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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030074
Receipt No. R000034283
Scientific Title Investigation of the postoperative-alteration of single-leg hopping capability in anterior cruciate ligament-reconstructed patients
Date of disclosure of the study information 2017/11/22
Last modified on 2019/05/27

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Basic information
Public title Investigation of the postoperative-alteration of single-leg hopping capability in anterior cruciate ligament-reconstructed patients
Acronym Investigation of the postoperative-alteration of single-leg hopping capability in anterior cruciate ligament-reconstructed patients
Scientific Title Investigation of the postoperative-alteration of single-leg hopping capability in anterior cruciate ligament-reconstructed patients
Scientific Title:Acronym Investigation of the postoperative-alteration of single-leg hopping capability in anterior cruciate ligament-reconstructed patients
Region
Japan

Condition
Condition Anterior cruciate ligament tear
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate postoperative-alteration of single-leg hoppong capability in anterior cruciate ligament-reconstructed patients
Basic objectives2 Others
Basic objectives -Others To investigate the usability of evaluation
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Capability of single-leg hopping of ACL reconstructed-patiens at 5 month or over after surgery
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Eligibility
Age-lower limit
16 years-old <=
Age-upper limit
45 years-old >=
Gender Male and Female
Key inclusion criteria Tegner activity scale is 5 or over
Key exclusion criteria Have pain and fear during single-leg hopping task
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Hirohata
Organization Tokyo Medical and Dental University
Division name Clinical Center for Sports Medicine and Sports Dentistry
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519 Japan
TEL 03-5803-4721
Email hirohata.spt@tmd.ac.jp

Public contact
Name of contact person
1st name Kenji
Middle name
Last name Hirohata
Organization Tokyo Medical and Dental University
Division name Clinical Center for Sports Medicine and Sports Dentistry
Zip code 113-8519
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519 Japan
TEL 03-5803-4721
Homepage URL
Email hirohata.spt@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization None
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 Tokyo Medical and Dental University
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo 113-8519 Japan
Tel 03-5803-7102
Email syomu1.adm@tmd.ac.jp

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
2017 Year 11 Month 22 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
Results
68 athletes participated in this study (39 females, age 24.5years, height 166.3cm, weight 62.8kg, time from surgery 212.3days).The limb symmetry index of reactive strength index (RSI) was 85.6%.The time from surgery was not associate with limbs symmetry index of RSI.The RSI in the involved limb was significantly lower than that in the uninvolved limb.
Results date posted
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 Open public recruiting
Date of protocol fixation
2017 Year 02 Month 22 Day
Date of IRB
2017 Year 02 Month 22 Day
Anticipated trial start date
2017 Year 02 Month 28 Day
Last follow-up date
2021 Year 06 Month 29 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Now recruiting

Management information
Registered date
2017 Year 11 Month 22 Day
Last modified on
2019 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034283

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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