- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06456944
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
Completed
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
Interventional
Enrollment (Actual)
48
Phase
- 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 Locations
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-
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Damietta, Egypt, 34518
- Outpatient clinic, Faculty of Physical Therapy, Horus University, Egypt
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Damietta, Egypt
- out-patient clinic, faculty of physical therapy, Horus university
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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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
stretching exercises of the plantar fascia, gastrocnemius and soleus
low-dye tapping will be done to provide mechanical correction to plantar fascia and medial longitudinal arch
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
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.
|
stretching exercises of the plantar fascia, gastrocnemius and soleus
mobilization techniques for the talocrural joint in weight bearing and non-bearing positions and subtalar joint
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
deep tissue release of the plantar fascia and flexor hallucis longus in a stretched position of the plantar fascia
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What is the study measuring?
Primary Outcome Measures
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
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.
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At baseline and following 8 weeks
|
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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.
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At baseline and following 8 weeks
|
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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
|
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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.
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At baseline and following 8 weeks
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Assessing the change in pressure pain threshold
Time Frame: At baseline and following 8 weeks
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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.
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At baseline and following 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
June 15, 2024
Primary Completion (Actual)
March 15, 2025
Study Completion (Actual)
April 15, 2025
Study Registration Dates
First Submitted
June 8, 2024
First Submitted That Met QC Criteria
June 8, 2024
First Posted (Actual)
June 13, 2024
Study Record Updates
Last Update Posted (Actual)
July 22, 2025
Last Update Submitted That Met QC Criteria
July 19, 2025
Last Verified
July 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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