UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053922 |
|---|---|
| Receipt number | R000061550 |
| Scientific Title | Impact of Digital Therapeutics (Dtx) on Locomotive Syndrome Using a Smartphone Application |
| Date of disclosure of the study information | 2024/03/22 |
| Last modified on | 2024/03/21 12:25:56 |
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Basic information
Public title
Impact of Digital Therapeutics (Dtx) on Locomotive Syndrome Using a Smartphone Application
Acronym
Impact of Digital Therapeutics (Dtx) on Locomotive Syndrome Using a Smartphone Application
Scientific Title
Impact of Digital Therapeutics (Dtx) on Locomotive Syndrome Using a Smartphone Application
Scientific Title:Acronym
Impact of Digital Therapeutics (Dtx) on Locomotive Syndrome Using a Smartphone Application
Region
| Japan |
Condition
Condition
Locomotive Syndrome
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In Japan, we are facing an aging society that is prominent in the world. Although locomotor disorders are recommended as a means of preventing and improving Locomotive syndrome (LS), it is difficult to encourage the elderly to change their exercise habits. In addition, the medical and human costs associated with the need for support and care due to LS are significant, and this is a serious social problem. In this study, if locomotor training can be made a habit using Dtx, and if locomotor training can be shown to maintain and improve exercise function through continued locomotor training, it will lead to an improvement in the healthy life expectancy of the elderly themselves. It is also important from a social perspective, as it will lead to reductions in medical costs and human burden.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Timed Up & Go (TUG) test
Key secondary outcomes
Number of locomotion training (LT) sessions
25-question geriatric locomotive function scale (GLFS-25)
Behavioral Regulation in Exercise Questionnaire-3 (BREQ-3)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Perform locomotive syndrome training (one leg stand, squat) once a day for 60 days
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients aged 40 years or older who visited the collaborating institutions and underwent a locomotive syndrome check (loco check: 1. cannot put on a sock with one leg, 2. stumble in the house, 3. need a handrail to go up stairs, 4. have difficulty using a vacuum cleaner at home, 5. have difficulty carrying home shopping weighing 2 kg or more, 6. have difficulty walking continuously for 15 minutes or more, 7. Difficulty walking continuously for more than 15 minutes, 7. Inability to cross a crosswalk with a green light), patients who fall into any of these categories are targeted as LS patients or LS premenopausal patients.
Patients with a Mini-Cog score of 3 or higher after prior assessment of cognitive function using the Mini-Cog.
(3) Patients who agree to participate in this study.
(4) Patients who are able to use the smartphone application
(5) Patients who have a history of regular visits to the collaborating institution.
Key exclusion criteria
(1) Patients who are unable to maintain their exercise routine due to serious medical conditions
(2) Patients whose exercise is restricted after surgical procedures
(3) Patients who have difficulty using smartphone applications due to cognitive decline
(4) Patients who have difficulty using smartphone applications due to visual or hearing impairment
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Matsumoto |
Organization
Fukushima medical university
Division name
Department of Orthopaedic Surgery
Zip code
9601295
Address
Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima-shi, Fukushima
TEL
0245471276
ymatsu@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuru |
| Middle name | |
| Last name | Sonobe |
Organization
Fukushima medical university
Division name
Department of Orthopaedic Surgery
Zip code
9601295
Address
Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima-shi, Fukushima
TEL
0245471276
Homepage URL
tatsuru1@fmu.ac.jp
Sponsor or person
Institute
Fukushima medical university
Institute
Department
Personal name
Funding Source
Organization
Fukushima medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fukushima medical university
Address
Fukushima Medical University School of Medicine, 1 Hikarigaoka, Fukushima-shi, Fukushima
Tel
0245471276
tatsuru1@fmu.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
| 2024 | Year | 03 | Month | 22 | 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
| 2024 | Year | 03 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061550
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