UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Acronym	Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Scientific Title	Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Scientific Title:Acronym	Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Region	Asia(except Japan)

Condition
Condition	pretest-posttest
Classification by specialty	Rehabilitation medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	functional performance (triple hop test)
Key secondary outcomes	dynamic balance (star test), biomechanics (knee flexion, ankle dorsiflexion, knee valgus, and ground reaction force), and psychological scales (kinesiophobia)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	CLT group /8 weeks
Interventions/Control_2	VMT group / 8 weeks
Interventions/Control_3	or control group / 8 weeks
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	35 years-old >=
Gender	Male
Key inclusion criteria	unilateral hamstring tendon autograft ACL reconstruction
Key exclusion criteria	having a concomitant injury to another knee structure (e.g. medial collateral ligament, meniscus) or experiencing a post-operative re-injury
Target sample size	45

Research contact person
Name of lead principal investigator	1st name amir Middle name Last name letafatkar
Organization	Kharazmi University
Division name	Sport medicine
Zip code	6664743
Address	tehran
TEL	00989195394692
Email	letafatkaramir@yahoo.com

Public contact
Name of contact person	1st name amir Middle name Last name letafatkar
Organization	Kharazmi University
Division name	sport medicine
Zip code	6664743
Address	tehran
TEL	00989357465993
Homepage URL
Email	letafatkaramir@yahoo.com

Sponsor
Institute	Kharazmi university
Institute
Department

Funding Source
Organization	Self-funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kharazmi university
Address	tehran
Tel	982122258085
Email	letafatkaramir@yahoo.com

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 06 Month 06 Day

Related information
URL releasing protocol	-
Publication of results	Unpublished

Result
URL related to results and publications	-
Number of participants that the trial has enrolled	45
Results	-
Results date posted	2022 Year 06 Month 05 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	-
Participant flow	-
Adverse events	-
Outcome measures	-
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2019 Year 07 Month 03 Day
Date of IRB	2019 Year 12 Month 15 Day
Anticipated trial start date	2020 Year 03 Month 21 Day
Last follow-up date	2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 06 Month 05 Day
Last modified on	2022 Year 06 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054669