UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030074 |
|---|---|
| Receipt number | 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 | 2023/12/01 13:55:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hirohata.spt@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
140 athletes participated in this study (80 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
| 2019 | Year | 11 | Month | 29 | 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
Enrolling by invitation
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
| 2026 | 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
We are currently analyzing some of the data we have accumulated and preparing to publish it.
Management information
Registered date
| 2017 | Year | 11 | Month | 22 | Day |
Last modified on
| 2023 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.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 |
