UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055530 |
|---|---|
| Receipt number | R000063456 |
| Scientific Title | Evaluation of Lower Limb Joint Asymmetry and Coordination in Patients Post-ACL Reconstruction: The Utility of Markerless Motion Capture Systems for Longitudinal Assessment |
| Date of disclosure of the study information | 2024/09/18 |
| Last modified on | 2025/03/20 19:49:20 |
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Basic information
Public title
Evaluation of Lower Limb Joint Asymmetry and Coordination in Patients Post-ACL Reconstruction: The Utility of Markerless Motion Capture Systems for Longitudinal Assessment
Acronym
Evaluation of Lower Limb Joint Asymmetry and Coordination in Patients Post-ACL Reconstruction
Scientific Title
Evaluation of Lower Limb Joint Asymmetry and Coordination in Patients Post-ACL Reconstruction: The Utility of Markerless Motion Capture Systems for Longitudinal Assessment
Scientific Title:Acronym
Evaluation of Lower Limb Joint Asymmetry and Coordination in Patients Post-ACL Reconstruction
Region
| Japan |
Condition
Condition
Patients undergoing ACL Reconstruction
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Using a markerless motion capture system, this study aims to perform a 3D analysis of various movements in patients post-ACL reconstruction and examine the longitudinal changes in lower limb joint asymmetry and coordination.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
For each task movement, joint angles (ROM) and coordination patterns using the modified vector coding technique will be evaluated. The evaluation periods are pre-surgery and then monthly post-surgery until the patient completes rehabilitation and returns to sports. The task movements include walking, bilateral squats, single-leg squats, the Star Excursion Balance Test, bilateral vertical jumps, and single-leg hops. The joints analyzed will be the trunk, pelvis, hip, knee, and ankle.
Key secondary outcomes
To analyze the differences in joint movement waveforms between the surgical and non-surgical sides, the SPM1D package will be used.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Motion analysis using markerless motion capture systems
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
1) Patients undergoing ACL reconstruction at Asakura Sports Rehabilitation Clinic
2) Aged between 16 and 45, and actively participating in sports
3) Those who have read the consent form and provided informed consent (including parental consent for minors)
Key exclusion criteria
Any individual who meets one or more of the following conditions will be excluded.
1) Those with a history of surgery on the trunk or lower limbs
2) Those with concomitant injury to other ligaments
3) Those with neurological disorders
4) Those who do not consent to video recording
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Tajika |
Organization
Gunma University
Division name
Department of Rehabilitation, Graduate School of Health Sciences,
Zip code
3718511
Address
3-39-22 Showa-machi, Maebashi City, Gunma Prefecture
TEL
027-220-8945
tajika@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | yota |
| Middle name | |
| Last name | abe |
Organization
Asakura Sports Rehabilitation Clinic
Division name
Department of Rehabilitation
Zip code
3710811
Address
249-1 Asakura-machi, Maebashi City, Gunma Prefecture
TEL
027-265-6522
Homepage URL
yota.abe1987@gmail.com
Sponsor or person
Institute
Department of Rehabilitation, Graduate School of Health Sciences, Gunma University
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Medical Research Ethics Review Committee for Research Involving Human Subjects
Address
3-39-15 Showa-machi, Maebashi City, Gunma Prefecture
Tel
027-220-8740
hitotaisho-ciru@ml.gunma-u.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 | 09 | Month | 18 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 20 | 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
Management information
Registered date
| 2024 | Year | 09 | Month | 18 | Day |
Last modified on
| 2025 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063456
