Tokyo, May 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061469) titled 'Evaluation of a Novel Airbag Hip Protector in Hospitalized and Institutionalized Older Adults: A Multicenter Prospective Single-arm Observational Study' on May 7.
Study Type:
Observational
Primary Sponsor:
Institute - Hiroshima University
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 malignancy - Others
Genomic information - NO
Objective:
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
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 Size - 500
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069524
Disclaimer: Curated by HT Syndication.
