UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059986 |
|---|---|
| Receipt number | R000068598 |
| Scientific Title | Effect of a 3-Week Lateral Band Walk Intervention on Knee Valgus Angle During Single-Leg Drop Landing in Adult Females With Dynamic Knee Valgus: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 13:08:53 |
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Basic information
Public title
Evaluation of the Effect of a 3-Week Lateral Band Walk Intervention on Dynamic Knee Valgus in Adult Females
Acronym
LBW-DKV Study
Scientific Title
Effect of a 3-Week Lateral Band Walk Intervention on Knee Valgus Angle During Single-Leg Drop Landing in Adult Females With Dynamic Knee Valgus: A Randomized Controlled Trial
Scientific Title:Acronym
LBW-DKV RCT
Region
| Japan |
Condition
Condition
Dynamic Knee Valgus
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effect of a 3-week Lateral Band Walk intervention on knee valgus angle during single-leg drop landing in adult females with dynamic knee valgus.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Knee valgus angle during single-leg drop landing, measured at baseline and immediately after the 3-week intervention using 3D motion analysis.
Key secondary outcomes
Biomechanical variables of the knee and hip during single-leg drop landing and single-leg squat
Vertical ground reaction force (vGRF) normalized by body weight, and loading rate
Knee varus/valgus moment
Subjective evaluations of knee stability, confidence in movement, and body control
Indicators of ACL injury prevention awareness, adherence, and fidelity to the intervention (session counts, form evaluation, and interview records)
Knee valgus angle during single-leg drop landing at 2-week follow-up
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Participants will perform a home-based Lateral Band Walk exercise using a mini-band for 3 weeks. Each session will last approximately 10 minutes, with a target of at least 15 sessions during the intervention period. The exercise is performed by placing a mini-band around the thighs and walking laterally while maintaining slight knee flexion. Prior to the intervention, the researcher will provide in-person instruction on proper form, and weekly follow-up interviews and video submissions will be used to monitor adherence and exercise technique.
Interventions/Control_2
No-intervention control (usual activity group)
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
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
Healthy adult females who demonstrate relatively greater dynamic knee valgus during a screening single-leg squat assessment.
Key exclusion criteria
Individuals with a history of anterior cruciate ligament reconstruction
Those who do not meet the criteria in the screening assessment
Those who cannot safely perform a single-leg squat or single-leg drop landing due to pain, discomfort, or musculoskeletal disorders
Those who are judged to have difficulty maintaining participation throughout the study period
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Keiya |
| Middle name | |
| Last name | Serizawa |
Organization
Juntendo University, Graduate School
Division name
Graduate School of Health Science Doctoral Program
Zip code
113-0033
Address
Ochanomizu Center Building, 3-2-12 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
ghs8525002@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Keiya |
| Middle name | |
| Last name | Serizawa |
Organization
Juntendo University, Graduate School
Division name
Graduate School of Health Science Doctoral Program
Zip code
113-0033
Address
Ochanomizu Center Building, 3-2-12 Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-3111
Homepage URL
ghs8525002@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Keiya Serizawa
Funding Source
Organization
Juntendo University
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
Ethics Committee, Faculty of Health Science, Juntendo University
Address
Ochanomizu Center Building, 3-2-12 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
grad.hs@juntendo.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 | 12 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 30 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 05 | Day |
Last follow-up date
| 2028 | 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 | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068598
