UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000062306 |
|---|---|
| Receipt number | R000068521 |
| Scientific Title | Development of a personalized assist system for gait rehabilitation robots to restore lower-limb propulsion |
| Date of disclosure of the study information | 2026/07/23 |
| Last modified on | 2026/07/22 17:11:55 |
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Basic information
Public title
Development of a personalized assist system for gait rehabilitation robots to restore lower-limb propulsion
Acronym
Development of a personalized assist system for gait rehabilitation robots
Scientific Title
Development of a personalized assist system for gait rehabilitation robots to restore lower-limb propulsion
Scientific Title:Acronym
Development of a personalized assist system for gait rehabilitation robots
Region
| Japan |
Condition
Condition
Stroke patients with hemiparesis
Cancer-related gait impairment
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Development of a personalized assist system for gait rehabilitation robots to restore lower-limb propulsion
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in lower-limb propulsion during gait following robot-assisted gait training
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
First, 15 sessions of robot-assisted gait training using a hip robot are conducted, and subsequently, 15 sessions of robot-assisted gait training using an ankle robot are conducted.
Interventions/Control_2
First, 15 sessions of robot-assisted gait training using an ankle robot are conducted, and subsequently, 15 sessions of robot-assisted gait training using a hip robot are conducted.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals capable of indoor ambulation using walking aids or orthoses, or those capable of independent walking.
Key exclusion criteria
Individuals with musculoskeletal conditions that may influence gait performance.
Individuals with gait impairments attributable to neuromuscular diseases unrelated to cancer treatment or to the primary cause of hemiparesis.
Individuals unable to comprehend testing instructions due to aphasia, dementia, or other cognitive or communication disorders.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Meguru |
| Middle name | |
| Last name | Taguchi |
Organization
Kansai Medical University
Division name
Physical Medicine of Rehabilitation
Zip code
573-1191
Address
5-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL
+81-72-804-0101
taguchi.meg@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Meguru |
| Middle name | |
| Last name | Taguchi |
Organization
Kansai Medical University
Division name
Physical Medicine of Rehabilitation
Zip code
573-1191
Address
5-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL
+81-72-804-0101
Homepage URL
taguchi.meg@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committees of the Kansai Medical University hospital
Address
5-1 Shinmachi 2 Chome, Hirakata City, Osaka
Tel
+81-72-804-0101
rinriirb@hirakata.kmu.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 23 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2035 | Year | 01 | 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
| 2026 | Year | 07 | Month | 22 | Day |
Last modified on
| 2026 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068521
