Ankylosing SpondylitisNCT04867148
The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
A study testing Inertial measurement unit sensor-based gait analysis system in people with Ankylosing Spondylitis and Adolescent Idiopathic Scoliosis, run by Pusan National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis, Adolescent Idiopathic Scoliosis, Gait Analysis
- What is being tested?
- Inertial measurement unit sensor-based gait analysis system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Sep 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients unable to walk independently.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Inertial measurement unit sensor-based gait analysis system
- Keywords
- Gait analysis, Spine
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inertial measurement unit sensor-based gait analysis systemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Gait analysis | Experimental | Gait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group. Receives: Device: Inertial measurement unit sensor-based gait analysis system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: for 1minute walking
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2021
- Study start1 Sep 2019
- Primary completion20 Feb 2020
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lee Jung Sub, Pusan National University Hospital
- Investigators
- jungsub Lee, M.D., Ph.D., Study chair, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04867148
- Sponsor's protocol ID
- PNUH orthopaedics
- Status last verified
- Apr 2021
- First submitted
- 27 Apr 2021
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prediction and Prevention of Disease by Using Big Data in Motion Analysis
- ClinicalTrials.gov ID
- NCT04867148
- Acronym / sponsor ID
- PNUH orthopaedics
- Keywords
- Gait analysis, Spine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gait analysis | Experimental | Device: Inertial measurement unit sensor-based gait analysis systemGait analysis of patients with ankylosing spondylitis, patients with adoldescent idiopathic scoliosis and control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable to walk independently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inertial measurement unit sensor-based gait analysis systemGait 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. | Device | Gait analysis |
Primary outcome
gait asymmetry
Time frame: for 1minute walking
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
jungsub Lee, M.D., Ph.D. study chair
Pusan National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inertial measurement unit sensor-based gait analysis system in people with Ankylosing Spondylitis and Adolescent Idiopathic Scoliosis, run by Pusan National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait asymmetry (time frame: for 1minute walking). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.