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NCT04867148 Clinical Trial

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

Ankylosing Spondylitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04867148
Other study ID # PNUH orthopaedics
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date December 31, 2022

Study information
Verified date April 2021
Source Pusan National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date December 31, 2022
Est. primary completion date February 20, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Inertial measurement unit sensor-based gait analysis system
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.

Locations
Country Name City State
Korea, Republic of Pusan National University Hospital Busan Seo-gu

Sponsors (1)
Lead Sponsor Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) for 1minute walking
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