臨床研究等提出・公開システム

Japanese

Date of registration	Dec. 03, 2023
Last modified on	Dec. 03, 2023
Trial ID	jRCT1020230044

Scientific Title	Verification of the effectiveness of anterior cruciate ligament injury prevention training for high school basketball players
Public Title	Verification of the effectiveness of anterior cruciate ligament injury prevention training

Contact for Scientific Queries	Name	Eiichi Tsuda
	Affiliation	Hirosaki University Graduate School of Medicine
	Address	5 Zaifumachi, Hirosaki ,Aomori 036-8563 , Japan
	Telephone	+81-172395318
	E-mail	eiichi@hirosaki-u.ac.jp
Contact for Public Queries	Name	Henmi Rui
	Affiliation	Hirosaki University Hospital
	Address	53 Honcho, Hirosaki, Aomori 036-8563, Japan
	Telephone	+81-172395318
	E-mail	henmi.r@hirosaki-u.ac.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Dec. 11, 2021
Actual date of first enrollment		Dec. 11, 2021
Target sample size		60
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	uncontrolled control
	assignment	single assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Control group (60 people) A player who belonged to the high school girls' basketball club from April 2015 to March 2021. Intervention group (60 people) Players who will join the high school women's basketball club from April 2021 to April 2025.
	Exclusion Criteria	Athletes who received treatment for ACL injuries Athletes with orthopedic disorders whose symptoms may worsen if pre- and post-training evaluation measurements and preventive training are carried out Persons who have been unable to continue preventive training for six months due to leaving the club or for other reasons.
	Age Minimum	No limit
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		Anterior cruciate ligament injury
Intervention(s)		The intervention group will implement an ACL injury prevention program created by the applicant. This preventive training aims to strengthen the muscles around the hip joint, learn correct jumping and landing movements, and balance ability. In addition, provide guidance on correct form. Preventive training is conducted at least three times a week for six consecutive months. A physical therapist will provide training guidance on a regular basis (two or three times a month). On days when physical therapists are unable to visit, team coaches and managers provide training guidance. Regularly hold lectures on injury mechanisms and the knowledge necessary for prevention.
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		ACL injury rate (Athlete-exposures: AEs) AEs is calculated by multiplying the number of ACL injuries by 1000, taking into account the duration of sports activities, using the denominator as exposure time, which is the number of people multiplied by the number of days of practice/games, and the numerator as the number of ACL injuries. Calculate and compare the intervention group and control group. The number of participants in practices and games, as well as the number of days they were held, will be compiled from practice diaries for both the control and intervention groups.
Secondary Outcome(s)		Lower limb tightness Knee joint extension/flexion muscle strength Hip adduction/abduction muscle strength Dynamic lower limb balance Joint angles of lower limbs and trunk during one-leg landing and forward one-leg jump landing

Primary Sponsor	Not applicable

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Hirosaki University Graduate School of Medicine Ethics Committee
Address	5 Zaifucho Hirosaki , Aomori , Aomori
Telephone	+81-172-39-5044
E-Mail	rinri@hirosaki-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 10, 2021

Plan to share IPD	No
Plan description

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none