Responsiveness And Minimal Clinically Important Difference Of Navicular Height Drop Test With Plantar Fasciitis

NCT07055698 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall23/832
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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

  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).

  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.

  12 Months

Interventions

The Navicular Height Drop (NHD) test DIAGNOSTIC_TEST

Evaluating the test's responsiveness and minimal clinically important difference (MCID) can help determine its clinical relevance in monitoring treatment outcomes.

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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.).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Omer Hospital & Cardiac Center

Lahore, Punjab Province, Pakistan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 9, 2025
• Study Start: March 17, 2025
• Primary Completion: September 1, 2025
• Study Completion: February 28, 2026
• Last Updated: July 9, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)