Foot DeformitiesNCT05656014
The Relationship of the Medial Longitudinal Arch Height With Clinical Features of Knee Osteoarthritis
An observational study of Foot Deformities and Pes Planus, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the relationships between the medial longitudinal arch (MLA) height of the foot and clinical and radiological characteristics of knee osteoarthritis in adult patients 50 aged and over. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Foot Deformities, Pes Planus, Pes Cavus
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Dec 2022to 3 Jun 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients 50 years of age or older diagnosed with osteoarthritis of one or both knees according to the American College of Rheumatology criteria
Who may be able to join
- Being 50 years old or older
- Having a diagnosis of knee osteoarthritis according to the American College of Rheumatology
Who cannot join
- History of fracture or orthopaedic surgery involving lower limbs
- Presence of neurological condition resulting in lower limb sensorimotor deficit
- Having another inflammatory rheumatological disease
- Having a malignant tumour with bone metastasis
- Having lower limb oedema, lymphedema, skin and soft tissue loss that will prevent the evaluation of foot morphology (arch height index)
- Severe neuropsychiatric disease or condition that interferes with communication
- Having therapeutic injection into the knee joint in the last 3 months
- Presence of any major trauma that aggravated knee pain in the last 6 weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi University Hospital, Department of Physical Medicine and Rehabilitation
Ankara, 06560
About this study
Official title: The Relationship of Medial Longitudinal Arch Height With Pain, Disease Severity and Knee Joint Alignment in Patients With Knee Osteoarthritis
The goal of this observational study is to investigate the relationships between the medial longitudinal arch (MLA) height of the foot and clinical and radiological characteristics of knee osteoarthritis in adult patients 50 aged and over. The main questions it aims to answer are:
- Is there any relationship between knee pain and disability in knee osteoarthritis and MLA height?
- Is there any relationship between the radiologic severity of knee osteoarthritis and MLA height?
- Is there any relationship between knee joint alignment in knee osteoarthritis and MLA height?
Read the detailed description
Differences in hind and midfoot structures, including the medial longitudinal arch, affect lower limb alignment and biomechanics. However, the causal relationship between knee joint problems and foot deformities is controversial. Knee osteoarthritis, a common orthopaedic condition in the elderly population, tends to distort the lower limb alignment by narrowing the tibiofemoral joint space asymmetrically. Therefore, knee varus and medial longitudinal arch deformities may change gait biomechanics on knee osteoarthritis. However, there is insufficient evidence on the relationship between variation in foot posture and disease severity, knee varus deformity, knee pain and disability in knee osteoarthritis. In this study, investigators will examine the lower extremity alignment and osteoarthritis severity in terms of MLA height in adults with knee osteoarthritis.
The study sample will be formed by the simple random sampling method from adult patients with knee osteoarthritis who will be admitted to our clinics and outpatient clinics with knee pain. It was planned to include 93 participants to be able to detect the two-way correlation between the knee WOMAC score and the arch height index with an effect size of 0.3, a power of 90%, and a 5% margin of error.
Initially, demographic data, including age, gender, body mass index (BMI), limb dominance, and time from knee pain onset of participants, will be recorded. For both knees goniometric measurement of knee passive range of motion (ROM), visual analogue scale (VAS) for pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be applied. Kellgren/Lawrence stages, mechanical, and anatomical tibiofemoral angles for knee joints will be obtained from lower limb length X-ray. MLA height index measurement will be performed by an investigator blinded to the patient's clinical condition. According to the results of descriptive statistics, the relationship between MLA height measurement results (arch height index and arch height flexibility) and Kellgren-Lawrence stage, VAS, WOMAC and tibiofemoral angles will be examined by correlation analysis. In case of significant correlation, regression analyses for Kellgren-Lawrence, VAS and WOMAC scores as dependent variables will be applied.
