UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052205 |
|---|---|
| Receipt number | R000059572 |
| Scientific Title | Trends and Associations between Kinesiophobia and Knee Function from Preoperatively to Three and Six Months Postoperatively in Patients post-ACL Reconstruction Surgery |
| Date of disclosure of the study information | 2023/09/13 |
| Last modified on | 2023/09/13 22:53:08 |
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Basic information
Public title
Trends and Associations between Kinesiophobia and Knee Function from Preoperatively to Three and Six Months Postoperatively in Patients post-ACL Reconstruction Surgery
Acronym
Trends and Associations between Kinesiophobia and Knee Function from Preoperatively to Three and Six Months Postoperatively in Patients post-ACL Reconstruction Surgery
Scientific Title
Trends and Associations between Kinesiophobia and Knee Function from Preoperatively to Three and Six Months Postoperatively in Patients post-ACL Reconstruction Surgery
Scientific Title:Acronym
Trends and Associations between Kinesiophobia and Knee Function from Preoperatively to Three and Six Months Postoperatively in Patients post-ACL Reconstruction Surgery
Region
| Japan |
Condition
Condition
ACLR
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to clarify the relationship between the transition of kinesiophobia and knee joint function from the preoperative period to three months postoperative, the time to resume running, six months post-ACLR, and the goal time to resume sports.
Basic objectives2
Others
Basic objectives -Others
Clarify pre- and postoperative TSK-11 trends
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TSK-11 preoperatively, 3 months postoperatively, and 6 months postoperatively
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
| 13 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The subjects of this study were patients who underwent anatomical single-bundle ACL reconstruction (Semitendinosus Gracilis: STG and Bone-patellar tendon-bone: BTB) between January 2015, and April 2016, with a Tegner activity score of 7 or higher.
Key exclusion criteria
previous ACL reconstruction, composite ligament reconstruction performed at the same time as the ACL reconstruction, and bilateral reconstruction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Isaji |
Organization
Bukkyo University
Division name
School of health science
Zip code
604-8418
Address
7 Nishinokyo Higashi-Tsugao-cho, 7 Nishinokyo Tsugao-cho, Nakagyo-ku, Kyoto-shi, Kyoto
TEL
075-491-2141
yisaji617@gmail.com
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Isaji |
Organization
Bukkyo University
Division name
School of health science
Zip code
604-8418
Address
7 Nishinokyo Higashi-Tsugao-cho, 7 Nishinokyo Tsugao-cho, Nakagyo-ku, Kyoto-shi, Kyoto
TEL
075-491-2141
Homepage URL
yisaji617@gmail.com
Sponsor or person
Institute
Bukkyo 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
Bukkyo University
Address
7 Nishinokyo Higashi-Tsugao-cho, 7 Nishinokyo Tsugao-cho, Nakagyo-ku, Kyoto-shi, Kyoto
Tel
075-491-2141
yisaji617@gmail.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
| 2023 | Year | 09 | Month | 13 | 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
54
Results
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
Completed
Date of protocol fixation
| 2017 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059572
