UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000061977
Receipt number R000070919
Scientific Title Effects of Running Speed and Foot Strike Pattern on Anterior Cruciate Ligament Loading: A Cross-Sectional Study Using Three-Dimensional Motion Analysis
Date of disclosure of the study information 2026/06/19
Last modified on 2026/06/19 15:08:00

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Basic information

Public title

Effects of running speed and foot strike pattern on knee ligament loading

Acronym

Run-ACL study

Scientific Title

Effects of Running Speed and Foot Strike Pattern on Anterior Cruciate Ligament Loading: A Cross-Sectional Study Using Three-Dimensional Motion Analysis

Scientific Title:Acronym

RSFS-ACL Study

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate the effects of different running speeds and foot strike patterns (rearfoot strike, midfoot strike, and forefoot strike) on lower-extremity biomechanical variables associated with anterior cruciate ligament (ACL) loading in healthy adults.

Running biomechanics will be assessed using a three-dimensional motion analysis system and force plates. Biomechanical variables, including knee joint angles, joint moments, and ground reaction forces, will be calculated. By comparing these variables across different running speeds and foot strike patterns, this study aims to identify mechanical characteristics associated with ACL injury risk and to provide evidence that may contribute to the prevention of primary ACL injuries and secondary ACL reinjuries.

Basic objectives2

Others

Basic objectives -Others

To investigate the effects of different combinations of running speeds and foot strike patterns on lower-extremity kinematic and kinetic variables, including those of the hip, knee, and ankle joints, and to comprehensively evaluate biomechanical characteristics associated with ACL loading.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Primary Outcome Measures

Peak vertical ground reaction force
Peak knee extension moment
Knee flexion angle
Knee valgus moment
Knee valgus angle
Hip adduction angle

These variables will be measured using a three-dimensional motion analysis system and force plates during running and will be compared across different running speeds and foot strike patterns.

Key secondary outcomes

Peak vertical ground reaction force
Knee flexion angle
Knee valgus moment
Knee valgus angle
Hip adduction angle
These variables will be measured using a three-dimensional motion analysis system and force plates during running and will be compared across different running speeds and foot strike patterns.


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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants will perform running trials under different running speed conditions (2.5 m/s, 3.5 m/s, and 4.5 m/s) and foot strike pattern conditions (rearfoot strike, midfoot strike, and forefoot strike) in a laboratory equipped with a three-dimensional motion capture system and force plates. Running biomechanics will be assessed using a motion capture system, force plates, and photocells. Lower-extremity kinematic and kinetic data will be collected during running. Outcome measures will include peak vertical ground reaction force, peak knee extension moment, knee flexion angle, knee valgus moment, knee valgus angle, and hip adduction angle. These variables will be compared across running speed and foot strike conditions.

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

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Healthy adults with no history of lower-extremity surgery and no current lower-extremity pain, injury, functional impairment, or physical condition that may affect running performance at the time of testing.

Key exclusion criteria

History of neurological or orthopedic disorders.
Any medical condition that may affect running biomechanics or performance.
Physical illness or poor health condition on the day of testing.
Inability to perform the instructed foot strike patterns during the running trials.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Tomoya
Middle name
Last name Takabayashi

Organization

Niigata University of Health and Welfare

Division name

Department of Physical Therapy, School of Rehabilitation Sciences

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan

TEL

025-257-4455

Email

takabayashi@nuhw.ac.jp


Public contact

Name of contact person

1st name Tomoya
Middle name
Last name Takabayashi

Organization

Niigata University of Health and Welfare

Division name

Department of Physical Therapy, School of Rehabilitation Sciences

Zip code

950-3198

Address

1398 Shimami-cho, Kita-ku, Niigata City, Niigata, Japan

TEL

025-257-4455

Homepage URL


Email

takabayashi@nuhw.ac.jp


Sponsor or person

Institute

Niigata University of Health and Welfare

Institute

Department

Personal name



Funding Source

Organization

nothing

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, Japan

Tel

025-257-4455

Email

takabayashi@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

2026 Year 06 Month 19 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

2026 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2026 Year 08 Month 01 Day

Last follow-up date

2030 Year 09 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 06 Month 19 Day

Last modified on

2026 Year 06 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070919