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Effect of vibrotactile bio-feedback providing pressure information in real time on static balance in 20s adults with chronic ankle instability

Status Approved

First Submitted Date

2021/03/26
Registered Date

2021/03/26
Last Updated Date

2021/03/26

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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	KCT0006034
Unique Protocol ID	1040647-202003-HR-001-03
Public/Brief Title	The effect of tactile feedback using pressure sensor-based vibrations on static balance in 20s adults with chronic ankle instability
Scientific Title	Effect of vibrotactile bio-feedback providing pressure information in real time on static balance in 20s adults with chronic ankle instability
Acronym	Vibrotactile bio-feedback providing pressure information in real time
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	1040647-202003-HR-001-03
Approval Date	2020-04-03
Institutional Review Board Name	Institutional review board of Daejeon University
Institutional Review Board Address	62, Daehak-ro, Dong-gu, Daejeon
Institutional Review Board Telephone	042-280-2786
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	Wonseob Shin
Title	Professor
Telephone	+82-42-280-2294
Affiliation	Daejeon University
Address	2423, Applied Science Museum, 62, Daehak-ro, Dong-gu, Daejeon
Contact Person for Public Queries
Name	Ho Kim
Title	MSc
Telephone	+82-42-280-2290
Affiliation	Daejeon University
Address	2508, Applied Science Museum, 62, Daehak-ro, Dong-gu, Daejeon
Contact Person for Updating Information
Name	Ho Kim
Title	MSc
Telephone	+82-42-280-2290
Affiliation	Daejeon University
Address	2508, Applied Science Museum, 62, Daehak-ro, Dong-gu, Daejeon

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	2020-04-06 Actual
Target Number of Participant	21
Primary Completion Date	2020-05-31 , Actual
Study Completion Date	2020-08-31 , Actual
Name of Study	Daejeon University
Recruitment Status	Completed
Date of First Enrollment	2020-04-06 ,

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	Daejeon University
Organization Type	University
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Daejeon University
Organization Type	University

7. Study Summary

Study Summary Information
Lay Summary	※ Background Previous studies suggest that chronic ankle instability (CAI) is a cause of repeated ankle joint injury due to the problem with postural control from reduced proprioception and postural agitation. There are many reports of intervention and treatments of CAI using balance exercise programs, but there is a lack of research in intervention programs using various bio-feedback environment and based pressure sensor information. ※ Hypothesis The hypothesis of this study is that vibrotactile bio-feedback providing pressure information in real time will improve static balance such as velocity and path length in adults in their 20s with CAI. CAI is a chronic musculoskeletal disease with a high level of relapse that can lower patients quality of life by reducing various neurological abilities such as proprioception. In this regard, the hypothesis of this study is that the newly developed vibrotactile bio-feedback providing pressure information in real time equipment will improve static balance such as sway speed and length of movement in adults in their twenties with chronic ankle instability. ※ Purpose The purpose of this research is to provide a more effective bio-feedback intervention program for proprioception and postural control in CAI.

Study Summary Information

Lay Summary

※ Background
Previous studies suggest that chronic ankle instability (CAI) is a cause of repeated ankle joint injury due to the problem with postural control from reduced proprioception and postural agitation. There are many reports of intervention and treatments of CAI using balance exercise programs, but there is a lack of research in intervention programs using various bio-feedback environment and based pressure sensor information.

※ Hypothesis
The hypothesis of this study is that vibrotactile bio-feedback providing pressure information in real time will improve static balance such as velocity and path length in adults in their 20s with CAI. 
CAI is a chronic musculoskeletal disease with a high level of relapse that can lower patients quality of life by reducing various neurological abilities such as proprioception. In this regard, the hypothesis of this study is that the newly developed vibrotactile bio-feedback providing pressure information in real time equipment will improve static balance such as sway speed and length of movement in adults in their twenties with chronic ankle instability.

※ Purpose
The purpose of this research is to provide a more effective bio-feedback intervention program for proprioception and postural control in CAI.

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	Supportive Care
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	RCT
Intervention Type	Others (Research and development equipment)
Intervention Description	- Twenty-one subjects with chronic ankle instability were selected. With the R Studio program (R Studio Desktop 1.2.5033), the measurement sequence is randomly placed in a tactile bio-feedback, visual bio-feedback, and a standing position without bio-feedback, one day each for three days. -We investigate whether there was any difference in the static balance ability of the standing posture in different feedback situations. -To measure the static balance ability, maintain a standing posture for a total of 3 sets of 30 seconds with both feet naturally placed on the Wii balance board, and the rest time between sets is 3 minutes. -Data extraction is done by Balancia software ver 2.0, extract data in 100Hz increments. -The distance from the Wii balance board to the wall is equal to 2m. -Subjects are exposed to the experiment and are given a 24-hour washing out to minimize their adaptation.
Number of Arms	1
Arm 1	Arm Label Adults in their twenties with chronic ankle instability
	Target Number of Participant 21
	Arm Type Experimental
	Arm Description - One day each for 3 days with random measurement sequence 1. Newly developed vibrotactile bio-feedback providing pressure information in real time 2. Newly developed visual bio-feedback providing pressure information in real time 3. General standing posture without bio-feedback Proceed with the experiment. - To measure the static balance ability, keep both feet on the Wii balance board and maintain a standing posture for a total of 3 sets of 30 seconds. - In order to minimize the adaptation of the subject, the break between sets is set to 3 minutes. - The distance from the Wii balance board to the wall is equal to 2m. - Subjects are exposed to the experiment and are subjected to washing out for 24 hours to minimize their adaptation.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (M00-M99)Diseases of the musculoskeletal system and connective tissue (M25.37)Other instability of joint, ankle and foot Ankle, Disease, Musculoskeletal Diseases
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~29Year
	Description (1) Those who have not experienced ankle sprains in the past 6 weeks (2) Those with a score of 24 or less on the Cumberland ankle instability tool (CAIT)
Exclusion Criteria	(1) Those who do not have neurological or orthopedic diseases that cause movement disorders (2) Those with a history of surgery on the lower extremities in the last 1 year
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	/Safety/Efficacy
Outcome	Static balance ability (Sway velocity{cm/s})
Timepoint	Biofeedback device being applied
Secondary Outcome(s) 1
Outcome	Static balance ability (Path length{cm})
Timepoint	Biofeedback device being applied

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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