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Jan. 22, 2020

July. 01, 2025

jRCTs042190109

Validity of the abnormal gait evaluation for stroke patients using the welwalk WW-2000S (VAGEWW)

Abnormal gait evaluation using the welwalk WW-2000S (AGEWW)

Mar. 04, 2025

34

Healthy adults: age 16 or over, height between 140cm and 190cm, weight between 40kg and 95kg. Cerebrovascular disease patients: age 16 or over, height between 140cm and 190cm, weight between 40kg and 95kg, who are able to walk using the Welwalk with supervision or independently.

Seventeen healthy adults and 17 individuals with cerebrovascular disorders were included in this study.

As a safety analysis, we counted the number of adverse events that could not deny a causal relationship with the gait training using the Welwalk WW-2000S, and the number of malfunctions with the Welwalk WW-2000S. As a result, there were no adverse events, and there were no malfunctions with the Welwalk WW-2000S.

As for the primary outcome, the abnormal gait pattern index values calculated using the three-dimensional motion analysis system and the Welwalk WW-2000S gait analysis system were shown to have moderate to very high correlations in experiments using simulated walking by healthy adults. The results of experiments on patients also showed the same trend as the results of experiments on healthy adults. As a secondary outcome, there was a high correlation between the scores of the observational assessment for abnormal gait patterns and the abnormal gait pattern index values calculated by the Welwalk WW-2000S gait analysis system in the experiment using simulated walking by healthy people. Furthermore, the Welwalk WW-2000S gait analysis system showed high sensitivity and specificity to detect abnormal gait patterns that could lead to falls in the simulated walking by healthy adults.

The purpose of this study was to assess the validity for the abnormal gait pattern index values calculated by the Welwalk WW-2000S gait analysis system. We confirmed that there was a high correlation between the results of the index values calculated by the Welwalk WW-2000S gait analysis system and the results of index values calculated by the three-dimensional motion analysis system or the scores by observational assessment.

July. 01, 2025

Yes

If the joint research facility, Toyota Motor Corporation, asks us to provide the results of the study, we will provide the anonymized information of the participants and not the corresponding tables.

https://jrct.mhlw.go.jp/latest-detail/jRCTs042190109

Otaka Yohei

Fujita Health University Hospital

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

+81-562-93-2167

rehabmed@fujita-hu.ac.jp

Hirano Satoshi

Fujita Health University Hospital

1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi 470-1192, Japan

+81-562-93-2167

sshirano@fujita-hu.ac.jp

Complete

Jan. 22, 2020

60

Interventional

non-randomized controlled trial

open(masking not used)

active control

parallel assignment

screening

Healthy and patient with a cerbulovascular disease

Unstable vital sign

16age old over
No limit

Both

Cerbulovascular disease

Healthy: walking simulating the abnormal gait pattern
Patient with a cerbulovascular disease: gait training using the Welwalk WW-2000S

The index value of abnormal gait pattern

Sensitivity, specificity, time factor for gait cycle

TOYOTA MOTOR CORPORATION
Not applicable
Fujita Health University Certified Clinical Research Review Board
1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Japan, Aichi

+81-562-93-2865

crb-f@fujita-hu.ac.jp
Approval

May. 21, 2020

none

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