Concussion, MildNCT06340100
Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes
An observational study of Concussion, Mild and Vestibular Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports. Read more about this study
- Who is it for?
- Ages 18 to 36 years
- Conditions the study is for
- Concussion, Mild, Vestibular Impairment, Cognitive Impairment
- What is being tested?
- find association between vestibular impairment , cognitive fiunction with concussin
- How many people
- 115 participants
- Where
- 1 sitePakistan
- Study dates
- 23 Mar 2024to 2 Jun 2024
- 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 18 to 36 years
- All sexes
- Adult
Study population: This includes information such as age, gender, and ethnicity of the athletes. Understanding the demographics of the population helps in assessing the generalizability of the study findings across different groups. The number, severity, and timing of previous concussions experienced by each athlete. This helps in stratifying the participants based on concussion history and assessing potential cumulative effects. Pre-existing medical conditions, history of previous injuries (e.g., musculoskeletal injuries), and baseline cognitive and physical performance measures. This information allows for controlling potential confounding variables and assessing the impact of concussion independently.
Who may be able to join
- athletes actively involved in sports at age of 18 to 35
- active players in contact sports
Who cannot join
- Concussion other than sports
- History of recent fractures.
- Participants having neurological deficits
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
HAYATABAD Sports complex
Peshawar, Khyber Pakhtun Khawan, 24730
Nadia Ishtiaq, MSOMPT, +922486977541, Nadia.Ishtiaq@riphah.edu.pk
MAHEEN GUL, MSSPT*, +923319533510
About this study
This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports.
Read the detailed description
The association of a history of concussions with vestibular impairment and cognitive function in sports athletes is a significant area of research due to the potential long-term consequences of head injuries in contact sports.
Vestibular impairment refers to disruptions in the balance and spatial orientation system of the inner ear, which can result from head trauma. Cognitive function encompasses various mental processes, including memory, attention, and decision-making, which may be affected by concussions.
This study aims to examine how prior concussions relate to both vestibular impairment and cognitive function in athletes participating in sports. Researchers typically employ a combination of self-reported concussion history, clinical assessments of vestibular function, and standardized cognitive tests to evaluate participants.
Findings from such studies can provide valuable insights into the potential effects of concussions on athletes' balance, spatial awareness, and cognitive abilities. Understanding these associations can inform concussion management protocols, rehabilitation strategies, and preventive measures in sports settings.
Furthermore, this research may contribute to the development of targeted interventions aimed at improving vestibular rehabilitation and cognitive training for athletes with a history of concussions. By identifying and addressing these potential deficits early, athletes may reduce their risk of long-term complications and optimize their performance and well-being in sports.
- Being tested
- find association between vestibular impairment , cognitive fiunction with concussin
- Medical subject headings
- Brain Concussion, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
find association between vestibular impairment , cognitive fiunction with concussinOther
Also called identify concussion and find asociation through scoat 6 ad Cantu
SCOAT 6 is a standardized tool used for evaluating athletes suspected of having a concussion. It includes a variety of components such as symptom evaluation, cognitive assessment, balance evaluation, and a neck examination. it helps in assessing the severity of the injury, tracking recovery, and making return-to-play decisions. Dr. Robert Cantu, a prominent figure in sports concussion research, has proposed guidelines for the management of concussions. These guidelines typically involve recommendations for the evaluation, treatment, and return-to-play decisions for athletes who have sustained concussions
| Study group | Role | What they receive |
|---|---|---|
| concussed contact sports athlete | Informed Consent: Participants are provided with information about the study, including its purpose, procedures, potential risks, and benefits. They are given the opportunity to ask questions and provide informed consent before participating.
Baseline Assessments: Before any interventions or assessments, participants undergo baseline evaluations of their vestibular function and cognitive abilities. This helps establish a starting point for comparison and allows researchers to identify any pre-existing impairments.
Concussion History Questionnaires: Participants complete questionnaires or interviews to provide detailed information about their history of concussions, including the number, severity, and timing of each injury. Receives: Other: find association between vestibular impairment , cognitive fiunction with concussin |
What is being measured
The primary outcome is the main question the study is designed to answer.
CANTU
The Cantu guidelines, named after Dr. Robert Cantu, are a set of recommendations for the management of concussions in sports. Dr. Cantu, a renowned neurosurgeon and concussion expert, has contributed significantly to the understanding and treatment of concussions, particularly in the field of sports medicine. While there isn't a single document titled "Cantu Description," Dr. Cantu's work encompasses various aspects of concussion management, including diagnosis, treatment, and return-to-play protocols.
