Device is Used for Evalution (Event)NCT05731635
Plantar Pressure Values in Patients With Ankylosing Spondylitis
An observational study of Device is Used for Evalution (Event), run by Amasya University.
Trial summary
this study was discovered that clinical and radiological characteristics were related to plantar pressure assessments in patients with AS. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Device is Used for Evalution (Event)
- What is being tested?
- plantar pressure values
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2011to 1 Dec 2012
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Seventy-five adult patients who applied to Celal Bayar University outpatient clinics and were diagnosed with AS according to the modified New York criteria were included in the study.
Who may be able to join
- Exclusion Criteria: Patients with cognitive dysfunction, vision loss that would prevent walking on the pedobarography platform, history of surgery and neurological deficit in the lower extremity, and patients who could not walk independently
- -
Who cannot join
None listed.
About this study
Official title: Plantar Pressure Values in Patients With Ankylosing Spondylitis and Their Relation With Clinical and Radiological Parameters
this study was discovered that clinical and radiological characteristics were related to plantar pressure assessments in patients with AS.
Read the detailed description
Determine the correlation between the plantar pressure readings of AS patients and the clinical and radiological measures utilized in the monitoring of the condition.
Method: This study covered 75 participants. The quality of life was measured using ASQoL, BASMI, BASFI, and BASDAI, and demographic information was also recorded. The pedobarographic evaluations included the recording of static and dynamic plantar pressures
- Conditions
- Device is Used for Evalution (Event)
- Being tested
- plantar pressure values
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plantar pressure valuesDiagnostic test
Walking enables for extremely accurate and pointwise ground response force measurement because to plantar pressure measurement (pedobarography). It allows for the objective comparison and evaluation of the dynamic pressure put on the ground by the foot in contact with it. It is often used in clinics to assess foot mechanics and associated disorders that affect the foot sole. Additionally, plantar pressure analysis is useful for identifying, treating, and monitoring conditions that impact the lower extremity's axial alignment.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pedobarographic Measurements
The cases' foot sole pressures were measured using a pedobarography device of the RsScan International brand (1m, 3D Scientific+Balance software model). This technology measures both static (when standing) and dynamic foot sole pressures (walking). The device's pressure measuring platform has an overall frame size of 1068x418x12 mm, 8192 sensors totaling 4 sensors per cm2, and a sensor area of 975x325 mm. It has a 500 Hz frequency, a 0-200 N/cm2 pressure range, a 15° to 40° C temperature range, and a 220/110 volt connecting power.
Measured: at begining
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Dec 2011
- Primary completion1 Dec 2012
- Study completion1 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Device is Used for Evalution (Event)Studies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esra Topçu, Amasya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05731635
- Sponsor's protocol ID
- 159
- Status last verified
- Feb 2023
- First submitted
- 26 Jan 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar Pressure Values in Patients With Ankylosing Spondylitis and Their Relation With Clinical and Radiological Parameters
- ClinicalTrials.gov ID
- NCT05731635
- Acronym / sponsor ID
- 159
- Conditions
- Device is Used for Evalution (Event)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 1 Dec 2012 (actual)
- Study completion
- 1 Dec 2012 (actual)
- First posted
- 16 Feb 2023 (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.
this study was discovered that clinical and radiological characteristics were related to plantar pressure assessments in patients with AS.
Detailed description
Determine the correlation between the plantar pressure readings of AS patients and the clinical and radiological measures utilized in the monitoring of the condition.
Method: This study covered 75 participants. The quality of life was measured using ASQoL, BASMI, BASFI, and BASDAI, and demographic information was also recorded. The pedobarographic evaluations included the recording of static and dynamic plantar pressures
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Seventy-five adult patients who applied to Celal Bayar University outpatient clinics and were diagnosed with AS according to the modified New York criteria were included in the study.
Key inclusion criteria (2 listed)
- Exclusion Criteria: Patients with cognitive dysfunction, vision loss that would prevent walking on the pedobarography platform, history of surgery and neurological deficit in the lower extremity, and patients who could not walk independently
- -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| plantar pressure valuesWalking enables for extremely accurate and pointwise ground response force measurement because to plantar pressure measurement (pedobarography). It allows for the objective comparison and evaluation of the dynamic pressure put on the ground by the foot in contact with it. It is often used in clinics to assess foot mechanics and associated disorders that affect the foot sole. Additionally, plantar pressure analysis is useful for identifying, treating, and monitoring conditions that impact the lower extremity's axial alignment. | Diagnostic test | – |
Primary outcome
Pedobarographic Measurements
Time frame: at begining
The cases' foot sole pressures were measured using a pedobarography device of the RsScan International brand (1m, 3D Scientific+Balance software model). This technology measures both static (when standing) and dynamic foot sole pressures (walking). The device's pressure measuring platform has an overall frame size of 1068x418x12 mm, 8192 sensors totaling 4 sensors per cm2, and a sensor area of 975x325 mm. It has a 500 Hz frequency, a 0-200 N/cm2 pressure range, a 15° to 40° C temperature range, and a 220/110 volt connecting power.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Device is Used for Evalution (Event), run by Amasya University.
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 0 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: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pedobarographic Measurements (time frame: at begining). 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 16 Feb 2023; AzTrials last refreshed its copy on 6 Nov 2026.