Hallux ValgusNCT06563037
The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern
An observational study of Hallux Valgus, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey at 1 site in Turkey (Türkiye).
Trial summary
Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- How many people
- 92 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 May 2022to 10 Oct 2022
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: At leat 3 years of experienced judo and weightlifters
Who may be able to join
- At least 3 years of experience in their respective sports.
Who cannot join
- Athletes with acute injuries
Trial locations and contacts
1 site in 1 country.
About this study
Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. It is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. The aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes.
Materials and methods: This is a cross-sectional observational study. The study included 92 athletes with at least 3 years of experience in their respective sports.
Read the detailed description
Athletes without acute injuries that could affect performance tests were included. Demographic data were collected, and the hallux valgus angle was measured using a goniometer. A standard warm-up protocol was then administered. A drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras.
- Conditions
- Hallux Valgus
- Being tested
- No intervention
- Keywords
- Hallux valgus, Injury, Judo, Knee, Weightlifting
- Medical subject headings
- Hallux Valgus, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an observational study
| Study group | Role | What they receive |
|---|---|---|
| Weightlifters and Judo Athletes | At least 3 years of experience in their respective sports. Athletes without acute injuries that could affect performance tests were included. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drop Jump Test
The drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras. Two cameras were used, one placed in the coronal plane to view the participant from the front, and the other placed in the sagittal plane to view from the left side. Reflective markers were attached to the reference points for measurements
Measured: 30 minutes
Secondary outcomes (1)
Hallux Valgus Angle Measurement
Hallux valgus angle involves measuring the angle between the long axis of the first metatarsal bone and the longitudinal axis of the first phalanx [15]. The normal value ranges from 8˚ to 10˚. However, some authors suggest lateral deviation up to 15˚ may be considered normal
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2024
- Study start5 May 2022
- Primary completion7 Jun 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hallux ValgusStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Serdar Atalay, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06563037
- Sponsor's protocol ID
- E-77082166-604.01.02-39435
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
PubMed 15722287
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Hallux Valgus Angle on Dynamic Knee Movement Pattern
- ClinicalTrials.gov ID
- NCT06563037
- Acronym / sponsor ID
- E-77082166-604.01.02-39435
- Conditions
- Hallux Valgus
- Keywords
- Hallux valgus, Injury, Judo, Knee, Weightlifting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 7 Jun 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 20 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.
Abstract Background/aim: Little is known about the relationship between hallux valgus and the alignment of proximal joints. Dynamic knee valgus is a movement pattern characterized by excessive knee abduction along with femoral adduction, internal rotation, and relative external tibial rotation. It is more prevalent in females and exacerbates during landing in jumping, predisposing athletes to injuries. The aim of this study is to investigate the effect of hallux valgus deformity on dynamic knee movement pattern and lower extremity injuries in athletes.
Materials and methods: This is a cross-sectional observational study. The study included 92 athletes with at least 3 years of experience in their respective sports.
Detailed description
Athletes without acute injuries that could affect performance tests were included. Demographic data were collected, and the hallux valgus angle was measured using a goniometer. A standard warm-up protocol was then administered. A drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Weightlifters and Judo Athletes | – | Other: No interventionAt least 3 years of experience in their respective sports. Athletes without acute injuries that could affect performance tests were included. |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- At leat 3 years of experienced judo and weightlifters
Key inclusion criteria (1 listed)
- At least 3 years of experience in their respective sports.
Key exclusion criteria (1 listed)
- Athletes with acute injuries
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 |
|---|---|---|
| No interventionThis is an observational study | Other | Weightlifters and Judo Athletes |
Primary outcome
Drop Jump Test
Time frame: 30 minutes
The drop jump test from a 30cm platform was conducted, and images captured during the test were analyzed in 2D using Kistler+Noraxon Measurement Device cameras. Two cameras were used, one placed in the coronal plane to view the participant from the front, and the other placed in the sagittal plane to view from the left side. Reflective markers were attached to the reference points for measurements
1 secondary outcome
Hallux Valgus Angle Measurement
Time frame: 10 minutes
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 20 Aug 2024.
- Background: PubMed 15722287Hewett TE, Myer GD, Ford KR, Heidt RS Jr, Colosimo AJ, McLean SG, van den Bogert AJ, Paterno MV, Succop P. Biomechanical measures of neuromuscular control and valgus loading of the knee predict anterior cruciate ligament injury risk in female athletes: a prospective study. Am J Sports Med. 2005 Apr;33(4):492-501. doi: 10.1177/0363546504269591. Epub 2005 Feb 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hallux Valgus, run by Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey 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 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: finished, as of the sponsor's last update on 20 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?
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?
Drop Jump Test (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06563037, which also lists 1 linked publication.
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 20 Aug 2024.