UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057074 |
|---|---|
| Receipt number | R000057871 |
| Scientific Title | Reliability of Single-leg Drop Landing Task Considering Difference in Physique. |
| Date of disclosure of the study information | 2025/02/19 |
| Last modified on | 2025/02/19 12:22:06 |
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Basic information
Public title
Reliability of Single-leg Drop Landing Task Considering Difference in Physique.
Acronym
Reliability of Single-leg Drop Landing Task Considering Difference in Physique.
Scientific Title
Reliability of Single-leg Drop Landing Task Considering Difference in Physique.
Scientific Title:Acronym
Reliability of Single-leg Drop Landing Task Considering Difference in Physique.
Region
| Japan |
Condition
Condition
Health Person
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A Single Leg Drop Landing (SDL) task that takes into account differences in the physique of individual subjects is set up, and the knee joint is measured using a three-dimensional movement analyser for kinematics and kinematic analysis.Then, a method of performing the SDL task to quantitatively load the knee joints of test subjects of different physiques will be investigated.
Basic objectives2
Others
Basic objectives -Others
We will examine the differences in accuracy between the Plug-in Gait Model, which is the conventional method for calculating kinematic parameters, and the OSCST and SCoRE and SARA Combined Approach (OSSCA), which is expected to provide more detailed calculations.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The three-dimensional ground reaction force (GRF) component, knee extension moment (KEM) and knee flexion angle were used as the SDL assessment items. The above evaluation items are calculated using the Optinum Common Shape Technique (OCST) and Symmetrical Center of Rotation Estimation (SARA) to calculate the rigid body segment model and the hip and knee joint centres and knee joint axis from the recorded three-dimensional coordinate data of each body part, and the kinematic and kinetic parameters are calculated using the Plug-in Gait Matlab process.
Key secondary outcomes
Physical parameters related to the subject's physique, height, lower leg length, weight, BMI.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The drop board is set at the length of the individual's lower leg (lateral joint of the knee joint - lateral malleolus). From the edge of the set drop board, the athlete lands on the landing point set at a distance of 120% from the edge of the drop board in each direction: anterior (Anterior), antero-lateral (Antero-Lateral), and antero-medial (Antero-Medial).
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
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
A healthy woman aged 20-25.
A person with the ability to make their own decisions.
Key exclusion criteria
Those with neurological and orthopaedic disorders. Those with problems with motor function or cognitive function in the upper limbs, lower limbs or torso. Those with a history of lower limb surgery were excluded.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | Sawada |
Organization
Saitama Medical University
Division name
School of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0496
Address
981 Kawakad Moroyama-Machi Irumagun Saitama Japan
TEL
+81-49-295-1001
ysawada@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Sawada |
Organization
Saitama Medical University
Division name
School of Physical Therapy, Faculty of Health and Medical Care
Zip code
350-0496
Address
981 Kawakad Moroyama-Machi Irumagun Saitama Japan
TEL
+81-49-295-1001
Homepage URL
ysawada@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Faculty of Health and Medical Care
School of Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Faculty of Health and Medical Care
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
Ethical Committee of Saitama Medical
Address
38 Morohongo Moroyama-Machi Iruma-gun Saitama Japan
Tel
049-276-2143
rinri@saitama-med.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
| 2025 | Year | 02 | Month | 19 | 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
18
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 23 | 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
| 2025 | Year | 02 | Month | 19 | Day |
Last modified on
| 2025 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057871