- Conditions
- Foot Deformities, Pes Planus, Pes Cavus, Knee Osteoarthritis, Knee Pain Chronic, Disability Physical
- Keywords
- Medial longitudinal arch, Arch height index, Knee osteoarthritis, Knee pain, Foot, Lower limb alignment
- Medical subject headings
- Foot Deformities, Flatfoot, Talipes Cavus, Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with knee osteoarthritis | Adult patients 50 years of age or older diagnosed with knee osteoarthritis according to American College of Rheumatology criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arch Height Index while bipedal standing
The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while bipedal standing. Normal values have been reported to be approximately 0.338 ± 0.031 to 0.343 ± 0.033 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.
Measured: Within the three days of clinical evaluation
Arch Height Index while sitting
The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while sitting with feet calmly on the ground. Normal values have been reported to be approximately 0.355 ± 0.031 to 0.369 ± 0.034 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.
Measured: Within the three days of clinical evaluation
Arch Height Flexibility
Arch Height Flexibility will be calculated by the [(arch height while sitting - arch height while standing) / 0.4 x body weight] x 100 (m/kN) formula. Higher values represent the more flexible medial longitudinal arch structure.
Measured: Within the three days of clinical evaluation
Kellgren Lawrence stage of knee osteoarthritis
It is a radiological grading of knee osteoarthritis with a value between 0 to 4. Medial and lateral tibiofemoral compartments are evaluated on weight-bearing anteroposterior knee radiograph in terms of joint space narrowing, subchondral periosteal sclerosis, subchondral cyst and osteophytic formations. Zero means no radiographic evidence of osteoarthritis, while 4 indicates advanced knee osteoarthritis.
Measured: Within the three days of clinical evaluation
Anatomical tibiofemoral angle
It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the anatomical axes of the femur and tibia. The normal value of the anatomical tibiofemoral angle is between 4 to 6 degrees of valgus. A higher positive value will indicate more valgus posture of the knee, while lower or negative values will be related to varus deformity.
Measured: Within the three days of clinical evaluation
Mechanical tibiofemoral angle
It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the lines drawn from the femoral head to the femoral intercondylar notch and from the tibial interspinous point to the tibial mid-plafond. The mechanical tibiofemoral angle is approximately 1-1.5 degrees of varus for a knee in normal alignment. In this study, to ensure consistency with the anatomical tibiofemoral angle values, the direction of angulation will be noted as a positive or negative value for the valgus or varus, respectively.
Measured: Within the three days of clinical evaluation
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for both knees
WOMAC is a specific, valid and reliable tool for measuring disability in the knee and hip osteoarthritis. It includes 24 questions under three sub-domains: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=none, 1=mild, 2=moderate, 3=severe, and 4=extreme. The total score is defined by the [(sum of the scores)/96]x100 formula and ranges from 0 to 100. Higher scores indicate increased disability due to more severe pain, stiffness and impaired physical function.
Measured: Within the three days of clinical evaluation
Visual analogous scale score for knee pain
Participants are asked to mark the severity of their right and left knee pain in the past month on a 100 mm horizontal line; where point zero represents "no pain" and point 100 represents "the most severe pain possible". The result is noted in millimetres by measuring the distance from the "zero" to the marked point. Increasing values represent higher pain intensity.
Measured: Within the three days of clinical evaluation
Secondary outcomes (2)
Knee range of motions
Flexion and extension range of motions will be measured using a goniometer regarding the neutral zero method for both knees. Decreased values represent a limited range of motion of the knee joint.
Measured: Within the day of clinical evaluation
Time after pain onset (weeks)
The duration of knee pain leading to hospital admission will be noted.
Measured: Within the day of clinical evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start7 Dec 2022
- Primary completion3 Jun 2024
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Foot DeformitiesStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Levent Karataş, Gazi University
- Investigators
- Levent Karataş, MD, Principal investigator, Gazi University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656014
- Sponsor's protocol ID
- Knee osteoarthritis and AHI
- Status last verified
- Aug 2024
- First submitted
- 9 Dec 2022
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
PubMed 3741515Williams DS, McClay IS. Measurements used to characterize the foot and the medial longitudinal arch: reliability and validity. Phys Ther. 2000 Sep;80(9):864-71.
