UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053838 |
|---|---|
| Receipt number | R000061384 |
| Scientific Title | Japanese translation and cross-cultural adaptation of the TENDINopathy Severity Assessment-Achillesand and Achilles Tendon Total Rupture Score |
| Date of disclosure of the study information | 2024/03/13 |
| Last modified on | 2024/03/12 17:36:34 |
* 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
Japanese translation and cross-cultural adaptation of the TENDINopathy Severity Assessment-Achilles and the Achilles Tendon Total Rupture Score
Acronym
Japanese translation and cross-cultural adaptation of the TENDINS-A and ATRS
Scientific Title
Japanese translation and cross-cultural adaptation of the TENDINopathy Severity Assessment-Achillesand and Achilles Tendon Total Rupture Score
Scientific Title:Acronym
Japanese translation and cross-cultural adaptation of the TENDINS-A and ATRS
Region
| Japan |
Condition
Condition
Achilles tendinopathy and Achilles tendon tear
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to cross-culturally adapt the TENDINS-A and ATRS in Japanese.
Basic objectives2
Others
Basic objectives -Others
This study aims to examine reliability of the Japanese versiton of the TENDINS-A and ATRS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The results of each questionnaire will be correlated with the Foot and Ankle Ability Measure for validity, and the intraclass correlation coefficient between the first and second responses will be calculated for reproducibility.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Achilles tendinopathy and Achilles tendon tear
Key exclusion criteria
immediatery after tendon tear
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tomonobu |
| Middle name | |
| Last name | Ishigaki |
Organization
Niigata University of Health and Welfare
Division name
department of Physical Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4309
tomonobu-ishigaki@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomonobu |
| Middle name | |
| Last name | Ishigaki |
Organization
Niigata University of Health and Welfare
Division name
Department of Physical Therapy
Zip code
950-3198
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
TEL
025-257-4309
Homepage URL
tomonobu-ishigaki@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
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
Niigata University of Health and Welfare
Address
1398, Shimami-cho, Kita-ku, Niigata City, Niigata
Tel
025-257-4309
soumu@nuhw.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
| 2024 | Year | 03 | 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
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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061384
