UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056028 |
|---|---|
| Receipt number | R000063969 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2024/11/03 |
| Last modified on | 2026/01/30 16:05:05 |
* 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
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
Acronym
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
Scientific Title
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
Scientific Title:Acronym
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
Region
| Japan |
Condition
Condition
frailty (including cancer, dementia, and so on)
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to identify clinical parameters for early detection of ADL decline by utilizing a novel sensor that detects minute vibrations associated with muscle stretching and contraction in patients who are living in nursing homes or receiving home visits with limited ADL. As a secondary step, the sensor data will be integrated and analyzed with multidimensional clinical information data such as vital signs, blood collection results, and intestinal microflora to serve as a stepping stone for a randomized controlled trial to test whether the sensor data will reduce emergency transports and unscheduled hospitalizations in the future.
Basic objectives2
Others
Basic objectives -Others
To explore and identify clinical parameters that can be utilized in the future
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection of parameters calculated from vibration sensor data that correlate with changes in Barthel Index and DASC-8 scores
Key secondary outcomes
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
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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).
Key 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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Natsumi |
| Middle name | |
| Last name | Niino |
Organization
Saitama Medical University Hospital
Division name
Department of palliative medicine
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1705
niino.natsumi@1972.saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuta |
| Middle name | |
| Last name | Hashimoto |
Organization
Saitama Medical University Hospital
Division name
Department of palliative medicine
Zip code
3500495
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama
TEL
049-276-1705
Homepage URL
palliative.saitamameduniv@gmail.com
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
SECOM Science and Technology Foundation
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
MoroActive Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University
Address
38, Morohongo, Moroyama-machi, Iruma-gun, Saitama
Tel
049-276-1662
chuoirb@saitama-med.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
山崎内科医院（岩手県）、鶴ヶ島在宅医療診療所（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 03 | 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
83
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 22 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 03 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Every 2 weeks, the patients' ADLs and vibration waveforms of the new sensor will be evaluated; every 4 weeks, grip strength, weight, and leg circumference will be measured; every 24 weeks, the patients' medications will be checked and blood tests and fecal collection will be carried out. These will be performed for 48 weeks.
Management information
Registered date
| 2024 | Year | 11 | Month | 03 | Day |
Last modified on
| 2026 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063969
