임상연구정보서비스

Search: Search

Clinical study to improve the ankle function in patients with stroke using an experimental device that induces passive ankle movement with functional electrical stimulation

Status Approved

First Submitted Date

2021/03/24
Registered Date

2021/04/05
Last Updated Date

2021/03/24

Move list page

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	KCT0006056
Unique Protocol ID	NRC-2017-04-035
Public/Brief Title	A cross-sectional study on the relationship between balance impairment and ankle function in patient with stroke
Scientific Title	Clinical study to improve the ankle function in patients with stroke using an experimental device that induces passive ankle movement with functional electrical stimulation
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	NRC-2017-04-035
Approval Date	2018-02-13
Institutional Review Board Name	Institutional review board of National Rehabilitation Center
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	Hogene Kim
Title	Dr.
Telephone	+82-2-901-1905
Affiliation	Ministry of Health & Welfare
Address	58 Samgaksan-ro, Gangbuk-gu, Seoul
Contact Person for Public Queries
Name	Ji-Eun Cho
Title	Dr.
Telephone	+82-2-901-1948
Affiliation	National Rehabilitation Center
Address	58 Samgaksan-ro, Gangbuk-gu, Seoul
Contact Person for Updating Information
Name	Ji-Eun Cho
Title	Dr.
Telephone	+82-2-901-1948
Affiliation	National Rehabilitation Center
Address	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	2018-03-01 Actual
Target Number of Participant	60
Primary Completion Date	2019-02-28 , Actual
Study Completion Date	2019-02-28 , Actual
Name of Study	National Rehabilitation Center
Recruitment Status	Completed
Date of First Enrollment	2018-03-01 ,

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	Research Institute
Project ID	NRCTR-IN18003

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	-Purpose: To identify the factors related to the balance ability of stroke patients and to analyze the factors that can best predict balance impairment. -Background: Balance impairments are common and multifactorial among patient with stroke. Ankle proprioception plays an important role in providing essential information during weight bearing and correlated with balance performance. However, the relationship between ankle proprioception and balance impairments has not been clearly explored in patient with stroke. -Methods: Participants (n=60) were assessed for various physical outcomes related ankle and balance functions. Evaluations included here were ankle range of motion, ankle proprioceptive sensation, ankle strength, Berg balance scale, Timed up and go test, Fugl-Meyer lower extremity, fall efficacy scale, and gait analysis. -Analysis: Multivariable logistic regressions and receiver operatig characteristic curve analysis were performed to predict balance damage using the Berg balance scale and the cut-off score of the Timed Up and Go test.

Study Summary Information

Lay Summary

-Purpose: To identify the factors related to the balance ability of stroke patients and to analyze the factors that can best predict balance impairment.

-Background: Balance impairments are common and multifactorial among patient with stroke. Ankle proprioception plays an important role in providing essential information during weight bearing and correlated with balance performance. However, the relationship between ankle proprioception and balance impairments has not been clearly explored in patient with stroke.

-Methods: Participants (n=60) were assessed for various physical outcomes related ankle and balance functions. Evaluations included here were ankle range of motion, ankle proprioceptive sensation, ankle strength, Berg balance scale, Timed up and go test, Fugl-Meyer lower extremity, fall efficacy scale, and gait analysis.

-Analysis: Multivariable logistic regressions and receiver operatig characteristic curve analysis were performed to predict balance damage using the Berg balance scale and the cut-off score of the Timed Up and Go test.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Case-only
Time Perspective	Cross-sectional
Target Number of Participant	60
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Chronic stroke
Cohort/ Group 1	Cohort/Group Description Patient with chronic stroke more than 3 months after stroke with impaired ankle function and balance
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Stroke patients over the age of 20 residing in Seoul
Sampling Method	Simple random sampling
Condition(s)/Problem(s)	* (I00-I99)Diseases of the circulatory system (I64)Stroke, not specified as haemorrhage or infarction stroke, hemiplegia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description (1) chronic stroke patients (2) age between 20 and 80 years (3) able to walk independently on level surface under supervision or sometimes using an assistive device for safety (Functional Ambulation Category (FAC) score>3) (4) no abnormal tone or slightly increased in ankle joint muscle group only at the end of passive ankle range of motion (Modified Ashworth Scale (MAS)<3)
Exclusion Criteria	(1) complications of orthopadic disorders (2) cognitive dysfunctions (Korean version of Mini Mental State Examination(K-MMSE) score<24) (3) mental illnesses
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	Ankle Function (range of motion, strength, proprioception)
Timepoint	After recruitment
Primary Outcome(s) 2
Outcome	Balance and Impairment of Lower limbs(Berg balance scale, Timed up and go, Fugl-Meyer Lower extremity)
Timepoint	After recruitment
Secondary Outcome(s) 1
Outcome	Fall efficacy scale
Timepoint	After recruitment
Secondary Outcome(s) 2
Outcome	Gait function on even and uneven terrains(step and joint kinematics)
Timepoint	After recruitment

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

Move list page Move to top