- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06142123
Effects Of Ankle Mobility Exercises And Heel Drop Training In Planter Fasciitis
Comparative Effects Of 3-D Ankle Mobility Exercises And Eccentric Heel Drop Training In Female Athletes With Planter Fasciitis
Planter fasciitis is a common cause of heel pain in adults. Planter fasciitis is frequently seen among athletes playing various sports. However, it is more prevalent in professional runner. The Biomechanical stresses including the increase in the intensity, frequency or the time frame of weight bearing activities that subject athlete's feet to continuous impact loads, surfaces with inadequate cushioning or improper shoe replacement are some of extrinsic risk factors associated with planter fasciitis.3-D ankle mobility exercises are improvised for treatment of plantar fasciitis, these comprise D2 diagonal PNF leg patterns, comprising of flexion-abduction-internal rotation and extension-adduction-external rotation. Heel drop exercise training is another useful intervention used for treating PF; the protocol consists transferring their body weight onto the forefoot of their dominant legs while slightly flexing their ankles. To get back to baseline, the non-dominant leg is given more weight, and the dominant leg's knee was remained fully extended to maintain higher gastrocnemius activation.
A Randomized clinical trial will be conducted at Pakistan Sports Board and Boston Physiotherapy Clinic Lahore through consecutive sampling technique on patients which will be allocated through opaque sealed enveloped into Group A and Group B. Group A will be treated with 3-D ankle mobility exercises and Group B will be treated with eccentric heel drop training. Outcome measures tools will be conducted through NPRS, Foot and Ankle Ability Measure (FAAM) and The VISA-A questionnaire: An index of the severity of Achilles tendinopathy after four weeks. Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Malia Younas
- Phone Number: +92 325 8292286
- Email: Maliayounas62@gmail.com
Study Contact Backup
- Name: Amna shahid
- Phone Number: +92 334 4512823
- Email: amna.shahid@riphah.edu.pk
Study Locations
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Punjab
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Lahore, Punjab, Pakistan
- Recruiting
- Boston Physiotherapy Clinic
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Contact:
- Fariha Shah
- Phone Number: +92 322 6951214
- Email: Farhia.b.shah@gmail.com
-
Contact:
- Muniba Afzal
- Phone Number: +92 336 8302839
- Email: munibaafzal00@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Clinical diagnosis based on the clinical presentation Pain on palpation along the proximal plantar fascia with or without radiographic evidence of a plantar calcaneal bone spur Pain reporting of minimum of 2 on NPRS Athletes with 18 years to 35 years of age Chronic plantar fasciitis of more than 3 months. Female athletes playing more than 2 years in sports including runners, Soccer players, cricket players, cyclist, body builders.
Exclusion Criteria:
Chronic pain syndrome or other foot pains Peripheral vascular disease that results in rest pain or intermittent claudication or venous stasis ulceration Calcaneal stress fracture or show evidence of a foreign body or tumor of the affected heel as viewed radio graphically Pregnant females Previously suffered a rupture or surgery of the plantar fascia within the 5 years preceding participation in the investigation Existing or prior osteomyelitis of the involved calcaneus
Study Plan
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: Group A
Group A will be treated with 3-D Ankle Mobility Exercises with combined isotonic (agonist) technique at ankle joint. Two diagonal (D2) Flexion-Extension patterns from the PNF leg patterns will be used. Both the techniques will be first performed in prone lying against the resistance of the therapist and then in crook lying. The patients will receive Intervention consisting 14 sets (7 sets for each 3-D extension-flexion [1 set (1 min) = exercise 30sec + rest 30 sec]) performed for 15 minutes thrice per week for four weeks |
The techniques will be first performed in prone lying against the resistance of the therapist and then in crook lying.
|
|
Experimental: Group B
Group B will be treated with Eccentric Heel Drop Training and Conventional physiotherapy treatment All patients will be treated once daily with 10 sets of 15 repetitions with a frequency of 2sec per repetitions and an interval of 30 sec between each set of Eccentric Heel drop training, 4 days a week for four weeks
|
: Group B will be treated with Eccentric Heel Drop Training. It will comprise of following exercises (14).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Foot and Ankle Ability Measure (FAAM)
Time Frame: pre and 4 weeks post interventional
|
The Foot and Ankle Ability Measures Scale is a collection of self-administered questionnaire comprising 29 questions that is split down into two subscales: activities of daily living (21 questions) and sports population (8 questions)(15).
With an ICC value of 0.89 for Activities of Daily Living (ADL) and 0.87 for the Sports subscale, it has a significant level of reliability
|
pre and 4 weeks post interventional
|
|
Numeric Pain Rating Scale
Time Frame: pre and 4 weeks post interventional
|
Patient level of pain will be assessed using this scale. This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" |
pre and 4 weeks post interventional
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The VISA-A questionnaire: An index of the severity of Achilles tendinopathy: The VISA-A questionnaire: An index of the severity of Achilles tendinopathy
Time Frame: pre and 4 weeks post interventional
|
The VISA-A is a self-administered questionnaire that aims to evaluate the clinical severity for patients with chronic Achilles tendinopathy and associated biomechanical abnormalities. It is an easily self-administered questionnaire that evaluates symptoms and their effect on physical activity. The three clinically significant patient-relevant domains of pain, function, and activity are assessed using the VISA-A questionnaire. In patients with AT, the VISA-A questionnaire exhibits strong test-retest reliability and has been validated (construct validity) |
pre and 4 weeks post interventional
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Muniba Afzal, Riphah International University
Publications and helpful links
General Publications
- Trojian T, Tucker AK. Plantar Fasciitis. Am Fam Physician. 2019 Jun 15;99(12):744-750.
- Petraglia F, Ramazzina I, Costantino C. Plantar fasciitis in athletes: diagnostic and treatment strategies. A systematic review. Muscles Ligaments Tendons J. 2017 May 10;7(1):107-118. doi: 10.11138/mltj/2017.7.1.107. eCollection 2017 Jan-Mar.
- Alonso-Fernandez D, Taboada-Iglesias Y, Garcia-Remeseiro T, Gutierrez-Sanchez A. Effects of the Functional Heel Drop Exercise on the Muscle Architecture of the Gastrocnemius. J Sport Rehabil. 2020 Nov 1;29(8):1053-1059. doi: 10.1123/jsr.2019-0150. Epub 2019 Dec 6.
- Konrad A, Gad M, Tilp M. Effect of PNF stretching training on the properties of human muscle and tendon structures. Scand J Med Sci Sports. 2015 Jun;25(3):346-55. doi: 10.1111/sms.12228. Epub 2014 Apr 10.
- Johannsen F, Olesen JL, Ohlenschlager TF, Lundgaard-Nielsen M, Cullum CK, Jakobsen AS, Rathleff MS, Magnusson PS, Kjaer M. Effect of Ultrasonography-Guided Corticosteroid Injection vs Placebo Added to Exercise Therapy for Achilles Tendinopathy: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2219661. doi: 10.1001/jamanetworkopen.2022.19661.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0433
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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