PubMed 10960934Weimar WH, Shroyer JF. Arch height index normative values of college-aged women using the arch height index measurement system. J Am Podiatr Med Assoc. 2013 May-Jun;103(3):213-7. doi: 10.7547/1030213.
PubMed 23697727Hillstrom HJ, Song J, Kraszewski AP, Hafer JF, Mootanah R, Dufour AB, Chow BS, Deland JT 3rd. Foot type biomechanics part 1: structure and function of the asymptomatic foot. Gait Posture. 2013 Mar;37(3):445-51. doi: 10.1016/j.gaitpost.2012.09.007. Epub 2012 Oct 26.
PubMed 23107625Zifchock RA, Theriot C, Hillstrom HJ, Song J, Neary M. The Relationship Between Arch Height and Arch FlexibilityA Proposed Arch Flexibility Classification System for the Description of Multidimensional Foot Structure. J Am Podiatr Med Assoc. 2017 Mar;107(2):119-123. doi: 10.7547/15-051. Epub 2017 Feb 15.
PubMed 28198638Karatas L, Vuralli D, Gunendi Z. The effect of medial longitudinal arch height and medial longitudinal arch support insoles on postural balance in perimenopausal women. Turk J Med Sci. 2019 Jun 18;49(3):755-760. doi: 10.3906/sag-1808-39.
PubMed 31023006Marques Luis N, Varatojo R. Radiological assessment of lower limb alignment. EFORT Open Rev. 2021 Jun 28;6(6):487-494. doi: 10.1302/2058-5241.6.210015. eCollection 2021 Jun.
PubMed 34267938Moreland JR, Bassett LW, Hanker GJ. Radiographic analysis of the axial alignment of the lower extremity. J Bone Joint Surg Am. 1987 Jun;69(5):745-9.
PubMed 3597474
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Medial Longitudinal Arch Height With Pain, Disease Severity and Knee Joint Alignment in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05656014
- Acronym / sponsor ID
- Knee osteoarthritis and AHI
- Conditions
- Foot Deformities, Pes Planus, Pes Cavus, Knee Osteoarthritis, Knee Pain Chronic, Disability Physical
- Keywords
- Medial longitudinal arch, Arch height index, Knee osteoarthritis, Knee pain, Foot, Lower limb alignment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 3 Jun 2024 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 19 Dec 2022 (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.
The goal of this observational study is to investigate the relationships between the medial longitudinal arch (MLA) height of the foot and clinical and radiological characteristics of knee osteoarthritis in adult patients 50 aged and over. The main questions it aims to answer are:
- Is there any relationship between knee pain and disability in knee osteoarthritis and MLA height?
- Is there any relationship between the radiologic severity of knee osteoarthritis and MLA height?
- Is there any relationship between knee joint alignment in knee osteoarthritis and MLA height?
Detailed description
Differences in hind and midfoot structures, including the medial longitudinal arch, affect lower limb alignment and biomechanics. However, the causal relationship between knee joint problems and foot deformities is controversial. Knee osteoarthritis, a common orthopaedic condition in the elderly population, tends to distort the lower limb alignment by narrowing the tibiofemoral joint space asymmetrically. Therefore, knee varus and medial longitudinal arch deformities may change gait biomechanics on knee osteoarthritis. However, there is insufficient evidence on the relationship between variation in foot posture and disease severity, knee varus deformity, knee pain and disability in knee osteoarthritis. In this study, investigators will examine the lower extremity alignment and osteoarthritis severity in terms of MLA height in adults with knee osteoarthritis.
The study sample will be formed by the simple random sampling method from adult patients with knee osteoarthritis who will be admitted to our clinics and outpatient clinics with knee pain. It was planned to include 93 participants to be able to detect the two-way correlation between the knee WOMAC score and the arch height index with an effect size of 0.3, a power of 90%, and a 5% margin of error.
