UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055680 |
|---|---|
| Receipt number | R000063623 |
| Scientific Title | Development and Clinical Evaluation of a Motion Assistance Device for the Prevention of Bowlegs |
| Date of disclosure of the study information | 2024/10/01 |
| Last modified on | 2024/09/30 18:49:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Development and Clinical Evaluation of a Motion Assistance Device for the Prevention of Bowlegs
Acronym
Development and Clinical Evaluation of a Motion Assistance Device for the Prevention of Bowlegs
Scientific Title
Development and Clinical Evaluation of a Motion Assistance Device for the Prevention of Bowlegs
Scientific Title:Acronym
Development and Clinical Evaluation of a Motion Assistance Device for the Prevention of Bowlegs
Region
| Japan |
Condition
Condition
knee osteoarthritis
Classification by specialty
| Orthopedics | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of the effectiveness of the developed system
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
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
Wear the device and walk for 10 minutes
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients with osteoarthritis of the knee
(ii) Post-operative osteoarthritis patients who can walk normally without the assistance of a third party
(iii) Healthy elderly people
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 infection
7. Thrombophlebitis
8. Ventricular tachycardia or refractory ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
10. Uncontrolled arterial or pulmonary hypertension
11. Those who are not capable of performing the tasks indicated in the test procedure (including breaks between tasks)
12. If the patient is in another intervention study at the same time (verbally confirmed with the physiotherapist in charge)
*Exclusion criteria are made at the discretion of the physician in charge
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 Ethics Review Committee
Address
Bldg. 9, 2F, 1-104 Totsukacho, 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
| 2024 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | 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
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063623
