UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043841 |
|---|---|
| Receipt number | R000050037 |
| Scientific Title | Exercise system using wearable sensors in rehabilitation |
| Date of disclosure of the study information | 2021/04/05 |
| Last modified on | 2022/10/06 10:25:36 |
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Basic information
Public title
Exercise system using wearable sensors in rehabilitation
Acronym
Exercise system using wearable sensors
Scientific Title
Exercise system using wearable sensors in rehabilitation
Scientific Title:Acronym
Exercise system using wearable sensors
Region
| Japan |
Condition
Condition
Healthy person, person who is in the rehabilitation department of our hospital or outpatient
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop an exercise system that provides appropriate practice plans and feedback by utilizing the visualization of the subject's movement state and objective data accumulation with wearable sensors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motion analysis obtained from joint angles measured by wearable sensors
Key secondary outcomes
Number of exercises, basic information, function / ability evaluation that is usually performed in clinical practice, 3D motion analysis using another device,Usability evaluation
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Measure physical activity with wearable sensors
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients using lower extremity orthosis that can walk independently
Key exclusion criteria
Those who are in an unstable general condition, those who cannot exercise voluntarily due to impaired consciousness, those who do not receive instructions from a therapist
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | YOHEI |
| Middle name | |
| Last name | OTAKA |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I school of Medicine
Zip code
4701192
Address
1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Hirano |
Organization
Fujita Health University Hospital
Division name
Department of Rehabilitation
Zip code
470-1192
Address
1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
TEL
0652-93-2155
Homepage URL
a-hirano@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
1-98 Dengakugakubo,Kutsukake,Toyoake,Aichi,Japan
Tel
0652-93-2167
rehabmed@fujita-hu.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
| 2021 | Year | 04 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 04 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 10 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2026 | 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
| 2021 | Year | 04 | Month | 05 | Day |
Last modified on
| 2022 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050037
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
