Plantar FascitisNCT07055698
Responsiveness And Minimal Clinically Important Difference Of Navicular Height Drop Test With Plantar Fasciitis
An observational study of Plantar Fascitis, run by Superior University at 1 site in Pakistan.
Trial summary
Plantar fasciitis is a common musculoskeletal condition characterized by heel pain and impaired foot function, often linked to abnormal foot biomechanics. The Navicular Height Drop (NHD) test is a non-invasive tool used to assess dynamic foot posture by measuring changes in the medial longitudinal arch. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Plantar Fascitis
- What is being tested?
- The Navicular Height Drop (NHD) test
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 17 Mar 2025to 28 Feb 2026
- Phase
- Observational
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: A Perspective Cohort Study. This study aims to establish the responsiveness and MCID of the NHD test, enabling its effective use as a clinical tool for monitoring plantar fasciitis outcomes. By identifying clinically meaningful changes
Who may be able to join
- Patients with a clinical diagnosis of Plantar Fasciitis confirmed by Orthopedic presence of heel pain, particularly at the plantar aspect of the heel, for more than 3 months.
- Pain on palpation of the medial calcaneal tubercle.
- Positive Windlass test.
- Adults aged 25-60 years.
- Patients should be able to perform the Navicular Drop Test without any other concurrent - lower limb pathology that might interfere with the test (e.g., Achilles tendonitis, knee osteoarthritis, etc.).
Who cannot join
- Patients who have undergone any surgical intervention in the foot or ankle (e.g., plantar fascia release, foot fracture surgery).
- Recent history (within 6 weeks) of acute foot or ankle injury (e.g., fractures, sprains).
- Conditions such as rheumatoid arthritis, diabetes, neuropathy, peripheral vascular disease, or any neurological disorders affecting the lower limbs that could confound the results.
- Patients with other foot conditions like flatfoot deformity, bunion deformity, Morton's neuroma, severe hallux valgus, or any other condition affecting foot biomechanics that might alter the Navicular Drop Test results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Responsiveness And Minimal Clinically Important Difference Of Navicular Height Drop Test In Patients With Plantar Fasciitis
Plantar fasciitis is a common musculoskeletal condition characterized by heel pain and impaired foot function, often linked to abnormal foot biomechanics. The Navicular Height Drop (NHD) test is a non-invasive tool used to assess dynamic foot posture by measuring changes in the medial longitudinal arch. Evaluating the test's responsiveness and minimal clinically important difference (MCID) can help determine its clinical relevance in monitoring treatment outcomes. Study objective to evaluate the responsiveness and determine the minimal clinically important difference (MCID) of the Navicular Height Drop (NHD) test in patients with plantar fasciitis.
- Conditions
- Plantar Fascitis
- Being tested
- The Navicular Height Drop (NHD) test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Navicular Height Drop (NHD) testDiagnostic test
Evaluating the test's responsiveness and minimal clinically important difference (MCID) can help determine its clinical relevance in monitoring treatment outcomes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Navicular Height Drop Test (NHDT)
This test measures the change in the position of the navicular bone during weight-bearing, helping to assess foot arch collapse and the impact of abnormal foot biomechanics, which is crucial in conditions like plantar fasciitis
Measured: 12 Months
GLOBAL RATING OF CHANGE (GRC)
The GRC scale is a simple tool where patients rate their overall improvement after treatment. It is often used to establish the MCID by comparing patients' subjective perceptions of improvement with changes in objective measures like NHDT. The responses are usually rated on a Likert-type scale, which might look like this:+7: Very Much Improved ,+6: Much Improved ,+5: Improved ,+4: Minimally Improved ,+3: No Change ,+2: Minimally Worse ,+1: Worse ,0: Very Much Worse(31).
