
Read the detailed description
To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity.
During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.
- Conditions
- Brain Concussion
- Keywords
- Gait, Mild Traumatic Brain Injury, Post-Concussion Syndrome, Recovery of Function, Locomotion, Motor Activity
- Medical subject headings
- Brain Concussion, Post-Concussion Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Concussion | Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they receive a diagnosis of concussion, defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. If they agree to participate, they will be placed in the concussion group and assessed at each visit to the clinic. No intervention will be administered. | |
| Control | Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they come to the clinic for an injury unrelated to brain function or a lower extremity function (which may affect normal gait patterns). If they agree to participate, they will be placed in the control group and assessed at each visit to the clinic. No intervention will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic Balance Control
For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control.
Measured: 1 year
Secondary outcomes (3)
Temporal/Distance Gait Measurements
Stride velocity, stride length, gait cycle time, turning duration/velocity, and anticipatory postural adjustments will help to quantify gait stability in different conditions
Measured: 1 year
Vestibular-Ocular Motor Screen
The severity of symptom provocation in each condition of the vestibular-ocular motor test
Measured: 1 year
Weekly physical and cognitive activity scores
Scores rated by the patient will be calculated across their duration of participation in the study and used to associate the amount of activity participated in with the duration of time to recovery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2014 (estimated)
- Study start30 Jun 2015
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Brain ConcussionStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David R Howell, Boston Children's Hospital
- Investigators
- William P Meehan III, MD, Study chair, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02317107
- Sponsor's protocol ID
- IRB-P00016317
- Status last verified
- Feb 2021
- First submitted
- 11 Dec 2014
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Howell DR, O'Brien MJ, Raghuram A, Shah AS, Meehan WP 3rd. Near Point of Convergence and Gait Deficits in Adolescents After Sport-Related Concussion. Clin J Sport Med. 2018 May;28(3):262-267. doi: 10.1097/JSM.0000000000000439.
PubMed 28742610Howell DR, Stracciolini A, Geminiani E, Meehan WP 3rd. Dual-task gait differences in female and male adolescents following sport-related concussion. Gait Posture. 2017 May;54:284-289. doi: 10.1016/j.gaitpost.2017.03.034. Epub 2017 Apr 1.
PubMed 28384609Howell DR, Beasley M, Vopat L, Meehan WP 3rd. The Effect of Prior Concussion History on Dual-Task Gait following a Concussion. J Neurotrauma. 2017 Feb 15;34(4):838-844. doi: 10.1089/neu.2016.4609. Epub 2016 Sep 14.
PubMed 27541061Howell DR, Brilliant A, Berkstresser B, Wang F, Fraser J, Meehan WP 3rd. The Association between Dual-Task Gait after Concussion and Prolonged Symptom Duration. J Neurotrauma. 2017 Dec 1;34(23):3288-3294. doi: 10.1089/neu.2017.5191. Epub 2017 Oct 16.
PubMed 28895490Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.
PubMed 29154694
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Examination of Dynamic Balance Control, Vestibular/Ocular Motor Function, and Activity Participation Following Concussion
- ClinicalTrials.gov ID
- NCT02317107
- Acronym / sponsor ID
- IRB-P00016317
- Conditions
- Brain Concussion
- Keywords
- Gait, Mild Traumatic Brain Injury, Post-Concussion Syndrome, Recovery of Function, Locomotion, Motor Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 15 Dec 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.
Previous research and position statements have outlined the necessity of balance and gait testing in the post-concussion evaluation of athletes. However, many of the currently available balance testing techniques lack objectivity and sensitivity to the effects of concussion. Such balance impairments may exist following concussion due to disruption of vestibular and/or ocular motor systems. However, no clinically feasible tools have been longitudinally examined to detect gait balance control deficits or to investigate how vestibular or motor dysfunction may lead to gait imbalance. Additionally, participation in physical and cognitive activities post-concussion may affect recovery. While limited evidence exists to support this notion, further investigation is necessary to improve clinical management recommendations.
The proposed study will allow for the examination of tools which add value to post-concussion clinical evaluations and study-related outcomes will enhance the understanding of dynamic balance control and vestibular/ocular motor recovery, and their potential for implementation into concussion management protocols.
