- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02317107
Examination of Balance, Vestibular, and Ocular Functions and Activity Following Concussion
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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Contatti e Sedi
Luoghi di studio
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Massachusetts
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Boston, Massachusetts, Stati Uniti, 02115
- Boston Children's Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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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.
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Controllo dinamico dell'equilibrio
Lasso di tempo: 1 anno
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Per le misure di controllo dell'equilibrio, i dati primari proverranno da accelerometri posizionati su punti di riferimento anatomici specifici per valutare il movimento dell'intero corpo.
Le accelerazioni e le velocità di picco di un centro di massa stimato durante l'andatura in condizioni di compito singolo e doppio identificheranno come i compiti di attenzione divisa influenzano il controllo dell'equilibrio dell'intero corpo.
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1 anno
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Temporal/Distance Gait Measurements
Lasso di tempo: 1 year
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Stride velocity, stride length, gait cycle time, turning duration/velocity, and anticipatory postural adjustments will help to quantify gait stability in different conditions
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1 year
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Vestibular-Ocular Motor Screen
Lasso di tempo: 1 year
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The severity of symptom provocation in each condition of the vestibular-ocular motor test
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1 year
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Weekly physical and cognitive activity scores
Lasso di tempo: 1 year
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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
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1 year
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Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: William P Meehan III, MD, Boston Children's Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Howell 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.
- 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.
- Howell 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.
- Howell 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.
- Berkner 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.
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IRB-P00016317
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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