Measured: 12 Months
Foot Function Index
A self-reported questionnaire assessing pain, disability, and activity limitation in individuals with foot disorders, commonly used to assess the functional impact of plantar fasciitis.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2025
- Study start17 Mar 2025
- Primary completion1 Sep 2025 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plantar FascitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07055698
- Sponsor's protocol ID
- MSRSW/Batch-Fall23/832
- Status last verified
- Jun 2025
- First submitted
- 28 Jun 2025
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Responsiveness And Minimal Clinically Important Difference Of Navicular Height Drop Test In Patients With Plantar Fasciitis
- ClinicalTrials.gov ID
- NCT07055698
- Acronym / sponsor ID
- MSRSW/Batch-Fall23/832
- Conditions
- Plantar Fascitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 9 Jul 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.
Plantar fasciitis is a common musculoskeletal condition characterized by heel pain and impaired foot function, often linked to abnormal foot biomechanics. The Navicular Height Drop (NHD) test is a non-invasive tool used to assess dynamic foot posture by measuring changes in the medial longitudinal arch. Evaluating the test's responsiveness and minimal clinically important difference (MCID) can help determine its clinical relevance in monitoring treatment outcomes. Study objective to evaluate the responsiveness and determine the minimal clinically important difference (MCID) of the Navicular Height Drop (NHD) test in patients with plantar fasciitis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- A Perspective Cohort Study. This study aims to establish the responsiveness and MCID of the NHD test, enabling its effective use as a clinical tool for monitoring plantar fasciitis outcomes. By identifying clinically meaningful changes
Key inclusion criteria (5 listed)
- Patients with a clinical diagnosis of Plantar Fasciitis confirmed by Orthopedic presence of heel pain, particularly at the plantar aspect of the heel, for more than 3 months.
- Pain on palpation of the medial calcaneal tubercle.
- Positive Windlass test.
- Adults aged 25-60 years.
- Patients should be able to perform the Navicular Drop Test without any other concurrent - lower limb pathology that might interfere with the test (e.g., Achilles tendonitis, knee osteoarthritis, etc.).
Key exclusion criteria (4 listed)
- Patients who have undergone any surgical intervention in the foot or ankle (e.g., plantar fascia release, foot fracture surgery).
- Recent history (within 6 weeks) of acute foot or ankle injury (e.g., fractures, sprains).
- Conditions such as rheumatoid arthritis, diabetes, neuropathy, peripheral vascular disease, or any neurological disorders affecting the lower limbs that could confound the results.
- Patients with other foot conditions like flatfoot deformity, bunion deformity, Morton's neuroma, severe hallux valgus, or any other condition affecting foot biomechanics that might alter the Navicular Drop Test results.
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 |
|---|---|---|
| The Navicular Height Drop (NHD) testEvaluating the test's responsiveness and minimal clinically important difference (MCID) can help determine its clinical relevance in monitoring treatment outcomes. | Diagnostic test | – |
Primary outcome
Navicular Height Drop Test (NHDT)
Time frame: 12 Months
This test measures the change in the position of the navicular bone during weight-bearing, helping to assess foot arch collapse and the impact of abnormal foot biomechanics, which is crucial in conditions like plantar fasciitis
GLOBAL RATING OF CHANGE (GRC)
Time frame: 12 Months
The GRC scale is a simple tool where patients rate their overall improvement after treatment. It is often used to establish the MCID by comparing patients' subjective perceptions of improvement with changes in objective measures like NHDT. The responses are usually rated on a Likert-type scale, which might look like this:+7: Very Much Improved ,+6: Much Improved ,+5: Improved ,+4: Minimally Improved ,+3: No Change ,+2: Minimally Worse ,+1: Worse ,0: Very Much Worse(31).
Foot Function Index
Time frame: 12 Months
A self-reported questionnaire assessing pain, disability, and activity limitation in individuals with foot disorders, commonly used to assess the functional impact of plantar fasciitis.
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 9 Jul 2025.
- 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 Plantar Fascitis, run by Superior University at 1 site in Pakistan.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 9 Jul 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 Pakistan. 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?
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?
Navicular Height Drop Test (NHDT) (time frame: 12 Months). The study lists 3 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 9 Jul 2025.