Measured: 3 DAYS
Sports concussion office assesment tool 6
SCOAT 6 is a standardized tool used for evaluating athletes suspected of having a concussion. It includes a variety of components such as symptom evaluation, cognitive assessment, balance evaluation, and a neck examination. it helps in assessing the severity of the injury, tracking recovery, and making return-to-play decisions.
Measured: 3-30days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start23 Mar 2024
- Primary completion23 Apr 2024 (estimated)
- Study completion2 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Concussion, MildStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maheen gul, MSSPT*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06340100
- Sponsor's protocol ID
- REC/MS-PT/01832
- Status last verified
- Mar 2024
- First submitted
- 25 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Individual data sharing
- No
Publications
Whitney SL, Eagle SR, Marchetti G, Mucha A, Collins MW, Kontos AP; CARE Consortium Investigators. Association of acute vestibular/ocular motor screening scores to prolonged recovery in collegiate athletes following sport-related concussion. Brain Inj. 2020 May 11;34(6):840-845. doi: 10.1080/02699052.2020.1755055. Epub 2020 Apr 21.
PubMed 32315218Taylor KM, Kioumourtzoglou MA, Clover J, Coull BA, Dennerlein JT, Bellinger DC, Weisskopf MG. Concussion History and Cognitive Function in a Large Cohort of Adolescent Athletes. Am J Sports Med. 2018 Nov;46(13):3262-3270. doi: 10.1177/0363546518798801. Epub 2018 Sep 19.
PubMed 30230912Price AM, Knell G, Caze TJ 2nd, Abt JP, Loveland D, Burkhart SO. Exploring Vestibular/Ocular and Cognitive Dysfunction as Prognostic Factors for Protracted Recovery in Sports-Related Concussion Patients Aged 8 to 12 Years. Clin J Sport Med. 2022 Jul 1;32(4):408-414. doi: 10.1097/JSM.0000000000000975. Epub 2021 Sep 8.
PubMed 34516435Yorke AM, Smith L, Babcock M, Alsalaheen B. Validity and Reliability of the Vestibular/Ocular Motor Screening and Associations With Common Concussion Screening Tools. Sports Health. 2017 Mar/Apr;9(2):174-180. doi: 10.1177/1941738116678411. Epub 2016 Nov 11.
PubMed 27834667Eagle SR, Nindl BC, Johnson CD, Kontos AP, Connaboy C. Does Concussion Affect Perception-Action Coupling Behavior? Action Boundary Perception as a Biomarker for Concussion. Clin J Sport Med. 2021 May 1;31(3):273-280. doi: 10.1097/JSM.0000000000000731.
PubMed 30829684Zhang Y, Ma Y, Chen S, Liu X, Kang HJ, Nelson S, Bell S. Long-Term Cognitive Performance of Retired Athletes with Sport-Related Concussion: A Systematic Review and Meta-Analysis. Brain Sci. 2019 Aug 13;9(8):199. doi: 10.3390/brainsci9080199.
PubMed 31412586Louey AG, Cromer JA, Schembri AJ, Darby DG, Maruff P, Makdissi M, Mccrory P. Detecting cognitive impairment after concussion: sensitivity of change from baseline and normative data methods using the CogSport/Axon cognitive test battery. Arch Clin Neuropsychol. 2014 Aug;29(5):432-41. doi: 10.1093/arclin/acu020. Epub 2014 May 9.
PubMed 24813184Harmon KG, Clugston JR, Dec K, Hainline B, Herring S, Kane SF, Kontos AP, Leddy JJ, McCrea M, Poddar SK, Putukian M, Wilson JC, Roberts WO. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019 Feb;53(4):213-225. doi: 10.1136/bjsports-2018-100338.
PubMed 30705232Bryan MA, Rowhani-Rahbar A, Comstock RD, Rivara F; Seattle Sports Concussion Research Collaborative. Sports- and Recreation-Related Concussions in US Youth. Pediatrics. 2016 Jul;138(1):e20154635. doi: 10.1542/peds.2015-4635. Epub 2016 Jun 20.
PubMed 27325635Kerr ZY, Roos KG, Djoko A, Dalton SL, Broglio SP, Marshall SW, Dompier TP. Epidemiologic Measures for Quantifying the Incidence of Concussion in National Collegiate Athletic Association Sports. J Athl Train. 2017 Mar;52(3):167-174. doi: 10.4085/1062-6050-51.6.05. Epub 2016 Jun 22.