Initially, demographic data, including age, gender, body mass index (BMI), limb dominance, and time from knee pain onset of participants, will be recorded. For both knees goniometric measurement of knee passive range of motion (ROM), visual analogue scale (VAS) for pain and Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be applied. Kellgren/Lawrence stages, mechanical, and anatomical tibiofemoral angles for knee joints will be obtained from lower limb length X-ray. MLA height index measurement will be performed by an investigator blinded to the patient's clinical condition. According to the results of descriptive statistics, the relationship between MLA height measurement results (arch height index and arch height flexibility) and Kellgren-Lawrence stage, VAS, WOMAC and tibiofemoral angles will be examined by correlation analysis. In case of significant correlation, regression analyses for Kellgren-Lawrence, VAS and WOMAC scores as dependent variables will be applied.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with knee osteoarthritis | – | –Adult patients 50 years of age or older diagnosed with knee osteoarthritis according to American College of Rheumatology criteria |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 50 years of age or older diagnosed with osteoarthritis of one or both knees according to the American College of Rheumatology criteria
Key inclusion criteria (2 listed)
- Being 50 years old or older
- Having a diagnosis of knee osteoarthritis according to the American College of Rheumatology
Key exclusion criteria (8 listed)
- History of fracture or orthopaedic surgery involving lower limbs
- Presence of neurological condition resulting in lower limb sensorimotor deficit
- Having another inflammatory rheumatological disease
- Having a malignant tumour with bone metastasis
- Having lower limb oedema, lymphedema, skin and soft tissue loss that will prevent the evaluation of foot morphology (arch height index)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arch Height Index while bipedal standing
Time frame: Within the three days of clinical evaluation
The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while bipedal standing. Normal values have been reported to be approximately 0.338 ± 0.031 to 0.343 ± 0.033 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.
Arch Height Index while sitting
Time frame: Within the three days of clinical evaluation
The ratio of the dorsum height of the foot (measured in the middle of the total foot length) to truncated foot length, while sitting with feet calmly on the ground. Normal values have been reported to be approximately 0.355 ± 0.031 to 0.369 ± 0.034 in college-aged women. Higher values represent the increased medial longitudinal arch height of the foot (e.g. pes cavus) while lower values are related to pes planus.
Arch Height Flexibility
Time frame: Within the three days of clinical evaluation
Arch Height Flexibility will be calculated by the [(arch height while sitting - arch height while standing) / 0.4 x body weight] x 100 (m/kN) formula. Higher values represent the more flexible medial longitudinal arch structure.
Kellgren Lawrence stage of knee osteoarthritis
Time frame: Within the three days of clinical evaluation
It is a radiological grading of knee osteoarthritis with a value between 0 to 4. Medial and lateral tibiofemoral compartments are evaluated on weight-bearing anteroposterior knee radiograph in terms of joint space narrowing, subchondral periosteal sclerosis, subchondral cyst and osteophytic formations. Zero means no radiographic evidence of osteoarthritis, while 4 indicates advanced knee osteoarthritis.
Anatomical tibiofemoral angle
Time frame: Within the three days of clinical evaluation
It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the anatomical axes of the femur and tibia. The normal value of the anatomical tibiofemoral angle is between 4 to 6 degrees of valgus. A higher positive value will indicate more valgus posture of the knee, while lower or negative values will be related to varus deformity.
