Prospective study in community medicine to identify clinical parameters to predict risks of condition worsening and ADL decline detected by a new sensor for minute muscular shaking

Prospective study in community medicine to identify clinical parameters to predict risks of condition worsening and ADL decline detected by a new sensor for minute muscular shaking - Prospective study in community medicine to identify clinical parameters to predict risks of condition worsening and ADL decline detected by a new sensor for minute muscular shaking

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000056028

Enrollment

100

Registered

2024-11-03

Start date

2024-11-03

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

frailty (including cancer, dementia, and so on)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients requiring nursing care 3 or 4, nursing home residents or home-visit patients 2) Patients who have obtained written consent to participate in the research from themselves or their surrogate(s).

Exclusion criteria

Exclusion criteria: 1) Patients requiring nursing care 5 2) Patients with motor neuron disease and myasthenia gravis 3) Patients unable to follow instructions required for sensor data collection due to severe cognitive impairment, impaired consciousness, or other 4) Patients with paralysis in both lower limbs due to cerebrovascular disease, sequelae of trauma, etc. If the disability is unilateral, sensor waveform collection shall be performed on the healthy side and included in this study. 5) Patients whose prognosis is expected to be within 1 month 6) Patients who are deemed inappropriate for inclusion in this study by the principal investigator or investigator

Design outcomes

Primary

Measure	Time frame
Detection of parameters calculated from vibration sensor data that correlate with changes in Barthel Index and DASC-8 scores	—

Secondary

Measure	Time frame
1) Identification of clinical information including the sensor data parameters that contribute to the construction of a discrimination model for emergency transportation 2) Correlation of the sensor data parameters with relative leg muscle strength and leg circumference 3) Correlation of the sensor data parameters with grip strength and body weight 4) Correlation of the sensor data parameters between the group with decreased ADL score and the group with maintained ADL score 5) Relationship between changes in the sensor data parameters and ADL score decline over time 6) Association between changes in the sensor data parameters and emergency transportation 7) Association between changes in sensor data parameters and unscheduled hospitalization 8) Association between changes in the sensor data parameters and emergency re-transport within 90 days 9) Association between changes in the sensor data parameters and death 10) Association between inflammatory cytokines and decline in ADL score 11) Association between changes in sensor data parameters and disease 12) Association between changes in sensor data parameters and results of blood collection 13) Association between ADL score and leg circumference 14) Association between ADL scores and results of blood collection 15) Association between intestinal microbiota and ADL score changes	—

Measure

Time frame

1) Identification of clinical information including the sensor data parameters that contribute to the construction of a discrimination model for emergency transportation 2) Correlation of the sensor data parameters with relative leg muscle strength and leg circumference 3) Correlation of the sensor data parameters with grip strength and body weight 4) Correlation of the sensor data parameters between the group with decreased ADL score and the group with maintained ADL score 5) Relationship between changes in the sensor data parameters and ADL score decline over time 6) Association between changes in the sensor data parameters and emergency transportation 7) Association between changes in sensor data parameters and unscheduled hospitalization 8) Association between changes in the sensor data parameters and emergency re-transport within 90 days 9) Association between changes in the sensor data parameters and death 10) Association between inflammatory cytokines and decline in ADL score 11) Association between changes in sensor data parameters and disease 12) Association between changes in sensor data parameters and results of blood collection 13) Association between ADL score and leg circumference 14) Association between ADL scores and results of blood collection 15) Association between intestinal microbiota and ADL score changes

—

Countries

Japan

Contacts

Public ContactYuta Hashimoto

Saitama Medical University Hospital Department of palliative medicine

palliative.saitamameduniv@gmail.com049-276-1705

Outcome results