The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
1 other identifier
interventional
2,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2020
CompletedFirst Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 30, 2021
April 1, 2021
6 months
April 27, 2021
April 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Gait analysis
EXPERIMENTALGait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients unable to walk independently.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pusan National University Hospital
Busan, Seo-gu, 49241, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
jungsub Lee, M.D., Ph.D.
Pusan National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 27, 2021
First Posted
April 30, 2021
Study Start
September 1, 2019
Primary Completion
February 20, 2020
Study Completion
December 31, 2022
Last Updated
April 30, 2021
Record last verified: 2021-04