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.
Conditions
Interventions
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 pe
Sponsors
Hiroshima University
Daicel Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactMakoto Asaeda
Hiroshima University Hospital Division of Rehabilitation, Department of Clinical Support
Outcome results
None listed