UMIN-CTR Clinical Trial

Public title

Physiological and Psychological Evaluation Study of Return to Competition after Concussion in Children

Acronym

Physiological and Psychological Assessment of Return to Competition after Concussion in Children

Scientific Title

Physiological and Psychological Evaluation Study of Return to Competition after Concussion in Children: A Questionnaire Survey and Single-Group Nonrandomized Open Trial

Scientific Title:Acronym

Physiological and Psychological Assessment of Return to Competition after Concussion in Children: A Questionnaire and Single-Group Nonrandomized Open Trial

Region

Japan

Condition

mild concussion

Classification by specialty

Neurosurgery

Child

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Study 1: This is to conduct a questionnaire survey of families with children who have experienced concussion due to head trauma or other causes, either in the general population or in childhood with athletic characteristics.
Study 2: To observe and validate changes over time in non-subjective indicators using physiopsychological measures in children who have been cleared to return to competition after a concussion injury.

Basic objectives2

Others

Basic objectives -Others

Tests designed for physiological and psychological evaluation.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

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.

Key secondary outcomes

Study 1: Visualization and exploratory analysis from free descriptions.
Study 2: Multidimensional analytical evaluation and exploratory analysis from each factor.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment	Behavior,custom	Other

Interventions/Control_1

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 the athletic season).
a. Physiological and psychological/physical function assessment during the control period (before the start of the athletic season). b. Observational study of only injured subjects afterwards.
Observation Period 1: Days 1-7 post-injury (HRV, one other measurement, saliva at least every other day).
Observation period 2: First month of recovery period after gradual return to competition (every week), second month of recovery period (every 2 weeks), and evaluation measurements during each period.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

5

years-old

<=

Age-upper limit

15

years-old

>=

Gender

Male and Female

Key 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.

Key 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.

Target sample size

450

Name of lead principal investigator

1st name	Hiroto
Middle name
Last name	Fujiya

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

TEL

0449778111

Email

fujiya-1487@marianna-u.ac.jp

Name of contact person

1st name	Kanaka
Middle name
Last name	Yatabe

Organization

St. Marianna University School of Medicine

Division name

Department of Sports Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

TEL

0449778111

Homepage URL

Email

kanaka@marianna-u.ac.jp

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name

Organization

Ministry of education/
St. Marianna University School of Medicine

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

St. Marianna University School of Medicine, Graduate School and Research Promotion Division

Address

2-16-1, Sugao, Miyamae-ku, Kawasaki

Tel

044-977-8111

Email

k-shienbu.mail@marianna-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2022

Year

06

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

400

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Questionnaire survey: Out of 50,000 households with children, households with eligible children were selected by screening, and then the selected households were invited to participate in this survey, and responses were obtained from 400 of the eligible children.

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2021

Year

10

Month

01

Day

Date of IRB

2022

Year

06

Month

06

Day

Anticipated trial start date

2022

Year

06

Month

07

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2022

Year

06

Month

01

Day

Last modified on

2024

Year

06

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054612