UMIN-ICDS Clinical Trial

Public title

Development of a lower limb asymmetry improvement device using vibration feedback for post-knee surgery patients.

Acronym

Vibration Feedback Device for Post-Knee Surgery

Scientific Title

Development of a system and device for improving asymmetry between involved and uninvolved limbs using multisensory feedback of muscle output timing.

Scientific Title:Acronym

Multisensory Feedback System for Inter-limb Asymmetry

Region

Japan

Condition

Anterior Cruciate Ligament (ACL) injury and motor dysfunction after knee surgery

Classification by specialty

Orthopedics	Rehabilitation medicine	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To promote the conscious awareness of correct bilateral muscle activity in patients by enabling them to perceive the left-right asymmetry in muscle activation timing. This is achieved using a wearable device that converts the difference in force onset timing between the involved and uninvolved limbs into a physical sensation of "simultaneous bilateral vibration."

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The difference in force onset timing (muscle output timing) between the involved and uninvolved limbs, calculated from lower leg acceleration.

Key secondary outcomes

Surface electromyography (EMG) of the vastus medialis, biceps femoris, and semitendinosus muscles, knee joint flexion angle, and responses to vibration feedback.

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Motion training (knee flexion/extension) using a device that calculates the difference in force onset timing between the involved and uninvolved limbs from lower leg acceleration, and presents vibration feedback to the involved limb with a temporal shift relative to the uninvolved limb.

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

Age-lower limit

18

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Individuals aged 18 to 65 years. [Healthy subjects] Individuals with no history of lower limb trauma or surgery, no current orthopedic or neurological complaints, and confirmed via interview to have no difficulty performing the test movements. [Patients] Post-knee surgery patients, including those with ACL reconstruction, who are currently undergoing rehabilitation at the collaborating hospital.

Key exclusion criteria

Individuals with uncontrolled heart failure, acute myocardial infarction, active myocarditis/pericarditis, unstable angina, acute systemic embolism/pulmonary embolism, or acute infection. Subjects will also be excluded if they exhibit abnormal symptoms during the test, such as moderate dyspnea, heart rate exceeding 140 bpm, or tachyarrhythmia.

Target sample size

36

Name of lead principal investigator

1st name	Hiroyasu
Middle name
Last name	Iwata

Organization

Waseda University

Division name

Faculty science and engineering

Zip code

162-0042

Address

Room 603, Green Computing Systems Research Organization, Building 40, Waseda University, 27 Waseda-cho, Shinjuku-ku, Tokyo

TEL

03-3203-4427

Email

jubi@waseda.jp

Name of contact person

1st name	Hiroyasu
Middle name
Last name	Iwata

Organization

Waseda University

Division name

Faculty science and engineering

Zip code

162-0042

Address

Room 603, Green Computing Systems Research Organization, Building 40, Waseda University, 27 Waseda-c

TEL

03-3203-4427

Homepage URL

Email

jubi@waseda.jp

Institute

Waseda University

Institute

Department

Personal name

Organization

Waseda University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Waseda University

Address

1-104 Totsuka-cho, Shinjyuku-ku, Tokyo 169-8050

Tel

03-5272-1639

Email

rinri@list.waseda.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

10

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

10

Month

14

Day

Date of IRB

Anticipated trial start date

2026

Year

11

Month

01

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

10

Month

10

Day

Last modified on

2026

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072382