Effect of Selected Rehabilitation Program in Patients With Plantar Fasciitis

July 19, 2025 updated by: Mohamed Ramadan Ibraheem Ramadan, Horus University

Effect of Selected Rehabilitation Program on Pain, Function, and Plantar Fascia Thickness in Patients With Plantar Fasciitis

This study will be done to investigate the effect of the selected rehabilitation program for PF on plantar fascia thickness, clinical outcomes such as pain, foot function, dorsiflexion ROM and pressure pain threshold and alignment such as rearfoot eversion angle and foot posture index in patients with PF.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Plantar fasciitis (PF), which constitutes approximately 15% of all foot disorders, is the most prevalent cause of heel pain. It is a long-term degenerative process that is impacted by subtalar pronation and pes planus. One million US patients saw primary care physicians with PF between 1995 and 2000. There is not enough data to determine the best physical therapy management techniques for individuals with heel pain, despite the existence of multiple successful treatment approaches. this study investigated at how a mechanically based rehabilitation program affected patients with PF in terms of foot alignment, plantar fascia thickness, pain, pressure pain threshold, ROM and foot function. The approach included strengthening the plantar intrinsic muscles of the foot, plantar fascia specific stretching and Achilles tendon stretching, and passively correcting the pathomechanics of the foot by low dye tapping and high load resistance exercise for Achilles tendon and windlass mechanism

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Damietta, Egypt, 34518
        • Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
      • Damietta, Egypt
        • out-patient clinic, faculty of physical therapy, Horus university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Plantar medial heel pain: most noticeable with initial steps after a period of inactivity, but also worse following prolonged weight-bearing
  • Pain with palpation of the proximal insertion of the plantar fascia
  • Positive windlass test
  • flat foot posture utilizing the foot posture index
  • age range from 40 to 60 years

Exclusion Criteria:

  • tarsal tunnel syndrome
  • atrophy of the fat pad.
  • diabetic patients or patients with rheumatoid arthritis
  • corticosteroid injection over the last sex months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: selected rehabilitation program
involves 24 patients and will be given the selected rehabilitation program involving (self-stretching exercise, mobilization of the ankle and subtalar, rigid tape and unilateral heel raising exercise 3 times per week for 8 weeks.
Other: stretching exercises
stretching exercises of the plantar fascia, gastrocnemius and soleus
Other: rigid tape
low-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch
Other: mobilization
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
Other: strengthening exercise
strengthening exercise of the plantar intrinsic muscles using short foot exercise and strengthening of the Achilles tendon and windlass mechanism using unilateral heel raise exercises
Experimental: traditional program
involves 24 patients and will be given the traditional program involving (self-stretching exercise, mobilization of the ankle and subtalar, plantar fascial release and ultrasonic therapy 3 times per week for 8 weeks.
Other: stretching exercises
stretching exercises of the plantar fascia, gastrocnemius and soleus
Other: mobilization
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
Device: ultrasound
therapeutic ultrasound upon the most painful point on the medial calcaneal tubercle. The parameters involved a pulsed mode (duty cycle 50%) using an intensity of 1.5 W/cm2 and a 1 MHz of frequency for 5 minutes
Other: myofascial release
deep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assessing the change in pain intensity
Time Frame: At baseline and following 8 weeks
VAS is typically composed of a 100 mm horizontal line attached to two opposed labels, the left end marked "no pain" and the right end marked "worst possible pain. Patients were marked a score on the scale by a vertical line that exactly refer to their pain
At baseline and following 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing the change in foot posture
Time Frame: At baseline and following 8 weeks
using the foot posture index. It is a clinical measure of foot posture, either supinated or pronated, using 6 items for assessment of foot and scoring of each item from -2 to +2
At baseline and following 8 weeks
Assessing the change in foot function
Time Frame: At baseline and following 8 weeks
The Arabic version of the foot function index (FFI) is a widely used self-reporting measure used to assess the impact of foot pathology on pain, disability, and activity limitation. It is a reliable and sensitive outcome measure for patients with foot and ankle disorders. The FFI's subscale scores range from 0% to 100%, with higher scores indicating lower function and a poorer quality of life.
At baseline and following 8 weeks
Assessing the change in plantar fascia thickness
Time Frame: At baseline and following 8 weeks
using the ultrasound, participants were positioned in a prone position with relaxed arms and legs, and measurements were taken with the ankle joint in neutral or slightly dorsi-flexion. Electro-conductive gel was applied to the US transducer and plantar surface of foot before imaging. The transducer was placed longitudinally on the calcaneus surface to obtain a clear image of the plantar fascia.
At baseline and following 8 weeks
Assessing the change in rear foot angle
Time Frame: At baseline and following 8 weeks
using kinovea motion analysis software, the rearfoot (calcaneus) angle is measured as the angle between the bisection of the lower one-third of the leg and the bisection of the calcaneus. The MLA is classified as: normal arch 2-8°, low arch ≥ 8.1° and high arch ≤ 1.9.
At baseline and following 8 weeks
Assessing the change in range of motion
Time Frame: At baseline and following 8 weeks
The bubble inclinometer is used to measure the angle of the tibia relative to the floor during active ankle dorsiflexion, while the patient lunges forward with their heel on the ground and knee in line with the second toe.
At baseline and following 8 weeks
Assessing the change in pressure pain threshold
Time Frame: At baseline and following 8 weeks
the pressure algometer is utilized to measure the pressure pain threshold (PPT), The patient lay supine, in a relaxed position, with his feet hanging over the edge of the bed with no pressure on the heel. PPT is measured by laying the patient supine with feet hanging over the bed, without pressure on the heel. PPT is determined by applying pressure to the skin until the patient experiences pain.
At baseline and following 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Horus University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mohamed Ramadan Ibraheem, Assistant lecturer, Horus University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mohamed PHD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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