UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060679 |
|---|---|
| Receipt number | R000069386 |
| Scientific Title | Changes in movement with a hip extension assistive robotic orthosis |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/16 10:38:53 |
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Basic information
Public title
Changes in movement with a hip assist robotic orthosis
Acronym
Changes in movement with a hip-assist robot
Scientific Title
Changes in movement with a hip extension assistive robotic orthosis
Scientific Title:Acronym
Changes in movement with a hip-assist robot
Region
| Japan |
Condition
Condition
Cerebrovascular disease, bone and joint disease, spinal disease
Classification by specialty
| Neurology | Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore changes in movement with robotic orthosis by gait analysis
Basic objectives2
Others
Basic objectives -Others
To investigate changes in gait pattern with a hip extension robotic orthosis
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hip extension angle
Key secondary outcomes
cadence, walking speed, and walking pattern indicators (joint angles, center of gravity trajectory, and temporal-distance factors)
Walking ease with a robotic orthosis (Numerical Rating Scale)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Subjects walk on the ground and on a treadmill in 5 conditions as follows: 1 without robotic orthosis, 2 robotic orthosis with power off, 3 robotic orthosis with low intensity, 4 robotic orthosis with high intensity, and 5 without robotic orthosis again. The 2-4 are performed in random order.
On the ground, subjects walk 8 meters twice at a comfortable walking speed. On the treadmill, subjects walk at a comfortable walking speed for 30 seconds.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are able to walk on the ground and treadmill under supervision or independently, or with the use of suspension devices.
Key exclusion criteria
Patients with severe cognitive impairment, who require restrictions on exercise due to internal disease, and who have pain with robotic orthoses
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
hkagaya2@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Hitoshi |
| Middle name | |
| Last name | Kagaya |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Rehabilitation Medicine
Zip code
474-8511
Address
7-430 Morioka-cho, Obu, Aichi
TEL
0562-46-2311
Homepage URL
hkagaya2@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
INOMER inc.
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
National Center for Geriatrics and Gerontology
Address
7-430 Morioka-cho, Obu, Aichi
Tel
0562-46-2311
yaday@ncgg.go.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
国立長寿医療研究センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 16 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Last modified on
| 2026 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069386
