UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061880 |
|---|---|
| Receipt number | R000070787 |
| Scientific Title | Relationship between Quadriceps Avoidance Gait and Physical Function in Patients after Anterior Cruciate Ligament ReconstructionSurgery |
| Date of disclosure of the study information | 2026/06/15 |
| Last modified on | 2026/06/11 18:39:22 |
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Basic information
Public title
Relationship between Quadriceps Avoidance Gait and Physical Function in Patients after Anterior Cruciate Ligament ReconstructionSurgery
Acronym
Relationship between Quadriceps Avoidance Gait and Physical Function in Patients after Anterior Cruciate Ligament ReconstructionSurgery
Scientific Title
Relationship between Quadriceps Avoidance Gait and Physical Function in Patients after Anterior Cruciate Ligament ReconstructionSurgery
Scientific Title:Acronym
Relationship between Quadriceps Avoidance Gait and Physical Function in Patients after Anterior Cruciate Ligament ReconstructionSurgery
Region
| Japan |
Condition
Condition
Patients After Anterior Cruciate Ligament Reconstruction
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to identify patients exhibiting quadriceps avoidance gait (QAG) following anterior cruciate ligament reconstruction (ACLR) using three-dimensional motion analysis and to investigate the relationships between QAG, physical function (range of motion, muscle strength, and pain), and motor performance. The findings of this study may help clarify the impact of QAG on motor performance in patients with anterior cruciate ligament injury.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire-based outcomes, pain, range of motion, muscle strength, and gait analysis at 3 and 5 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent anterior cruciate ligament reconstruction (ACLR) and attended the Department of Rehabilitation Medicine at Tokai University Hospital. Eligible participants were those who were judged capable of walking by a board-certified rehabilitation physician.
Key exclusion criteria
Patients with a history of psychiatric disorders, such as depression, whose symptoms were currently active.
Patients with classical higher brain dysfunction, including aphasia, apraxia, or agnosia.
Patients with significant cognitive impairment, such as severe deficits in attention or memory.
Patients who had undergone revision anterior cruciate ligament reconstruction (re-reconstruction).
Patients considered unsuitable for participation in the study by the principal investigator, co-investigators, or study physician.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Mizuno |
Organization
Department of Clinical Specialties, Tokai University School of Medicine, Kanagawa, Japan
Division name
Rehabilitation Science
Zip code
259-1193
Address
143,Shimokasuya,Isehara-shi,Kanagawa
TEL
0463-93-1121
mizuno.katsuhiro.r@tokai.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Tsutsui |
Organization
Tokai University Hospital
Division name
Department of Rehabilitation Technology
Zip code
259-1193
Address
143,Shimokasuya,Isehara-shi,Kanagawa
TEL
0463-93-1121
Homepage URL
r.tsutsu19@tokai.ac.jp
Sponsor or person
Institute
Tokai University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokai University Hospital
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
Tokai University Hospital
Address
143,Shimokasuya,Isehara-shi,Kanagawa
Tel
0463-93-1121
r.tsutsu19@tokai.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
| 2026 | Year | 06 | Month | 15 | 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
9
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
| 2020 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This prospective observational study included patients who underwent anterior cruciate ligament reconstruction (ACLR) at our institution between August 3, 2020, and March 31, 2026, and met the predefined inclusion criteria.
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070787
