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Development of self-directed smart healthcare system for people with amputation and paralysis

Status Approved

First Submitted Date

2020/06/26
Registered Date

2020/06/30
Last Updated Date

2020/06/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005183
Unique Protocol ID	KCIRB-2020-0003-002
Public/Brief Title	Development of self-directed smart healthcare system for people with amputation and paralysis
Scientific Title	Development of self-directed smart healthcare system for people with amputation and paralysis
Acronym	self-directed smart healthcare
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KCIRB-2020-0003-002
Approval Date	2020-05-22
Institutional Review Board Name	Incheon Hospital Institutional Review Board
Institutional Review Board Address	446 Munemi-ro, Bupyeong-gu, Incheon
Institutional Review Board Telephone	032-500-0636
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Namsoon Cho
Title	MD, PhD.
Telephone	+82-32-500-0639
Affiliation	Korea worker's compensation & welfare service, Incheon hospital
Address	446, Munemi-ro, Bupyeong-gu, Incheon
Contact Person for Public Queries
Name	Jinhong Kim
Title	PT, PhD.
Telephone	+82-32-500-0639
Affiliation	Korea worker's compensation & welfare service, Incheon hospital
Address	446, Munemi-ro, Bupyeong-gu, Incheon
Contact Person for Updating Information
Name	Jinhong Kim
Title	PT, PhD.
Telephone	+82-32-500-0639
Affiliation	Korea worker's compensation & welfare service, Incheon hospital
Address	446, Munemi-ro, Bupyeong-gu, Incheon

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Recruiting
Date of First Enrollment	2020-06-10 Actual
Target Number of Participant	30
Primary Completion Date	2020-10-31 , Anticipated
Study Completion Date	2020-12-31 , Anticipated
Name of Study	Korea worker's compensation & welfare service, Incheon hospital
Recruitment Status	Recruiting
Date of First Enrollment	2020-06-10 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Science and ICT
Organization Type	Government
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Korea worker's compensation & welfare service, Incheon hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	With the recent development of IT technology, it combines IT technologies such as the Internet in the field of health care services, and provides health-related information, services, products, etc. to consumers by using smart devices that combine electronic technologies online and understands the health status of consumers. -The interest in the health industry is increasing, but there are insufficient devices, specialized software, and rehabilitation content for the health care of people with disabilities. In addition, using ICT technology at home and abroad, the doctor selects appropriate rehabilitation exercise contents for the patient's condition and provides them directly to the patient, and the patient interactively participates in the contents provided by the doctor periodically to match his current condition. No system provided to perform as. So, by developing products, software, and platforms for people with disabilities who are vulnerable to chronic diseases, they aim to promote health and prevent chronic diseases.

Study Summary Information

Lay Summary

With the recent development of IT technology, it combines IT technologies such as the Internet in the field of health care services, and provides health-related information, services, products, etc. to consumers by using smart devices that combine electronic technologies online and understands the health status of consumers. -The interest in the health industry is increasing, but there are insufficient devices, specialized software, and rehabilitation content for the health care of people with disabilities. In addition, using ICT technology at home and abroad, the doctor selects appropriate rehabilitation exercise contents for the patient&#39;s condition and provides them directly to the patient, and the patient interactively participates in the contents provided by the doctor periodically to match his current condition. No system provided to perform as. So, by developing products, software, and platforms for people with disabilities who are vulnerable to chronic diseases, they aim to promote health and prevent chronic diseases.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Non-RCT
Intervention Type	Behavioral
Intervention Description	Provide self-customized exercise contents using information and communication technology Wearable device, mobile phone (app installation)-Provides exercise content to check and manage patient general health data (PGHD) interactively (doctor, patient). Content of exercise content provided by the app. 1) Composition by type of failure -Paralysis: Paralysis (using a wheelchair) -Amputation: Femoral amputation, Lower femur amputation 2) Composition by exercise difficulty -1st level (easy), 2nd level (medium), 3rd level (difficult) 3) Type of exercise: classified as aerobic exercise, strength exercise, flexibility exercise. 4) Details Composed of 8 types of femoral cut (1~3 steps) (preparatory exercise/flexible exercise/strengthening exercise/body stabilization exercise/balance exercise/finishing exercise) Lower leg cutting (1~3 steps) consists of 8 types of exercise (preparatory exercise/flexibility exercise/strengthening exercise/body stabilization exercise/balance exercise/finishing exercise) Lower limb paralysis (1~3 steps) consists of 8 types of exercise (preparatory exercise/flexibility exercise/strength exercise/functional exercise/finishing exercise)
Number of Arms	1
Arm 1	Arm Label Amputation group (above knee, below knee), Paralysis, Lower Extremities
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Provide self-customized exercise contents using information and communication technology Prescribed anaerobic exercise 3 times a week for 12 weeks, aerobic exercise 2 days.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (Z00-Z99)Factors influencing health status and contact with health services (Z89.5)Acquired absence of leg at or below knee 1) Amputation, Traumatic 2) Paralysis, Lower Extremities
Rare Disease	No
Inclusion Criteria	Gender Both
	Age No Limit~No Limit
	Description (A) Those who have no abnormalities in cognitive function 『Mini-Mental State Examination (MMSE-K) 24 points or more』 (B) Patients with benign paralysis due to lesions of the central nervous system or peripheral nervous system (C) Patients with unilateral lower extremity amputation, except under ankle amputation. (D) A person who has passed 1 year or more after the onset
Exclusion Criteria	(A) A person with a combination of stroke and traumatic brain injury and amputation of the lower extremity. (B) Persons who have had surgery due to nervous and musculoskeletal abnormalities within 6 months. (C) Those who have no experience of using a smartphone (D) Others who are unlikely to be able to participate in the research by the researchers' judgment.
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	● Clinical data-Lung function test, blood test, exercise load test, strength test
Timepoint	Pre-test and post-test (2 times)
Primary Outcome(s) 2
Outcome	● Survey Data-Physical activity (IPAQ), quality of life (EQ-5D-3L), and smart healthcare service satisfaction survey.
Timepoint	Pre-test and post-test (2 times)
Secondary Outcome(s) 1
Outcome	● PGHD(patient-general health data) - Activity, blood pressure, pulse, body composition
Timepoint	Pre-test, 4 weeks,8 weeks, Post-test (4 times)

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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