임상연구정보서비스

Search: Search

Clinical study on the evaluation and training of ankle and gait function using an powered ankle-foot-orthosis

Status Approved

First Submitted Date

2021/02/19
Registered Date

2021/04/07
Last Updated Date

2022/10/12

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	KCT0006061
Unique Protocol ID	NRC-2019-03-021
Public/Brief Title	Clinical study on the evaluation and training of ankle and gait function using an powered ankle-foot-orthosis
Scientific Title	Clinical study on the evaluation and training of ankle and gait function using an powered ankle-foot-orthosis
Acronym	Comparison of walking function by conditions of AFO
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	NRC-2019-03-021
Approval Date	2021-02-02
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	Recruiting
Date of First Enrollment	2021-05-17 Actual
Target Number of Participant	40
Primary Completion Date	2023-04-06 , Anticipated
Study Completion Date	2023-04-06 , Anticipated
Name of Study	National Rehabilitation Center
Recruitment Status	Recruiting
Date of First Enrollment	2021-05-17 ,

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	Others
Project ID	NRCTR-IN21003

6. Sponsor Organization

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

7. Study Summary

Study Summary Information
Lay Summary	-Background: Although the ankle function of stroke patients plays an important role in gait, balance and daily life, the development of effective passive and powered ankle-foot-orthosis (AFO) for patients with stroke is insufficient. Therefore, we plan to study an effective AFO by comparing gait according to the wearing conditions of the self-developed AFO. -Purpose: The purpose of this study is to investigate the improvement of walking function wearing AFO by comparing the difference in ankle and gait function when walking wearing a powered AFO, passive AFO, and conventional AFO. -Hypothesis: There is a difference in the ankle and gait functions of healthy adults and patients with stroke compared to walking with different conditions of AFO. -Methods: Recruiting 20 healthy adults and 20 stroke patients, and proceeding to evaluate the gait function according to the five conditions of AFO. 1) Wearing an powered AFO (with power) 2) Wearing an powered AFO (with no power) 3) Wearing a passive AFO 4) Wearing a conventional AFO 5) Not wearing AFO

Study Summary Information

Lay Summary

-Background: Although the ankle function of stroke patients plays an important role in gait, balance and daily life, the development of effective passive and powered ankle-foot-orthosis (AFO) for patients with stroke is insufficient. Therefore, we plan to study an effective AFO by comparing gait according to the wearing conditions of the self-developed AFO.

-Purpose: The  purpose of this study is to investigate the improvement of walking function wearing AFO by comparing the difference in ankle and gait function when walking wearing a powered AFO, passive AFO, and conventional AFO.

-Hypothesis: There is a difference in the ankle and gait functions of healthy adults and patients with stroke compared to walking with different conditions of AFO.

-Methods: Recruiting 20 healthy adults and 20 stroke patients, and proceeding to evaluate the gait function according to the five conditions of AFO.
1) Wearing an powered AFO (with power)
2) Wearing an  powered AFO (with no power)
3) Wearing a passive AFO
4) Wearing a conventional AFO 
5) Not wearing AFO

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-control
Time Perspective	Cross-sectional
Target Number of Participant	40
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Patients with stroke
Cohort/ Group 1	Cohort/Group Description Evaluation of gait kinematics, metabolic cost, brain activation during walking with ankle-foot-orthosis
Cohort/ Group 2	Cohort/Group Label Healthy adults
Cohort/ Group 2	Cohort/Group Description Evaluation of gait kinematics, metabolic cost, brain activation during walking with ankle-foot-orthosis
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Chronic stroke patients or age matched healthy adults
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
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~60Year
	Description (1) Chronic stroke (2) Age between 20 and 60 (3) Those with a functional ambulation categories of 3 or more (4) Those with ankle dysfunction such as foot drop during walking (5) Mini-Mental Status Examination ≥ 24
Exclusion Criteria	(1) Those with contractures or pain in the lower extremities that may affect training (2) Those who have a history of musculoskeletal system in the ankle (fracture, amputation, sprain, etc.) (3) Those who participated in other exercise programs that may affect ankle function within 6 months
Healthy Volunteers	Yes

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	gait kinematics
Timepoint	One evaluation after recruitment
Primary Outcome(s) 2
Outcome	Muscle activity during walking
Timepoint	One evaluation after recruitment
Secondary Outcome(s) 1
Outcome	Metabolic cost
Timepoint	One evaluation after recruitment
Secondary Outcome(s) 2
Outcome	Brain activity during walking
Timepoint	One evaluation after recruitment
Secondary Outcome(s) 3
Outcome	Balance functions(Berg balance scale, timed up and go)
Timepoint	One evaluation after recruitment
Secondary Outcome(s) 4
Outcome	Ankle functions(Ankle Range of motion, Manual muscle test, Plantar cutaneous sensation, Ankle Proprioception, Ankle stiffness, Ankle anthropometry)
Timepoint	One evaluation after recruitment
Secondary Outcome(s) 5
Outcome	Satisfaction survey (Stroke Impact Scale, Back Depression Inventory)
Timepoint	One evaluation 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