PubMed 27331336
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of History of Concussion With Vestibular Impairment and Cognitive Function in Sports Athletes
- ClinicalTrials.gov ID
- NCT06340100
- Acronym / sponsor ID
- REC/MS-PT/01832
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 23 Mar 2024 (actual)
- Primary completion
- 23 Apr 2024 (estimated)
- Study completion
- 2 Jun 2024 (estimated)
- First posted
- 1 Apr 2024 (actual)
- 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.
This study investigates the potential relationship between prior concussions and their impact on both vestibular function and cognitive abilities in athletes participating in sports.
Detailed description
The association of a history of concussions with vestibular impairment and cognitive function in sports athletes is a significant area of research due to the potential long-term consequences of head injuries in contact sports.
Vestibular impairment refers to disruptions in the balance and spatial orientation system of the inner ear, which can result from head trauma. Cognitive function encompasses various mental processes, including memory, attention, and decision-making, which may be affected by concussions.
This study aims to examine how prior concussions relate to both vestibular impairment and cognitive function in athletes participating in sports. Researchers typically employ a combination of self-reported concussion history, clinical assessments of vestibular function, and standardized cognitive tests to evaluate participants.
Findings from such studies can provide valuable insights into the potential effects of concussions on athletes' balance, spatial awareness, and cognitive abilities. Understanding these associations can inform concussion management protocols, rehabilitation strategies, and preventive measures in sports settings.
Furthermore, this research may contribute to the development of targeted interventions aimed at improving vestibular rehabilitation and cognitive training for athletes with a history of concussions. By identifying and addressing these potential deficits early, athletes may reduce their risk of long-term complications and optimize their performance and well-being in sports.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| concussed contact sports athlete | – | Other: find association between vestibular impairment , cognitive fiunction with concussinInformed Consent: Participants are provided with information about the study, including its purpose, procedures, potential risks, and benefits. They are given the opportunity to ask questions and provide informed consent before participating. Baseline Assessments: Before any interventions or assessments, participants undergo baseline evaluations of their vestibular function and cognitive abilities. This helps establish a starting point for comparison and allows researchers to identify any pre-existing impairments. Concussion History Questionnaires: Participants complete questionnaires or interviews to provide detailed information about their history of concussions, including the number, severity, and timing of each injury. |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- All
- Age groups
- Adult
- Study population
- This includes information such as age, gender, and ethnicity of the athletes. Understanding the demographics of the population helps in assessing the generalizability of the study findings across different groups. The number, severity, and timing of previous concussions experienced by each athlete. This helps in stratifying the participants based on concussion history and assessing potential cumulative effects. Pre-existing medical conditions, history of previous injuries (e.g., musculoskeletal injuries), and baseline cognitive and physical performance measures. This information allows for controlling potential confounding variables and assessing the impact of concussion independently.
Key inclusion criteria (2 listed)
- athletes actively involved in sports at age of 18 to 35
- active players in contact sports
Key exclusion criteria (3 listed)
- Concussion other than sports
- History of recent fractures.
- Participants having neurological deficits
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 |
|---|---|---|
| find association between vestibular impairment , cognitive fiunction with concussinAlso: identify concussion and find asociation through scoat 6 ad CantuSCOAT 6 is a standardized tool used for evaluating athletes suspected of having a concussion. It includes a variety of components such as symptom evaluation, cognitive assessment, balance evaluation, and a neck examination. it helps in assessing the severity of the injury, tracking recovery, and making return-to-play decisions. Dr. Robert Cantu, a prominent figure in sports concussion research, has proposed guidelines for the management of concussions. These guidelines typically involve recommendations for the evaluation, treatment, and return-to-play decisions for athletes who have sustained concussions | Other | concussed contact sports athlete |
Primary outcome
CANTU
Time frame: 3 DAYS
The Cantu guidelines, named after Dr. Robert Cantu, are a set of recommendations for the management of concussions in sports. Dr. Cantu, a renowned neurosurgeon and concussion expert, has contributed significantly to the understanding and treatment of concussions, particularly in the field of sports medicine. While there isn't a single document titled "Cantu Description," Dr. Cantu's work encompasses various aspects of concussion management, including diagnosis, treatment, and return-to-play protocols.
