Hallux ValgusNCT07177768
Acute Effects of Prolonged Walking on Hallux Valgus
A study testing Prolonged walking in people with Hallux Valgus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Hallux valgus is a progressive foot deformity characterized by lateral deviation of the great toe and medial displacement of the first metatarsal head. While pain is a common symptom among individuals with HV, alterations in plantar pressure distribution and impaired balance are also frequently observed. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hallux Valgus
- What is being tested?
- Prolonged walking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2025to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hallux Valgus Group Criteria:
- Individuals aged between 18 and 55 years
- Being diagnosed with hallux valgus
- Control Group Criteria:
- Individuals aged between 18 and 55 years
- Classified as grade A according to the Manchester Scale
- Being a volunteer
Who cannot join
- History of previous foot or ankle surgery
- Having a systemic diseases
- Having a neurological disorders
- Having a vestibular pathologies that may affect balance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Acute Effects of Prolonged Walking on Pain, Balance and Posture in Individuals With Hallux Valgus Deformity
Hallux valgus is a progressive foot deformity characterized by lateral deviation of the great toe and medial displacement of the first metatarsal head. While pain is a common symptom among individuals with HV, alterations in plantar pressure distribution and impaired balance are also frequently observed. These symptoms and biomechanical changes can negatively impact posture and gait mechanics. The aim of this study is to investigate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity.
Read the detailed description
Hallux valgus is a progressive foot deformity commonly seen in adults. Patients typically report pain, most prominently in the first metatarsophalangeal joint, which is often exacerbated by weight-bearing activities such as walking. Due to the deformity, alterations in plantar pressure distribution occur, which in turn affect plantar sensory input and postural control. This may lead to decreased postural stability, impaired balance, and compromised control during walking. HV is also thought to accelerate biomechanical changes that negatively impact gait patterns. The aim of this study is to evaluate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity. A total of 32 participants, including individuals with HV and healthy controls, will be included in the study. All participants will walk on a treadmill for 60 minutes. Assessments will be conducted at three time points: before walking, immediately after walking, and 20 minutes post-walking.
- Conditions
- Hallux Valgus
- Being tested
- Prolonged walking
- Medical subject headings
- Hallux Valgus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged walkingOther
walking on a treadmill for 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| Hallux Valgus Group | Experimental | Individuals with hallux valgus deformity Receives: Other: Prolonged walking |
| Control Group | Other | Healthy controls Receives: Other: Prolonged walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Pain intensity will be evaluated with visual analog scale (VAS). Patients will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means the worst pain.
Measured: Baseline, immediately after intervention, 20 minutes after intervention
Pressure pain threshold
It will be measured with algometer. Higher values indicate a higher perceived pain threshold.
Measured: Baseline, immediately after intervention, 20 minutes after intervention
Single-leg stance test
The single leg stability will be assessed by using Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability.
Measured: Baseline, immediately after intervention, 20 minutes after intervention
Postural Assessment
Posture will be assessed using mobile application. It marks and measures angles at the ear, shoulder, anterior superior iliac spine (ASIS), knee, and ankle alignment to identify any pathological deviations or asymmetries.
Measured: Baseline, immediately after intervention, 20 minutes after intervention
Gait analysis
Gait analysis will be performed using mobile application. Subjects are asked to walk at their normal walking speed over a 10-meter surface, and measurements are taken using video recording and evaluated using the software. The assessment records right and left step lengths, double step length, stride width, and walking speed.
Measured: Baseline, immediately after intervention, 20 minutes after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hallux ValgusStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Alpay, Bezmialem Vakif University
- Investigators
- Ozgur Serbest, Pt, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177768
- Sponsor's protocol ID
- KA25-2
- Status last verified
- Sep 2025
- First submitted
- 10 Sep 2025
- Last updated
- 17 Sep 2025
- 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Prolonged Walking on Pain, Balance and Posture in Individuals With Hallux Valgus Deformity
- ClinicalTrials.gov ID
- NCT07177768
- Acronym / sponsor ID
- KA25-2
- Conditions
- Hallux Valgus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 17 Sep 2025 (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.
Hallux valgus is a progressive foot deformity characterized by lateral deviation of the great toe and medial displacement of the first metatarsal head. While pain is a common symptom among individuals with HV, alterations in plantar pressure distribution and impaired balance are also frequently observed. These symptoms and biomechanical changes can negatively impact posture and gait mechanics. The aim of this study is to investigate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity.
Detailed description
Hallux valgus is a progressive foot deformity commonly seen in adults. Patients typically report pain, most prominently in the first metatarsophalangeal joint, which is often exacerbated by weight-bearing activities such as walking. Due to the deformity, alterations in plantar pressure distribution occur, which in turn affect plantar sensory input and postural control. This may lead to decreased postural stability, impaired balance, and compromised control during walking. HV is also thought to accelerate biomechanical changes that negatively impact gait patterns. The aim of this study is to evaluate the acute effects of prolonged walking on pain, balance, posture, and gait in individuals with hallux valgus deformity. A total of 32 participants, including individuals with HV and healthy controls, will be included in the study. All participants will walk on a treadmill for 60 minutes. Assessments will be conducted at three time points: before walking, immediately after walking, and 20 minutes post-walking.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hallux Valgus Group | Experimental | Other: Prolonged walkingIndividuals with hallux valgus deformity |
| Control Group | Other | Other: Prolonged walkingHealthy controls |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Individuals aged between 18 and 55 years
- Being diagnosed with hallux valgus
- Individuals aged between 18 and 55 years
- Classified as grade A according to the Manchester Scale
- Being a volunteer
Key exclusion criteria (4 listed)
- History of previous foot or ankle surgery
- Having a systemic diseases
- Having a neurological disorders
- Having a vestibular pathologies that may affect balance
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 |
|---|---|---|
| Prolonged walkingwalking on a treadmill for 60 minutes | Other | Control Group, Hallux Valgus Group |
Primary outcome
Pain intensity
Time frame: Baseline, immediately after intervention, 20 minutes after intervention
Pain intensity will be evaluated with visual analog scale (VAS). Patients will be asked to mark the intensity of the pain they feel on a 10 cm line, where "0" means no pain and "10" means the worst pain.
Pressure pain threshold
Time frame: Baseline, immediately after intervention, 20 minutes after intervention
It will be measured with algometer. Higher values indicate a higher perceived pain threshold.
Single-leg stance test
Time frame: Baseline, immediately after intervention, 20 minutes after intervention
The single leg stability will be assessed by using Biodex Balance System® (Biodex Medical Systems, Inc. USA). Low values of the stability index indicate better balance and stability.
Postural Assessment
Time frame: Baseline, immediately after intervention, 20 minutes after intervention
Posture will be assessed using mobile application. It marks and measures angles at the ear, shoulder, anterior superior iliac spine (ASIS), knee, and ankle alignment to identify any pathological deviations or asymmetries.
Gait analysis
Time frame: Baseline, immediately after intervention, 20 minutes after intervention
Gait analysis will be performed using mobile application. Subjects are asked to walk at their normal walking speed over a 10-meter surface, and measurements are taken using video recording and evaluated using the software. The assessment records right and left step lengths, double step length, stride width, and walking speed.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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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.
Ozgur Serbest, Pt principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged walking in people with Hallux Valgus, run by Bezmialem Vakif 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 7 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: opening soon, as of the sponsor's last update on 17 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Alpay, PhD (+902124012600 ext. 4638, kalpay@bezmialem.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Baseline, immediately after intervention, 20 minutes after intervention). The study lists 5 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 17 Sep 2025.