Femoroacetabular ImpingementNCT06536088
The Relationship Between Gait and Severity of Femoroacetabular Impingement
An observational study of Femoroacetabular Impingement, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the spatiotemporal gait parameters of symptomatic femoroacetabular impingement (FAI) patients scheduled for hip arthroscopy are evaluated. Radiological measurements, including the Alpha angle (AA), Lateral Center-Edge Angle (LCEA), and Kellgren-Lawrence (KL) osteoarthritis classification, are recorded… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Walking assesment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 30 Dec 2024
- 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 18 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients scheduled for hip arthroscopy due to Femoroacetabular impingement syndrome at the Department of Orthopedics and Traumatology, Gazi University Faculty of Medicine, along with a healthy control group matched for age and gender, will be included in the study.
Who may be able to join
- Patients with femoroacetabular impingement scheduled for hip arthroscopy
Who cannot join
- Severe hip osteoarthritis
- Hip dysplasia
- Previous ipsilateral and/or contralateral hip surgery,
- Any orthopedic or neurologic pathology that may affect gait patterns
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gazi University Hospital
Ankara, 06500
İnci H Ayas, 0 312 216 26 21, inciayass@gmail.com
About this study
Official title: The Relationship Between Spatiotemporal Gait Parameters and Imaging-based Characteristics of Femoroacetabular Impingement (FAI) in Symptomatic Individuals
In this study, the spatiotemporal gait parameters of symptomatic femoroacetabular impingement (FAI) patients scheduled for hip arthroscopy are evaluated. Radiological measurements, including the Alpha angle (AA), Lateral Center-Edge Angle (LCEA), and Kellgren-Lawrence (KL) osteoarthritis classification, are recorded from patient files. The relationship between these radiological measurements and walking parameters is assessed. Additionally, the spatiotemporal gait parameters of FAI patients are compared with those of a healthy control group.
Walking assessments provide valuable insights into how Femoroacetabular Impingement (FAI) affects movement and aid in evaluating treatment outcomes. Research indicates that individuals with FAI experience reduced hip motion and slower walking speeds. By analyzing spatiotemporal gait parameters-such as gait velocity, cadence, step length, and vertical center of mass-the impact of FAI on walking can be better understood, leading to the development of targeted treatment strategies. The goal is to explore the correlation between these gait parameters and imaging-based FAI characteristics in affected individuals.
Read the detailed description
Patients and control groups are compared using the paired samples t-test for parametric data and the Wilcoxon signed ranks test for nonparametric data. The relationship between gait parameters and imaging-based FAI characteristics is examined by calculating the Pearson correlation coefficient (r) for parametric data and the Spearman rank correlation coefficient (rho) for non-parametric data.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Walking assesment
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking assesmentOther
Spatiotemporal walking assessments are performed using the Gait Analyzer app (version 0.9.95.0) on a smartphone. Participants who can walk independently without assistance walk a 25-meter path at their normal speed, with the smartphone securely attached to their body above the third lumbar vertebra using a belt. The app records gait velocity, cadence, step time, step length, and vertical center of mass for all participants.
| Study group | Role | What they receive |
|---|---|---|
| Patient with Femoroacetabular Impingement | Symptomatic femoroacetabular impingement patients scheduled for hip arthroscopy Receives: Other: Walking assesment | |
| Control group | Healthy indivicuals without Femoroacetabular Impingement Receives: Other: Walking assesment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait velocity
Gait velocity, also known as walking speed, is a crucial parameter in spatiotemporal gait analysis. It refers to the rate at which an individual walks over a given distance and is typically measured in meters per second (m/s).
Measured: Baseline
Cadence
Cadence refers to the number of steps a person takes per minute while walking.
Measured: Baseline
Step length
Step length refers to the distance covered between two consecutive footfalls of opposite feet.