Sports concussion office assesment tool 6
Time frame: 3-30days
SCOAT 6 is a standardized tool used for evaluating athletes suspected of having a concussion. It includes a variety of components such as symptom evaluation, cognitive assessment, balance evaluation, and a neck examination. it helps in assessing the severity of the injury, tracking recovery, and making return-to-play decisions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 32315218Whitney SL, Eagle SR, Marchetti G, Mucha A, Collins MW, Kontos AP; CARE Consortium Investigators. Association of acute vestibular/ocular motor screening scores to prolonged recovery in collegiate athletes following sport-related concussion. Brain Inj. 2020 May 11;34(6):840-845. doi: 10.1080/02699052.2020.1755055. Epub 2020 Apr 21.
- Background: PubMed 30230912Taylor KM, Kioumourtzoglou MA, Clover J, Coull BA, Dennerlein JT, Bellinger DC, Weisskopf MG. Concussion History and Cognitive Function in a Large Cohort of Adolescent Athletes. Am J Sports Med. 2018 Nov;46(13):3262-3270. doi: 10.1177/0363546518798801. Epub 2018 Sep 19.
- Background: PubMed 34516435Price AM, Knell G, Caze TJ 2nd, Abt JP, Loveland D, Burkhart SO. Exploring Vestibular/Ocular and Cognitive Dysfunction as Prognostic Factors for Protracted Recovery in Sports-Related Concussion Patients Aged 8 to 12 Years. Clin J Sport Med. 2022 Jul 1;32(4):408-414. doi: 10.1097/JSM.0000000000000975. Epub 2021 Sep 8.
- Background: PubMed 27834667Yorke AM, Smith L, Babcock M, Alsalaheen B. Validity and Reliability of the Vestibular/Ocular Motor Screening and Associations With Common Concussion Screening Tools. Sports Health. 2017 Mar/Apr;9(2):174-180. doi: 10.1177/1941738116678411. Epub 2016 Nov 11.
- Background: PubMed 30829684Eagle SR, Nindl BC, Johnson CD, Kontos AP, Connaboy C. Does Concussion Affect Perception-Action Coupling Behavior? Action Boundary Perception as a Biomarker for Concussion. Clin J Sport Med. 2021 May 1;31(3):273-280. doi: 10.1097/JSM.0000000000000731.
- Background: PubMed 31412586Zhang Y, Ma Y, Chen S, Liu X, Kang HJ, Nelson S, Bell S. Long-Term Cognitive Performance of Retired Athletes with Sport-Related Concussion: A Systematic Review and Meta-Analysis. Brain Sci. 2019 Aug 13;9(8):199. doi: 10.3390/brainsci9080199.
- Background: PubMed 24813184Louey AG, Cromer JA, Schembri AJ, Darby DG, Maruff P, Makdissi M, Mccrory P. Detecting cognitive impairment after concussion: sensitivity of change from baseline and normative data methods using the CogSport/Axon cognitive test battery. Arch Clin Neuropsychol. 2014 Aug;29(5):432-41. doi: 10.1093/arclin/acu020. Epub 2014 May 9.
- Background: PubMed 30705232Harmon KG, Clugston JR, Dec K, Hainline B, Herring S, Kane SF, Kontos AP, Leddy JJ, McCrea M, Poddar SK, Putukian M, Wilson JC, Roberts WO. American Medical Society for Sports Medicine position statement on concussion in sport. Br J Sports Med. 2019 Feb;53(4):213-225. doi: 10.1136/bjsports-2018-100338.
- Background: PubMed 27325635Bryan MA, Rowhani-Rahbar A, Comstock RD, Rivara F; Seattle Sports Concussion Research Collaborative. Sports- and Recreation-Related Concussions in US Youth. Pediatrics. 2016 Jul;138(1):e20154635. doi: 10.1542/peds.2015-4635. Epub 2016 Jun 20.
- Background: PubMed 27331336Kerr ZY, Roos KG, Djoko A, Dalton SL, Broglio SP, Marshall SW, Dompier TP. Epidemiologic Measures for Quantifying the Incidence of Concussion in National Collegiate Athletic Association Sports. J Athl Train. 2017 Mar;52(3):167-174. doi: 10.4085/1062-6050-51.6.05. Epub 2016 Jun 22.
- Individual participant dataSharing planned: No
Related trials for Concussion, Mild
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Maheen gul, MSSPT* principal investigator
Riphah International University
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 Concussion, Mild and Vestibular Impairment, run by Riphah International University at 1 site in Pakistan.
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 2 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: status not confirmed, as of the sponsor's last update on 1 Apr 2024. 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 Pakistan. 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 Nadia Ishtiaq, MSOMPT (03486977541, Nadia.ishtiaq@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CANTU (time frame: 3 DAYS). The study lists 2 primary outcomes in all. 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 NCT06340100, which also lists 10 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 1 Apr 2024.