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The Prediction and Prevention of Disease by Using Big Data in Motion Analysis

Primary Purpose

Ankylosing Spondylitis, Adolescent Idiopathic Scoliosis, Gait Analysis

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Inertial measurement unit sensor-based gait analysis system
Sponsored by
Pusan National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankylosing Spondylitis focused on measuring Gait analysis, Spine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Pusan National University Hospital orthopedics, otorhinolaryngology, neurology outpatient or inpatient who agreed to the study.
  • For adult men and women 18 years of age or older.

Exclusion Criteria:

  • Patients unable to walk independently.

Sites / Locations

  • Pusan National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gait analysis

Arm Description

Gait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group.

Outcomes

Primary Outcome Measures

gait asymmetry
comparing the swing times performed by one leg with respect to the swing times performed by the other, according to the following formula: GA = 100 x ln(SSWT/LSWT)

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
April 27, 2021
Sponsor
Pusan National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04867148
Brief Title
The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
Official Title
The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
February 20, 2020 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Hospital

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
Variable patterns of gait disturbance can be found in patients with spine disease including the problems of gait initiation, freezing of gait, reduced balance and postural control, reduced step lengths, increased step times, and slow walking speed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis, Adolescent Idiopathic Scoliosis, Gait Analysis
Keywords
Gait analysis, Spine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gait analysis
Arm Type
Experimental
Arm Description
Gait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group.
Intervention Type
Device
Intervention Name(s)
Inertial measurement unit sensor-based gait analysis system
Intervention Description
Gait analysis was performed on 20-m long corridor to collect gait data on more than 23 strides. The gait protocol was performed with an IMU sensor-based gait analysis system (DynaStab™, JEIOS, South Korea) consisting of a shoe-type data logger (Smart Balance1 SB-1, JEIOS, South Korea) and a data acquisition system (DynaStab-Spotfire1, Tibco Spotfire 7.10). The shoe-type data logger included an IMU sensor (IMU-3000™, InvenSense, USA) that measured tri-axial acceleration (up to ± 6 g) and tri-axial angular 136 velocity (up to ± 500˚ s-1) along three orthogonal axes.12,16 The IMU sensors were installed in both shoe outsoles, and the data were transmitted wirelessly to a data acquisition system via Bluetooth®. Shoe sizes were adapted to each participant, with available sizes ranging from 225 mm to 280 mm. The local coordinate system for the IMU sensors included the 140 anteroposterior, mediolateral, and vertical directions.
Primary Outcome Measure Information:
Title
gait asymmetry
Description
comparing the swing times performed by one leg with respect to the swing times performed by the other, according to the following formula: GA = 100 x ln(SSWT/LSWT)
Time Frame
for 1minute walking

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pusan National University Hospital orthopedics, otorhinolaryngology, neurology outpatient or inpatient who agreed to the study. For adult men and women 18 years of age or older. Exclusion Criteria: Patients unable to walk independently.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jungsub Lee, M.D., Ph.D.
Organizational Affiliation
Pusan National University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Pusan National University Hospital
City
Busan
State/Province
Seo-gu
ZIP/Postal Code
49241
Country
Korea, Republic of

12. IPD Sharing Statement

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The Prediction and Prevention of Disease by Using Big Data in Motion Analysis

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