Detailed description
To address study hypotheses, the investigators plan to recruit subjects who have been diagnosed with a concussion by participating sports medicine physicians at the Boston Children's Hospital Sports Concussion Clinic. If patients elect to participate, they will undergo their regularly scheduled clinical examination along with two testing components requiring less than 15 minutes of additional time to complete: an instrumented gait balance assessment, a vestibular-ocular motor screen, and a weekly activity survey. Participants with concussion will be matched with control subjects who meet similar demographic characteristics and report to the clinic for other orthopedic injuries that do not affect brain function, gait, or either lower extremity.
During the assessment, participants will complete a protocol which measures balance control while walking and simultaneously completing a cognitive task, a vestibular-ocular motor ability, and physical and cognitive activity levels. As a need exists to develop protocols which utilize inexpensive, objective, and sensitive measurements to track concussion recovery, this study seeks to incorporate innovative and clinically feasible methods into the clinical examination of concussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concussion | – | –Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they receive a diagnosis of concussion, defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. If they agree to participate, they will be placed in the concussion group and assessed at each visit to the clinic. No intervention will be administered. |
| Control | – | –Individuals who report to the Division of Sports Medicine at Boston Children's Hospital will be identified for inclusion in the study if they come to the clinic for an injury unrelated to brain function or a lower extremity function (which may affect normal gait patterns). If they agree to participate, they will be placed in the control group and assessed at each visit to the clinic. No intervention will be administered. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients will come from Boston Children's Hospital and The Micheli Center for Sports Injury Prevention. Concussion will be defined consistent with the latest best-practice consensus statement on concussion in sport as a brain injury defined as a complex pathophysiological process affecting the brain, induced by biomechanical forces. Informed consent will be obtained after study explanation and sufficient time to answer all study-related questions at each respective location.
Key inclusion criteria (3 listed)
- Age between 12 and 40 years
- No history of concussion in the past year, and no lifetime history of more than 3 concussions
- Diagnosed with concussion within the past 21 days (concussion group only)
Key exclusion criteria (3 listed)
- Lower extremity deficiency or injury, which may affect normal balance or gait
- History of permanent memory loss
- Diagnosis of Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), learning disability, Down syndrome, or developmental delay
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dynamic Balance Control
Time frame: 1 year
For balance control measures, the primary data will come from accelerometers placed on specific anatomical landmarks to assess whole body movement. Peak accelerations and velocities of an estimated center-of-mass during gait under single-task and dual-task conditions will identify how divided attention tasks affect whole body balance control.
3 secondary outcomes
Temporal/Distance Gait Measurements
Time frame: 1 year
Vestibular-Ocular Motor Screen
Time frame: 1 year
Weekly physical and cognitive activity scores
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Background: PubMed 28742610Howell DR, O'Brien MJ, Raghuram A, Shah AS, Meehan WP 3rd. Near Point of Convergence and Gait Deficits in Adolescents After Sport-Related Concussion. Clin J Sport Med. 2018 May;28(3):262-267. doi: 10.1097/JSM.0000000000000439.
- Background: PubMed 28384609Howell DR, Stracciolini A, Geminiani E, Meehan WP 3rd. Dual-task gait differences in female and male adolescents following sport-related concussion. Gait Posture. 2017 May;54:284-289. doi: 10.1016/j.gaitpost.2017.03.034. Epub 2017 Apr 1.
- Background: PubMed 27541061Howell DR, Beasley M, Vopat L, Meehan WP 3rd. The Effect of Prior Concussion History on Dual-Task Gait following a Concussion. J Neurotrauma. 2017 Feb 15;34(4):838-844. doi: 10.1089/neu.2016.4609. Epub 2016 Sep 14.
- Background: PubMed 28895490Howell DR, Brilliant A, Berkstresser B, Wang F, Fraser J, Meehan WP 3rd. The Association between Dual-Task Gait after Concussion and Prolonged Symptom Duration. J Neurotrauma. 2017 Dec 1;34(23):3288-3294. doi: 10.1089/neu.2017.5191. Epub 2017 Oct 16.
- Background: PubMed 29154694Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.
- Individual participant dataSharing planned: No
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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.
William P Meehan III, MD study chair
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Concussion, run by Boston Children's Hospital at 1 site in United States.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Feb 2021. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dynamic Balance Control (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02317107, which also lists 5 linked publications.
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 4 Feb 2021.