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Planter FasciitisNCT06142123

Effects Of Ankle Mobility Exercises And Heel Drop Training In Planter Fasciitis

A study testing 3-D Ankle Mobility Exercises(A) and Eccentric Heel Drop Training(B) in people with Planter Fasciitis and Eccentric Heel Drop Training, run by Riphah International University at 1 site in Pakistan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
What is being tested?
3-D Ankle Mobility Exercises(A) and Eccentric Heel Drop Training(B)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 sitePakistan
Study dates
1 Sep 2023to 5 Jan 2024
Phase
Interventional
Are there results?
None posted in the registry

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 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Pakistan1 site, 1 recruiting
  • Boston Physiotherapy Clinic

    Lahore, Punjab Province

    Fariha Shah, +92 322 6951214, Farhia.b.shah@gmail.com

    Muniba Afzal, +92 336 8302839, munibaafzal00@gmail.com

    Recruiting

Other trials in Pakistan

About this study

Official title: 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.

Read the detailed description

Planter fasciitis is a common cause of heel pain in adults with a major incidence seen in women. Planter fasciitis is frequently seen among athletes playing various sports. However, it is more prevalent in professional runners(1). A list of intrinsic risk factors are associated with this condition which can be linked with individual's anatomy, physiology, their mobility \& function or it can be linked with degenerative changes(2). 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). Individuals experiencing PF employ compensatory techniques to lessen pain experienced at the plantar fascia's origin(4). They assume antalgic gait pattern, increasing support on the lateral and anterior faces of the foot to reduce the amount of time their heels are in contact with the ground in return affecting upright posture within the base of support due to these compensations, which alter joint position perception and muscle activations resulting in static and dynamic imbalances(5).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(6). To increase coordination, joint range of motion, muscular strength, and eccentric control associated with PF, these exercises can be paired with the combined isotonic (CI) approach. This allows the concentric, eccentric, and stabilizing contractions of agonists to be performed without relaxation(7). 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(8). The heel drop exercise modify Lateral and medial gastrocnemius architectural conditions which has been implicated in patients with PF, resulting in injury prevention(9).The purpose of our study is to determine a comparable exercise regime for planter fasciitis among athletes which can easily be incorporated as an essential component of their routine training program in order to prevent the occurrence of planter fasciitis as well as improve the prognosis of already affected athletes. Planter fasciitis is a common condition prevalent among female athletes, however, frequently ignored as well. The groundwork of this research will help creating awareness among female athletes and provide them with a significant solution to help with the pain which causes a less efficient exercise performance. Very few data is available to support the use of 3-d Ankle mobility exercises. Our investigation will also explore the generic effects of commonly unknown 3-d Ankle Mobility exercises with combined isotonic technique which are based on the D2 diagonal PNF patterns

Being tested
3-D Ankle Mobility Exercises(A), Eccentric Heel Drop Training(B)
Keywords
Eccentric heel drop training, 3-D ankle mobility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3-D Ankle Mobility Exercises(A)Other

    The techniques will be first performed in prone lying against the resistance of the therapist and then in crook lying.

    1. The participant will perform the D2 extension pattern (Planter-flexion-supination inversion-toe flexion) using the CI technique in the prone position according to the resistance of therapist.
    2. The participant will perform the D2 flexion pattern (Dorsi-flexion-pronation eversion-toe extension) using CI technique in the prone position according to the resistance of therapist.
    3. The participant will perform the D2 extension pattern (Planter-flexion-supination inversion-toe flexion) using the CI technique in the crook-lying position according to the resistance of therapist.
    4. The participant will perform the D2 flexion pattern (Dorsi-flexion-pronation eversion-toe extension) using CI technique in the crook-lying position according to the resistance of therapist.
  • Eccentric Heel Drop Training(B)Other

    : Group B will be treated with Eccentric Heel Drop Training. It will comprise of following exercises (14).

    1. Eccentric loading exercises of calf muscles.
    2. Conventional physiotherapy treatment including Ultrasound Plantar fascia stretching Calf muscle stretching Intrinsic muscles strengthening
Study groups in NCT06142123
Study groupRoleWhat they receive
Group AExperimentalGroup 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
Receives: Other: 3-D Ankle Mobility Exercises(A)
Group BExperimentalGroup 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
Receives: Other: Eccentric Heel Drop Training(B)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Foot and Ankle Ability Measure (FAAM)

    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

    Measured: pre and 4 weeks post interventional

  2. Numeric Pain Rating Scale

    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"

    Measured: pre and 4 weeks post interventional

Secondary outcomes (1)
  1. The VISA-A questionnaire: An index of the severity of Achilles tendinopathy: The VISA-A questionnaire: An index of the severity of Achilles tendinopathy

    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)

    Measured: pre and 4 weeks post interventional

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2023
  2. Study start1 Sep 2023
  3. Primary completion20 Dec 2023 (estimated)
  4. Study completion5 Jan 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06142123
Sponsor's protocol ID
REC/RCR&AHS/23/0433
Status last verified
Nov 2023
First submitted
15 Nov 2023
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trojian T, Tucker AK. Plantar Fasciitis. Am Fam Physician. 2019 Jun 15;99(12):744-750.

    PubMed 31194492
  • 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.

    PubMed 28717618
  • 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.

    PubMed 31810057
  • 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.

    PubMed 24716522
  • 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.

    PubMed 35816306

Questions about this trial

What is this clinical trial studying?

A study testing 3-D Ankle Mobility Exercises(A) and Eccentric Heel Drop Training(B) in people with Planter Fasciitis and Eccentric Heel Drop Training, run by Riphah International 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Malia Younas (+92 325 8292286, Maliayounas62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Foot and Ankle Ability Measure (FAAM) (time frame: pre and 4 weeks post interventional). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06142123, which also lists 5 linked publications.

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 21 Nov 2023.

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