UMIN-ICDS Clinical Trial

Public title

Immediate effects of a wearable gait-assist device after total knee arthroplasty

Acronym

Walk-Mate 3.0 TKA Study

Scientific Title

Immediate effects of a single session with the Walk-Mate 3.0 hip-worn gait-assist device on walking and stair ascent after total knee arthroplasty

Scientific Title:Acronym

Walk-Mate 3.0 TKA Immediate Effects Study

Region

Japan

Condition

Knee osteoarthritis after total knee arthroplasty

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the immediate effects of a single session with the Walk-Mate 3.0 hip-worn gait-assist device in patients experiencing difficulty with level walking or stair ascent after total knee arthroplasty (TKA). The primary objective is to compare comfortable walking speed between the assist-ON and assist-OFF conditions to evaluate the immediate effect of active assistance. Secondary objectives include evaluating gait parameters, stair ascent time, pain, fatigue, perceived ease of movement, device comfort, and safety.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Difference in comfortable walking speed (m/s) between the assist-ON and assist-OFF conditions during a single session with the Walk-Mate 3.0 device. Walking speed is calculated over the middle 10 m of a 20-m walking course using the mean of two trials per condition. The outcome is assessed during a single study visit.

Key secondary outcomes

Secondary outcomes include time required to ascend 15 stairs, step count, step length, cadence, gait cycle, gait symmetry, trunk sway, pain (NRS), perceived fatigue, ease of movement, device comfort, device malfunctions, and adverse events. Exploratory comparisons between the no-device and assist-OFF conditions and between the no-device and assist-ON conditions will also be performed. All outcomes will be assessed during a single study visit.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Participants first perform two 20-m walking trials and one 15-step stair ascent trial without the device. After donning the Walk-Mate 3.0 device, the assistance level is individually adjusted during practice walking to achieve a comfortable walking experience for each participant. The settings are then kept constant, and the same assessments are performed in the assist-OFF condition followed by the assist-ON condition. Adequate rest is provided between conditions. All assessments are completed during a single visit.

Interventions/Control_2

Participants first perform two 20-m walking trials and one 15-step stair ascent trial without the device. After donning the Walk-Mate 3.0 device, the assistance level is individually adjusted during practice walking to achieve a comfortable walking experience for each participant. The settings are then kept constant, and the same assessments are performed in the assist-ON condition followed by the assist-OFF condition. Adequate rest is provided between conditions. All assessments are completed during a single visit.

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients aged 20 years or older.
2) Patients who underwent primary total knee arthroplasty (TKA) for knee osteoarthritis and are currently receiving outpatient follow-up at our institution.
3) Patients reporting difficulty with level walking and/or stair ascent, regardless of severity.
4) Patients able to walk 20 m continuously without physical assistance, with or without a single-point cane.
5) Patients able to safely ascend and descend 15 stairs without physical assistance, with or without a single-point cane and handrail.
6) Patients without weight-bearing restrictions on the operated limb and with complete wound healing.
7) Patients able to understand the study and provide written informed consent.
8) Patients considered suitable for safe testing by the attending physician and study investigator.

No restrictions are imposed on the time since surgery or baseline walking speed.

Key exclusion criteria

1) Patients with a history of revision TKA or subsequent surgery on the lower limb to be evaluated.
2) Patients with postoperative complications affecting safety, including infection, fracture, deep vein thrombosis, pulmonary embolism, or wound problems.
3) Patients with severe pain, unstable cardiovascular or respiratory conditions, severe dizziness, or other conditions preventing safe walking.
4) Patients with neurological disorders, severe contralateral lower limb disorders, or other musculoskeletal conditions substantially affecting gait.
5) Patients requiring walking aids beyond a single-point cane, including walkers or bilateral crutches.
6) Patients unable to safely ascend and descend 15 stairs without physical assistance, even with a handrail.
7) Patients with cognitive impairment or other conditions preventing adequate understanding of the study, communication of consent, or compliance with instructions.
8) Patients unable to safely wear the device or sensors because of body size, orthoses, skin conditions, or other factors.
9) Patients considered inappropriate for participation by the attending physician or principal investigator for any other reason.

Target sample size

40

Name of lead principal investigator

1st name	Yusuke
Middle name
Last name	Nakagawa

Organization

Institute of Science Tokyo

Division name

Joint Surgery and Sports Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-4020

Email

ynakagawa.orj@tmd.ac.jp

Name of contact person

1st name	Yuta
Middle name
Last name	Shimizu

Organization

Institute of Science Tokyo

Division name

Joint Surgery and Sports Medicine

Zip code

113-8510

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-5803-4020

Homepage URL

Email

shimizu.y.e672@m.isct.ac.jp

Institute

Institute of Science Tokyo

Institute

Department

Personal name

Organization

Institute of Science Tokyo

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Bioethics Group, Research Infrastructure Division, Research Promotion Department

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

Tel

03-5803-4547

Email

rinri.adm@tmd.ac.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

11

Month

01

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

11

Month

01

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

16

Day

Last modified on

2026

Year

10

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072476