UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054490 |
|---|---|
| Receipt number | R000062236 |
| Scientific Title | Development and Clinical Application of a Gait Training Monitoring System |
| Date of disclosure of the study information | 2026/01/01 |
| Last modified on | 2025/12/30 03:41:43 |
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Basic information
Public title
Development and Clinical Application of a Therapist-Worn Gait Training Support System
Acronym
Development and Clinical Application of a Therapist-Worn Gait Training Support System
Scientific Title
Development and Clinical Application of a Gait Training Monitoring System
Scientific Title:Acronym
Development and Clinical Application of a Gait Training Monitoring System
Region
| Japan |
Condition
Condition
central nervous disease, bone and joint disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop a therapist-worn gait training support system and investigate its clinical efficacy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gait training information (step count, gait distance, gait speed, heart rate, etc.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wearable sensors capable of measuring gait training parameters were attached to the patient, and the acquired data were transmitted in real time to a therapist-worn device to support gait training.
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
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who are able to provide written informed consent to participate in the study of their own free will
2. Patients aged 20 years or older and younger than 90 years at the time of consent
3. Ability to participate in gait training
Key exclusion criteria
1. Presence of a cardiac pacemaker
2. Pregnancy
3. Disturbance of consciousness or cognitive impairment
4. Recurrence
5. Requirement for gait assistance
6. Use of medications that affect heart rate
7. Inability or refusal to provide informed consent
8. Patients deemed inappropriate for participation by the attending physician or principal investigator etc
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Sawada |
| Middle name | |
| Last name | Koshiro |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
reha@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Hishikawa |
| Middle name | |
| Last name | Norikazu |
Organization
Graduate School of Medical Science, Kyoto Prefectural University of Medicine
Division name
Department of Rehabilitation Medicine
Zip code
602-8566
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5324
Homepage URL
hisikawa@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
KYOCERA corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Prefectural University of Medicine
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan
Tel
rinri@koto.kpu-m.ac.jp
rinri@koto.kpu-m.ac.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
京都府立医科大学附属病院（京都府），京都学際研究所がくさい病院（京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 27 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062236
