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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000047952
Receipt No. R000054669
Scientific Title Comparison of a constraint-led training with visual-motor training in athletes with the history of anterior cruciate ligament reconstruction
Date of disclosure of the study information 2022/06/06
Last modified on 2022/06/05

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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