UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000058339
Receipt number R000066693
Scientific Title Clinical Evaluation of Gait Improvement Through Multisensory Plantar Pressure Feedback
Date of disclosure of the study information 2025/07/03
Last modified on 2025/07/02 00:43:01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Clinical Evaluation of Gait Improvement Through Multisensory Plantar Pressure Feedback

Acronym

Clinical Evaluation of Gait Improvement Through Multisensory Plantar Pressure Feedback

Scientific Title

Clinical Evaluation of Gait Improvement Through Multisensory Plantar Pressure Feedback

Scientific Title:Acronym

Clinical Evaluation of Gait Improvement Through Multisensory Plantar Pressure Feedback

Region

Japan


Condition

Condition

Stroke patients
Elderly patients
Post-orthopedic surgery patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To validate the effectiveness of a perceptual assistance device that provides multisensory feedback

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Lower extremity coordinates, force, gait data, blood pressure and heart rate, surface myoelectricity, acceleration, myoelectric potentials, ankle plane angle, video recording during test, vibration sensation
Evaluation period: Before, during and after the intervention.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Wearing a perception support device equipped with functions for measuring the center of foot pressure and load and for real-time FB of the values, the subject walks while perceiving his/her own center of foot pressure and load. It is also envisioned to use auditory and visual (VR, AR, display, etc.) aids.

Interventions/Control_2

Perform normal walking

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who have been diagnosed with knee osteoarthritis and who wish to participate in training using sensory-assistive orthoses.

Hemiplegic patients who request to participate in training with sensory supportive orthosis and meet the following criteria:
1. Patients with lower limb Brunnstrom stage III to VI
2. Patients with no higher brain dysfunction
3. Patients whose attending physicians and physical therapists can judge that there is no problem in performing the examination.

Able-bodied elderly patients who have requested to participate in training using sensory supportive orthosis.

Key exclusion criteria

1. uncontrolled heart failure
2. acute myocardial infarction
3. active myocarditis or pericarditis
4. unstable angina
5. acute systemic embolism or pulmonary embolism
6. acute infection
7. thrombophlebitis
8. ventricular tachycardia or refractory ventricular arrhythmia
9. severe ventricular outflow tract obstruction
10. uncontrolled arterial or pulmonary hypertension 10. Uncontrolled arterial or pulmonary hypertension
11. Contemporaneous inclusion in another interventional study (verbally check with your physiotherapist)

Target sample size

80


Research contact person

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

27 Waseda-cyomachi, Shinjuku-ku, Tokyo, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.

TEL

03-3203-4427

Email

jubi@waseda.jp


Public contact

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

27 Waseda-cyomachi, Shinjuku-ku, Tokyo, Japan Green Computing Systems Reserch Organization 603

TEL

03-3203-4427

Homepage URL


Email

jubi@waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda University

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

Wasada University ethics review committee

Address

The 9th Building, 2nd Floor, 1-104 Totsuka-machi, Shinjuku-ku, Tokyo

Tel

03-5272-1639

Email

rinri@list.waseda.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

苑田会リハビリテーション病院、横浜石心会病院


Other administrative information

Date of disclosure of the study information

2025 Year 07 Month 03 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

2025 Year 07 Month 03 Day

Date of IRB


Anticipated trial start date

2025 Year 08 Month 01 Day

Last follow-up date

2030 Year 03 Month 30 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 07 Month 02 Day

Last modified on

2025 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066693