The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Primary Purpose
Ambulation Difficulty
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Turning
Sponsored by
About this trial
This is an interventional basic science trial for Ambulation Difficulty
Eligibility Criteria
Inclusion Criteria:
- Able to walk 10 m independently without any device.
Exclusion Criteria:
- Dizzy causing by eye disorders or vestibular disease.
- Any disease which involved in gait performance.
- Can't follow the order by investigator during task.
Sites / Locations
- National Yang-Ming UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Normal subjects
Arm Description
Outcomes
Primary Outcome Measures
Turning step count
record numbers of step during turning
Turing time
record second which subject spend during turning
Stride length during turning
record the distance of bipedal stride length respectively
Walking speed approached turning
record the velocity and change of velocity before start turning
Turning angle
record the total turning angle and bipedal turning angle each step
Secondary Outcome Measures
Full Information
NCT ID
NCT03405896
First Posted
January 8, 2018
Last Updated
November 5, 2018
Sponsor
National Yang Ming University
1. Study Identification
Unique Protocol Identification Number
NCT03405896
Brief Title
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Official Title
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
August 23, 2019 (Anticipated)
Study Completion Date
August 23, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Yang Ming University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
Detailed Description
Subjects are reclaimed to finish several turning task under different turning angle.
The wearable system is patched on both subjects' legs and waist, to assess turning characteristics under different turning angle.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ambulation Difficulty
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Normal subjects
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Turning
Intervention Description
start to walk with normal speed, and then turn to approach the terminal under different angle.
Primary Outcome Measure Information:
Title
Turning step count
Description
record numbers of step during turning
Time Frame
pre-test and post-test within a week
Title
Turing time
Description
record second which subject spend during turning
Time Frame
pre-test and post-test within a week
Title
Stride length during turning
Description
record the distance of bipedal stride length respectively
Time Frame
pre-test and post-test within a week
Title
Walking speed approached turning
Description
record the velocity and change of velocity before start turning
Time Frame
pre-test and post-test within a week
Title
Turning angle
Description
record the total turning angle and bipedal turning angle each step
Time Frame
pre-test and post-test within a week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Able to walk 10 m independently without any device.
Exclusion Criteria:
Dizzy causing by eye disorders or vestibular disease.
Any disease which involved in gait performance.
Can't follow the order by investigator during task.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yea-Ru Yang, PhD
Phone
+886-2-28267279
Email
yryang@ym.edu.tw
Facility Information:
Facility Name
National Yang-Ming University
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yea-Ru Yang, PhD
Phone
+886-2-28267279
Email
yryang@ym.edu.tw
12. IPD Sharing Statement
Learn more about this trial
The Validity and Reliability of a Wearable System for Assessing Turning Characteristics.
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