mild concussion
Conditions
Interventions
Study 1: Questionnaire survey of past injuries or suspected cases of concussion (single-blind, backward-looking study
approximately 400 subjects) Study 2: Open prospective study, approximately 50 subjects. a. Physiological psychological and physical function assessment during the control period (before the start of
Sponsors
St. Marianna University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study 1: 1) Families of children who have experienced a mild concussion due to head trauma or other causes during childhood (during elementary or middle school), either as general students or as children who played sports of a competitive nature. 2) Subjects who have been fully informed of the study and have given their consent to participate in the study. 3) If the subject is a minor, the study will be explained to his/her surrogate, and his/her free and voluntary consent will be confirmed and obtained. Study 2: 1) General healthy subjects (pediatric athletes) 2) Subjects who are between the ages of 5 and 15 years at the time of obtaining consent. 3) Subjects who have been fully informed of the study and who have given their free and voluntary oral consent based on sufficient understanding of the subject's participation. (4) For minors, the study will be explained to the surrogate consenting party, who will be confirmed to have given his/her free and voluntary consent, and whose written consent has been obtained.
Exclusion criteria
Exclusion criteria: Research 1: 1) Those who are unable to continue to answer the questionnaire due to the progression of some disease or injury. 2) Those who have been judged by the principal investigator or the contract research organization to have discontinued the measurement. 2) Subjects who were judged by the principal investigator or the contract research organization to be in need of discontinuation of measurement. 3) Other subjects deemed inappropriate. Research 2 1) Subjects who are unable to continue measurement due to progression of some disease or injury. 2) Subjects whose measurement should be discontinued by the participating physician. 3) Other subjects deemed inappropriate by the participating physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Study 1: Simple tabulation of subjective and objective ratings of normal life after mild concussion or concussion recovery. Study 2: Changes in measured data over time. | — |
Secondary
| Measure | Time frame |
|---|---|
| Study 1: Visualization and exploratory analysis from free descriptions. Study 2: Multidimensional analytical evaluation and exploratory analysis from each factor. | — |
Countries
Japan
Contacts
Public ContactKanaka Yatabe
St. Marianna University School of Medicine Department of Sports Medicine
Outcome results
None listed