UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061469 |
|---|---|
| Receipt number | R000069524 |
| Scientific Title | Evaluation of a Novel Airbag Hip Protector in Hospitalized and Institutionalized Older Adults: A Multicenter Prospective Single-arm Observational Study |
| Date of disclosure of the study information | 2026/05/07 |
| Last modified on | 2026/05/07 13:17:29 |
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Basic information
Public title
Evaluation of a Novel Airbag Hip Protector in Hospitalized and Institutionalized Older Adults: A Multicenter Prospective Single-arm Observational Study
Acronym
Evaluation of a Novel Airbag Hip Protector in Older Adults
Scientific Title
Evaluation of a Novel Airbag Hip Protector in Hospitalized and Institutionalized Older Adults: A Multicenter Prospective Single-arm Observational Study
Scientific Title:Acronym
Evaluation of a Novel Airbag Hip Protector in Older Adults
Region
| Japan |
Condition
Condition
Older adults with conditions qualifying them for admission to a convalescent rehabilitation ward who are currently hospitalized in a medical facility or admitted to a geriatric healthcare facility.
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hip fracture incidence per fall will be observed among older adults wearing a novel hip protector currently under development, and its safety, fit, and acceptability will be evaluated. In addition, real-world patterns of use, rehabilitation implementation, and physical function will be comprehensively documented in routine clinical settings to generate foundational data for practical deployment of the device and to inform future interventional studies.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of fall-related hip fractures during the observation period (number of hip fractures per cumulative number of falls)
Evaluation period: During the observation period (for hospitalized participants, from initiation of wear to discharge; for nursing home residents, from initiation of wear to 3 months. In addition, if consent is obtained, assessments will be continued throughout the 6-month post-discharge follow-up period).
Key secondary outcomes
Fall incidence (number of falls per unit time; number of falls per 100 patient-months at each study site)
Evaluation period: During the observation period (for hospitalized participants, from initiation of wear to discharge; for nursing home residents, from initiation of wear to 3 months. In addition, if consent is obtained, assessments will be continued throughout the 6-month post-discharge follow-up period).
Physical function assessments (grip strength, Hasegawa Dementia Scale, Timed Up and Go test)
Evaluation period: At initiation of wear; every 2 weeks during wear; at discharge (or 3 months after initiation of wear); and at outpatient follow-up visits after discharge.
Discomfort associated with wearing the hip protector
Evaluation period: At initiation of wear; 1 day after initiation; and 1 week after initiation.
Hip range of motion (hip flexion/extension, abduction/adduction, external/internal rotation angles)
Evaluation period: At initiation of wear; 1 day after initiation; and 1 week after initiation.
Skin condition (presence of contact dermatitis and abrasions related to wear)
Evaluation period: Daily throughout the wear period.
Opinion survey regarding the lumbar support device (comfort, ease of donning, etc., as rated by participants and staff)
Evaluation period: During the observation period (conducted as a field survey).
Airbag deployment status (deployment time, deployment timing, and participant impressions of deployment via open-ended questions)
Evaluation period: When airbag deployment occurs due to a fall or other trigger (recorded each time an event occurs).
IMU sensor data during falls (acceleration waveform, peak acceleration [impact magnitude], fall direction [changes in sensor axes])
Evaluation period: At the time of each fall.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Individuals aged 65 years or older at the time of consent acquisition
Individuals necessitating hospitalization and treatment for conditions warranting admission to recovery-phase rehabilitation wards, or individuals currently residing in nursing care health facilities with conditions warranting such admission
Individuals capable of providing written consent for participation in this study.
Key exclusion criteria
1 Individuals meeting the criteria for cessation of rehabilitation (when active rehabilitation is not to be conducted)
2 Individuals with a resting pulse rate below 40 beats per minute or above 120 beats per minute
3 Individuals with resting systolic blood pressure of 70 mmHg or lower or 200 mmHg or higher
4 Individuals with resting diastolic blood pressure of 120 mmHg or higher
5 Individuals with exertional angina pectoris
6 Individuals with atrial fibrillation accompanied by significant bradycardia or tachycardia
7 Individuals immediately post-myocardial infarction with poor circulatory dynamics
8 Individuals with severe arrhythmia
9 Individuals experiencing resting chest pain
10 Individuals presenting with palpitations, shortness of breath, or chest pain prior to the initiation of rehabilitation
11 Individuals experiencing symptoms such as dizziness, cold sweats, or nausea while seated
12 Individuals with a resting SpO2 below 90%
13 Individuals with impeding independent walking
14 Individuals with severe cognitive impairment impeding comprehension of instructions
15 Individuals with contact dermatitis, abrasions, or bedsores on their bodies
16 Individuals with skin diseases caused by contact infection
17 Individuals with lower limb deformities preventing the use of new hip protectors
18 Individuals with severe osteoporosis
19 Individuals utilizing implantable electronic devices such as cardiac pacemakers
20 Individuals with conflicts of interest with the principal investigator or co-investigators
21 Any other individuals deemed inappropriate by the principal investigator or co-investigators.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Mikami |
Organization
Hiroshima University Hospital
Division name
Department of Rehabilitation Medicine
Zip code
734-8551
Address
Kasumi 1-2-3, Minamiku, Hiroshima
TEL
082-257-5566
mikamiy@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Asaeda |
Organization
Hiroshima University Hospital
Division name
Division of Rehabilitation, Department of Clinical Support
Zip code
734-8551
Address
Kasumi 1-2-3, Minamiku, Hiroshima
TEL
082-257-5566
Homepage URL
asaedam@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daicel Corporation
Name of secondary funder(s)
Daicel Corporation
IRB Contact (For public release)
Organization
Hiroshima University
Address
Kasumi 1-2-3, Minamiku, Hiroshima
Tel
082-257-1551
iryo-sinsa@office.hiroshima-u.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 | 05 | Month | 07 | 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 | 26 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Novel Hip Protector Installation
Details: This airbag-type hip protector incorporates an IMU sensor positioned above the pelvis. Upon detecting a fall, it deploys in less than 0.1 seconds to protect the pelvic region. It should be worn continuously during hospitalization or institutional stay, except during toileting, changing clothes, and bathing.
Management information
Registered date
| 2026 | Year | 05 | Month | 07 | Day |
Last modified on
| 2026 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069524