Measured: Baseline
Vertical center of mass
The vertical center of mass refers to the vertical position of the body's center of mass during walking. It is the point where the body's mass is considered to be concentrated and it fluctuates as the person moves.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start1 Jan 2022
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İnci Hazal Ayas, Gazi University
- Investigators
- Ulunay Kanatlı, Professor, Study director, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06536088
- Sponsor's protocol ID
- Iayas10
- Status last verified
- Jul 2024
- First submitted
- 29 Jul 2024
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Spatiotemporal Gait Parameters and Imaging-based Characteristics of Femoroacetabular Impingement (FAI) in Symptomatic Individuals
- ClinicalTrials.gov ID
- NCT06536088
- Acronym / sponsor ID
- Iayas10
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Aug 2024 (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.
In this study, the spatiotemporal gait parameters of symptomatic femoroacetabular impingement (FAI) patients scheduled for hip arthroscopy are evaluated. Radiological measurements, including the Alpha angle (AA), Lateral Center-Edge Angle (LCEA), and Kellgren-Lawrence (KL) osteoarthritis classification, are recorded from patient files. The relationship between these radiological measurements and walking parameters is assessed. Additionally, the spatiotemporal gait parameters of FAI patients are compared with those of a healthy control group.
Walking assessments provide valuable insights into how Femoroacetabular Impingement (FAI) affects movement and aid in evaluating treatment outcomes. Research indicates that individuals with FAI experience reduced hip motion and slower walking speeds. By analyzing spatiotemporal gait parameters-such as gait velocity, cadence, step length, and vertical center of mass-the impact of FAI on walking can be better understood, leading to the development of targeted treatment strategies. The goal is to explore the correlation between these gait parameters and imaging-based FAI characteristics in affected individuals.
Detailed description
Patients and control groups are compared using the paired samples t-test for parametric data and the Wilcoxon signed ranks test for nonparametric data. The relationship between gait parameters and imaging-based FAI characteristics is examined by calculating the Pearson correlation coefficient (r) for parametric data and the Spearman rank correlation coefficient (rho) for non-parametric data.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Femoroacetabular Impingement | – | Other: Walking assesmentSymptomatic femoroacetabular impingement patients scheduled for hip arthroscopy |
| Control group | – | Other: Walking assesmentHealthy indivicuals without Femoroacetabular Impingement |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for hip arthroscopy due to Femoroacetabular impingement syndrome at the Department of Orthopedics and Traumatology, Gazi University Faculty of Medicine, along with a healthy control group matched for age and gender, will be included in the study.
Key inclusion criteria (1 listed)
- Patients with femoroacetabular impingement scheduled for hip arthroscopy
Key exclusion criteria (4 listed)
- Severe hip osteoarthritis
- Hip dysplasia
- Previous ipsilateral and/or contralateral hip surgery,
- Any orthopedic or neurologic pathology that may affect gait patterns
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 |
|---|---|---|
| Walking assesmentSpatiotemporal walking assessments are performed using the Gait Analyzer app (version 0.9.95.0) on a smartphone. Participants who can walk independently without assistance walk a 25-meter path at their normal speed, with the smartphone securely attached to their body above the third lumbar vertebra using a belt. The app records gait velocity, cadence, step time, step length, and vertical center of mass for all participants. | Other | Control group, Patient with Femoroacetabular Impingement |
Primary outcome
Gait velocity
Time frame: Baseline
Gait velocity, also known as walking speed, is a crucial parameter in spatiotemporal gait analysis. It refers to the rate at which an individual walks over a given distance and is typically measured in meters per second (m/s).
Cadence
Time frame: Baseline
Cadence refers to the number of steps a person takes per minute while walking.
Step length
Time frame: Baseline
Step length refers to the distance covered between two consecutive footfalls of opposite feet.
Vertical center of mass
Time frame: Baseline
The vertical center of mass refers to the vertical position of the body's center of mass during walking. It is the point where the body's mass is considered to be concentrated and it fluctuates as the person moves.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
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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.
Ulunay Kanatlı, Professor study director
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoroacetabular Impingement, run by Gazi University at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 2 Aug 2024. 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 Turkey (Türkiye). 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?
Contact İnci H Ayas, Msc (05071740342, inciayass@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait velocity (time frame: Baseline). The study lists 4 primary outcomes in all. 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 2 Aug 2024.