UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059999 |
|---|---|
| Receipt number | R000068616 |
| Scientific Title | Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction |
| Date of disclosure of the study information | 2025/12/05 |
| Last modified on | 2025/12/05 16:10:28 |
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Basic information
Public title
Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction
Acronym
Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction
Scientific Title
Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction
Scientific Title:Acronym
Development and Clinical Evaluation of a Gluteus Medius Assistive Device for Abnormal Gait Correction
Region
| Japan |
Condition
Condition
-Knee osteoarthritis
-Trendelenburg gait
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the Gait-Correction Effect of an Assistive Motion Device
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
- Lateral knee acceleration
- Gait data
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants will walk for 10 minutes at a unified walking cadence of 100 bpm while wearing the device. The examiner will give the start and stop instructions, and lateral knee acceleration, pelvic frontal plane inclination angle, and other gait data will be continuously recorded during walking. The assistive mechanism of the device will operate in the normal support mode, and the intervention will be conducted while ensuring safety at all times.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Individuals who request to participate in training using the motion-assist orthosis, have been diagnosed with an abnormal gait, require the use of a corrective orthosis, and are deemed eligible for participation by both the attending physician and the physical therapist.
- Healthy older adults who request to participate in training using the motion-assist orthosis.
Key exclusion criteria
1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic embolism or pulmonary embolism
6. Acute infectious disease
7. Thrombophlebitis
8. Ventricular tachycardia or refractory ventricular arrhythmia
9. Severe left ventricular outflow tract obstruction
10. Uncontrolled arterial hypertension or pulmonary hypertension
11. Participation in another interventional study during the same period (to be verbally confirmed with the responsible physical therapist)
* The exclusion criteria will be determined by the attending physician.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
27 Waseda-machi, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 Prof. Iwata Lab.
TEL
03-3203-4427
jubi@waseda.jp
Public contact
Name of contact person
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Iwata |
Organization
Waseda University
Division name
Faculty science and engineering
Zip code
162-0042
Address
27 Waseda-machi, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603
TEL
03-3203-4427
Homepage URL
jubi@waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Yokohama Seishinkai Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Waseda University Institutional Review Board
Address
2nd Floor, Building 9, 1-104 Totsuka-machi, Shinjuku-ku, Tokyo
Tel
03-5272-1639
rinri@list.waseda.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
横浜石心会病院(神奈川県)
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 05 | 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
| 2025 | Year | 12 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 12 | Month | 05 | Day |
Last modified on
| 2025 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068616