Mechanical tibiofemoral angle
Time frame: Within the three days of clinical evaluation
It is the angle, measured on a weight-bearing, full-length anteroposterior lower limb radiograph, between the lines drawn from the femoral head to the femoral intercondylar notch and from the tibial interspinous point to the tibial mid-plafond. The mechanical tibiofemoral angle is approximately 1-1.5 degrees of varus for a knee in normal alignment. In this study, to ensure consistency with the anatomical tibiofemoral angle values, the direction of angulation will be noted as a positive or negative value for the valgus or varus, respectively.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores for both knees
Time frame: Within the three days of clinical evaluation
WOMAC is a specific, valid and reliable tool for measuring disability in the knee and hip osteoarthritis. It includes 24 questions under three sub-domains: pain, stiffness, and physical function. Each question is scored on a Likert scale as 0=none, 1=mild, 2=moderate, 3=severe, and 4=extreme. The total score is defined by the [(sum of the scores)/96]x100 formula and ranges from 0 to 100. Higher scores indicate increased disability due to more severe pain, stiffness and impaired physical function.
Visual analogous scale score for knee pain
Time frame: Within the three days of clinical evaluation
Participants are asked to mark the severity of their right and left knee pain in the past month on a 100 mm horizontal line; where point zero represents "no pain" and point 100 represents "the most severe pain possible". The result is noted in millimetres by measuring the distance from the "zero" to the marked point. Increasing values represent higher pain intensity.
2 secondary outcomes
Knee range of motions
Time frame: Within the day of clinical evaluation
Time after pain onset (weeks)
Time frame: Within the day of clinical evaluation
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 12 Aug 2024.
- Background: PubMed 3741515Altman R, Asch E, Bloch D, Bole G, Borenstein D, Brandt K, Christy W, Cooke TD, Greenwald R, Hochberg M, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Arthritis Rheum. 1986 Aug;29(8):1039-49. doi: 10.1002/art.1780290816.
- Background: PubMed 10960934Williams DS, McClay IS. Measurements used to characterize the foot and the medial longitudinal arch: reliability and validity. Phys Ther. 2000 Sep;80(9):864-71.
- Background: PubMed 23697727Weimar WH, Shroyer JF. Arch height index normative values of college-aged women using the arch height index measurement system. J Am Podiatr Med Assoc. 2013 May-Jun;103(3):213-7. doi: 10.7547/1030213.
- Background: PubMed 23107625Hillstrom HJ, Song J, Kraszewski AP, Hafer JF, Mootanah R, Dufour AB, Chow BS, Deland JT 3rd. Foot type biomechanics part 1: structure and function of the asymptomatic foot. Gait Posture. 2013 Mar;37(3):445-51. doi: 10.1016/j.gaitpost.2012.09.007. Epub 2012 Oct 26.
- Background: PubMed 28198638Zifchock RA, Theriot C, Hillstrom HJ, Song J, Neary M. The Relationship Between Arch Height and Arch FlexibilityA Proposed Arch Flexibility Classification System for the Description of Multidimensional Foot Structure. J Am Podiatr Med Assoc. 2017 Mar;107(2):119-123. doi: 10.7547/15-051. Epub 2017 Feb 15.
- Background: PubMed 31023006Karatas L, Vuralli D, Gunendi Z. The effect of medial longitudinal arch height and medial longitudinal arch support insoles on postural balance in perimenopausal women. Turk J Med Sci. 2019 Jun 18;49(3):755-760. doi: 10.3906/sag-1808-39.
- Background: PubMed 34267938Marques Luis N, Varatojo R. Radiological assessment of lower limb alignment. EFORT Open Rev. 2021 Jun 28;6(6):487-494. doi: 10.1302/2058-5241.6.210015. eCollection 2021 Jun.
- Background: PubMed 3597474Moreland JR, Bassett LW, Hanker GJ. Radiographic analysis of the axial alignment of the lower extremity. J Bone Joint Surg Am. 1987 Jun;69(5):745-9.
- 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.
Levent Karataş, MD principal investigator
Gazi University Faculty of Medicine
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 Foot Deformities and Pes Planus, 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 2 inclusion and 8 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 12 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?
Arch Height Index while bipedal standing (time frame: Within the three days of clinical evaluation). The study lists 8 primary outcomes in all. 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 NCT05656014, which also lists 8 linked publications.
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 12 Aug 2024.