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Development and Clinical Study of Rehabilitation Sports Program for Persons with Cervical Spinal Cord Injury

Status Approved

First Submitted Date

2021/03/08
Registered Date

2021/03/09
Last Updated Date

2021/03/08

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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	KCT0005980
Unique Protocol ID	NRCIRB-2016-03-029
Public/Brief Title	The Development and Clinical Study of Exercise Program for Persons with Cervical Spinal Cord Injury
Scientific Title	Development and Clinical Study of Rehabilitation Sports Program for Persons with Cervical Spinal Cord Injury
Acronym
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	NRCIRB-2016-03-029
Approval Date	2016-05-19
Institutional Review Board Name	Korea National Rehabilitation Center Institutional Review Board
Institutional Review Board Address	58, Samgaksan-ro, Gangbuk-gu, Seoul
Institutional Review Board Telephone	02-901-1817
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	Seon-Deok Eun
Title	Senior Researcher
Telephone	+82-2-901-1962
Affiliation	National Rehabilitation Center
Address	206, Rehabilitation Research Institute, 58 Samgaksan-ro, Gangbuk-gu, Seoul
Contact Person for Public Queries
Name	Dongheon Kang
Title	Researcher
Telephone	+82-2-901-1962
Affiliation	National Rehabilitation Center
Address	406, Rehabilitation Research Institute, 58 Samgaksan-ro, Gangbuk-gu, Seoul
Contact Person for Updating Information
Name	Dongheon Kang
Title	Researcher
Telephone	+82-2-901-1962
Affiliation	National Rehabilitation Center
Address	406, Rehabilitation Research Institute, 58 Samgaksan-ro, Gangbuk-gu, Seoul

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	Completed
Date of First Enrollment	2016-06-01 Actual
Target Number of Participant	25
Primary Completion Date	2016-10-31 , Actual
Study Completion Date	2017-06-19 , Actual
Name of Study	National Rehabilitation Center
Recruitment Status	Completed
Date of First Enrollment	2016-06-01 ,

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	National Rehabilitation Center
Organization Type	Government
Project ID	16-C-01

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	National Rehabilitation Center
Organization Type	Government

7. Study Summary

Study Summary Information
Lay Summary	1. Research purpose and background -In the case of spinal cord injury, the higher the level of damage and the more complete the degree of motor nerve damage, the more severe the dysfunction of the respiratory muscles appears. These respiratory complications have been reported as a major cause of death among people with spinal cord injuries, especially those with cervical spinal cord injury. -Despite these risks, people with cervical spinal cord injury. (C3-6, ASIA A-B) do not have much exercise they can do due to their low functional level and limited lung function. -Therefore, this study aims to develop a rehabilitation sports program that can improve lung function by maximizing the remaining function for people with cervical spinal cord injury, and to confirm the clinical effect thereof. 2. Research hypothesis -Develop rehabilitation sports programs for people with cervical spinal cord injury. -Conduct clinical study to verify the effectiveness of the developed rehabilitation sports program. 3. Clinical research plan -The developed rehabilitation sports program for people with cervical spinal cord injury was applied for 8 weeks. Pulmonary function was measured before and after the 8-week program.

Study Summary Information

Lay Summary

1. Research purpose and background
-In the case of spinal cord injury, the higher the level of damage and the more complete the degree of motor nerve damage, the more severe the dysfunction of the respiratory muscles appears. These respiratory complications have been reported as a major cause of death among people with spinal cord injuries, especially those with cervical spinal cord injury.
-Despite these risks, people with cervical spinal cord injury. (C3-6, ASIA A-B) do not have much exercise they can do due to their low functional level and limited lung function.
-Therefore, this study aims to develop a rehabilitation sports program that can improve lung function by maximizing the remaining function for people with cervical spinal cord injury, and to confirm the clinical effect thereof.

2. Research hypothesis
-Develop rehabilitation sports programs for people with cervical spinal cord injury.
-Conduct clinical study to verify the effectiveness of the developed rehabilitation sports program.

3. Clinical research plan
-The developed rehabilitation sports program for people with cervical spinal cord injury was applied for 8 weeks. Pulmonary function was measured before and after the 8-week program.

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	Treatment
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Others (exercise intervention)
Intervention Description	The program was developed in this study. Participants in the program participated in a total of 16 times, 60 minutes per session/twice a week/8 weeks.
Number of Arms	1
Arm 1	Arm Label Exercise group
	Target Number of Participant 25
	Arm Type Experimental
	Arm Description Participants of the program participated in a total of 16 times, 60 minutes per session/twice a week/8 weeks. This program consists of warm-up exercise, main exercise program, and cool-down exercise.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Quality of life Spinal Cord Injuries
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~80Year
	Description 1. A person with the highest level of cervical spinal cord injury (C3-C7) with complete motor nerve damage (ASIA A, B) 2. Currently non-smokers 3. Those who have never had chronic or acute heart disease or respiratory disease within the past or within 6 months 4. Those who had no comorbid damage such as deformation of the rib cage or fracture of the ribs prior to the occurrence of the accident. 5. Those who do not have spinal arthritis or neuromuscular disease that may affect lung function 6. A person who agrees to participate in the research, understands the words instructed by the researcher, and can fully cooperate in the research
Exclusion Criteria	1. Persons with cervical spinal cord injury (C3-C7) who are not disabled 2. Current smokers 3. Those with chronic, acute heart disease and respiratory disease within the past or 6 months 4. A person who has suffered concomitant damage such as deformation of the rib cage or fracture of the ribs prior to the occurrence of the accident. 5. Those with spinal arthritis or neuromuscular disease that may affect lung function 6. Those who do not understand the words instructed by the researcher
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	Lung function test
Timepoint	Before and after intervention
Secondary Outcome(s) 1
Outcome	muscle strength test
Timepoint	Before and after intervention
Secondary Outcome(s) 2
Outcome	Quality of life
Timepoint	Before and after intervention
Secondary Outcome(s) 3
Outcome	Depression
Timepoint	Before and after intervention
Secondary Outcome(s) 4
Outcome	Satisfaction with the program and experience analysis
Timepoint	Before and after intervention

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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