UMIN-CTR Clinical Trial

Public title

Developed shoes that enhance gait parameters without increasing muscle activity

Acronym

Development of shoes that are less muscle fatigue

Scientific Title

A pilot study on developed shoes that enhance gait parameters without increasing muscle activity

Scientific Title:Acronym

Development of shoes that improve gait parameters without increasing muscle activity

Region

Japan

Condition

healthy adults

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Innovative shoe development can significantly improve the gait performance of individuals and improve their overall quality of life. Therefore, this pilot study aimed to develop shoes with a rocker function but with a stable support base surface; however, the number of subjects was limited due to the inability to create multiple shoe sizes. Furthermore, this study aimed to compare the spatial and temporal characteristics and muscle activities of the lower limb while walking in shoes developed for healthy subjects compared to those in general shoes. We expect to develop more advanced and effective shoe designs that help elderly people improve their performance in activities of daily living and quality of life.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The spatiotemporal gait data :walking speed (m/s), cadence (steps/min), step length (cm), stride length (cm), stance time (s), swing time (s), single-stance time (s) and double-stance time (s)
Muscle activities(EMG): The bellies of the right anterior tibialis muscle (TA), the right gastrocnemius medialis (GM), and the right gastrocnemius lateralis (GL)

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

Participants were randomly assigned to two sequences of different shoes. In sequence 1, participants wore the developed shoes first; in sequence 2, participants wore the common shoes first.
INTERVENTION: The developed shoes have structural and form characteristics. (The most important structural feature of the developed shoes was the use of high elastic synthetic resin foam in the midsole.) This absorbs the shock when the heel touches the ground and generates resilience, thereby facilitating load transfer to the forefoot. In terms of shape, the developed shoes have two characteristics. First, the heel is longer toward the back and V-shaped. The purpose of this shape is to increase stability from heel contact to mid-stance and to promote heel contact and smooth forward transfer of pressure center with a wide supporting base surface. The toe spring angle is increased to enhance the propulsion of the forward movement of the center of gravity from mid-stance to heel-off.

Interventions/Control_2

Control: RAKUWALK, a commercial shoe brand, was used as the general shoe.

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

Female

Key inclusion criteria

healthy adult women
No cardiovascular, neurological, or musculoskeletal diseases

Key exclusion criteria

The exclusion criteria were as follows: individuals with foot pain within the previous 6 months, those with previous foot surgery, those with congenital or acquired foot deformities, and those with any other disabilities that affect gait.

Target sample size

10

Name of lead principal investigator

1st name	Teppei
Middle name
Last name	Abiko

Organization

Kyoto Tachibana University

Division name

Faculty of Health Sciences

Zip code

607-8175

Address

34 Yamada-cho Oyake, Yamashina-ku, Kyoto, Kyoto

TEL

075-571-1111

Email

abiko@tachibana-u.ac.jp

Name of contact person

1st name	Teppei
Middle name
Last name	Abiko

Organization

Kyoto Tachibana University

Division name

Faculty of Health Sciences

Zip code

607-8175

Address

34 Yamada-cho Oyake, Yamashina-ku, Kyoto, Kyoto

TEL

075-571-1111

Homepage URL

Email

abiko@tachibana-u.ac.jp

Institute

Kyoto Tachibana University

Institute

Department

Personal name

Teppei Abiko

Organization

Kyoto Tachibana University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

no

Address

no

Tel

no

Email

no

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

2024

Year

04

Month

26

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

10

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

Completed

Date of protocol fixation

2021

Year

06

Month

01

Day

Date of IRB

2021

Year

08

Month

02

Day

Anticipated trial start date

2021

Year

09

Month

01

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

04

Month

25

Day

Last modified on

2024

Year

04

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061964