- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07664332
Immediate Effects of Plantar Fascia Release Combined With Foot Exercises on FMS Subscores in Young Adults With Pes Planus (FMS-PP)
Immediate Efeects of Plantar Facia Release Combined With Foot Exercises on Functional Movement Screen Subscores in Young Adults With Pes Planus: A Randomized Crossover Study
This randomized crossover clinical study aims to investigate the immediate effects of plantar fascia release combined with foot exercises on Functional Movement Screen sub-scores in physically active young adults with pes planus.
Participants aged 18-35 years with pes planus, determined by the Navicular Drop Test, will complete two different intervention protocols in a randomized order. Protocol A will include foot-core exercises combined with plantar fascia stretching. Protocol B will include the same foot-core exercises and plantar fascia stretching, with the addition of plantar fascia myofascial release. Each participant will receive both interventions on separate sessions, with a 24-hour wash-out period between sessions.
Functional movement quality will be assessed using two Functional Movement Screen subtests: Deep Squat and Hurdle Step. These tests will be performed before and after each intervention session to evaluate acute changes in movement performance.
The main hypothesis of the study is that plantar fascia myofascial release combined with foot-core exercises and plantar fascia stretching will produce greater immediate improvements in Functional Movement Screen Deep Squat and Hurdle Step scores compared with foot-core exercises and plantar fascia stretching alone.
Study Overview
Status
Conditions
Detailed Description
This study is planned as a randomized crossover interventional clinical study designed to evaluate the acute effects of plantar fascia release combined with foot exercises on functional movement quality in young adults with pes planus.
Pes planus is associated with reduced medial longitudinal arch support and excessive pronation, which may influence lower extremity alignment, load transfer, postural control, and functional movement patterns. Foot-core exercises aim to activate and strengthen the intrinsic muscles of the foot that support the medial longitudinal arch. Plantar fascia stretching and myofascial release may improve the flexibility and mechanical properties of the plantar fascia and may contribute to improved ankle and lower extremity movement capacity. Therefore, combining active foot stabilization exercises with plantar fascia interventions may provide an immediate effect on movement quality.
The study will include physically active young adults aged 18-35 years with pes planus. Pes planus will be determined using the Navicular Drop Test. Physical activity level will be assessed using the International Physical Activity Questionnaire. After eligibility screening and written informed consent, participants will complete two different intervention protocols in a randomized order.
The crossover design will allow each participant to receive both intervention protocols and serve as his or her own control. A 24-hour wash-out period will be provided between the two intervention sessions to minimize possible carry-over effects. In each session, Functional Movement Screen subtests will be assessed before the intervention. The assigned intervention protocol will then be applied, followed by a one-hour waiting period. After this waiting period, the Functional Movement Screen subtests will be repeated to determine the immediate effect of the intervention.
Protocol A will consist of foot-core exercises combined with plantar fascia stretching. The foot-core exercise program will include short foot exercise, towel curl, toe spread, great toe extension, and reverse tandem walking. Plantar fascia stretching will be performed using a plantar fascia-specific stretching technique.
Protocol B will consist of the same foot-core exercises and plantar fascia stretching, with the addition of plantar fascia myofascial release. Myofascial release will be applied manually along the plantar fascia, from the calcaneal region toward the metatarsal heads, with controlled pressure and within the participant's tolerance.
Functional movement quality will be evaluated using the Deep Squat and Hurdle Step subtests of the Functional Movement Screen. These tests were selected because they reflect lower extremity mobility, stability, balance, and movement control, which may be influenced by foot posture and plantar fascia mobility.
The primary aim of the study is to compare the immediate effects of the two intervention protocols on Functional Movement Screen Deep Squat and Hurdle Step scores. The study hypothesis is that the protocol including plantar fascia myofascial release, plantar fascia stretching, and foot-core exercises will result in greater immediate improvement in Functional Movement Screen sub-scores compared with foot-core exercises and plantar fascia stretching alone.
All assessments and interventions will be performed face-to-face in a clinical/laboratory setting by trained physiotherapists. Procedures will be conducted according to standardized instructions, and participant safety and comfort will be monitored throughout the study.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Emre S Atalay, PhD
- Phone Number: +90 544 405 18 24
- Email: emreserdar.atalay@sbu.edu.tr
Study Contact Backup
- Name: Büşra ERYİĞİT, PT
- Phone Number: 905396570877
- Email: busraeryigit00@gmail.com
Study Locations
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Osmaniye
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Antakya, Osmaniye, Turkey (Türkiye), 06018
- University of Healt Sciences, Gülhane Faculty ofHealth Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being between 18 and 35 years of age
- Voluntarily agreeing to participate in the study and providing written informed consent
- Having pes planus according to the Navicular Drop Test result
- Having the cognitive ability to understand and perform the Functional Movement Screen (FMS) test instructions
- Being classified as sufficiently physically active according to the International Physical Activity Questionnaire (IPAQ), defined as at least 1500 MET-min/week of vigorous-intensity activity or at least 3000 MET-min/week of moderate-intensity activity
- Having no history of lower extremity surgery within the last 6 months
- Having no history of lower extremity injury/disability within the last 6 months
- Agreeing to complete the study protocol over two days
Exclusion Criteria:
- Having a history of ankle sprain, especially recurrent ankle sprains
- Presence of hallux valgus deformity
- Presence of hammer toe deformity
- Presence of generalized ligamentous laxity
- Having a history of systemic disease, such as rheumatic, neurological, or metabolic disorders
- Presence of ongoing lower extremity pain
- Having any orthopedic or neurological condition that may prevent the safe performance of the Functional Movement Screen tests
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Protocol A
Participants will receive Protocol A, which includes foot core exercises combined with plantar fascia stretching.
In the randomized crossover design, Protocol A may be administered either in the first session or in the second session, depending on the randomized intervention order.
FMS Deep Squat and Hurdle Step scores will be assessed before and after the intervention session.
|
Protocol A consists of foot core exercises combined with plantar fascia stretching.
Foot core exercises include short foot exercise, towel curl, toe spread, great toe extension, and reverse tandem walking.
Plantar fascia stretching will be performed using a plantar fascia-specific stretching technique.
This protocol may be administered in either the first or second session according to the randomized crossover order.
|
|
Experimental: Protocol B
Participants will receive Protocol B, which includes foot core exercises combined with plantar fascia stretching and plantar fascia myofascial release.
In the randomized crossover design, Protocol B may be administered either in the first session or in the second session, depending on the randomized intervention order.
FMS Deep Squat and Hurdle Step scores will be assessed before and after the intervention session.
|
Protocol B consists of all components of Protocol A, including foot core exercises and plantar fascia stretching, with the addition of plantar fascia myofascial release.
Myofascial release will be applied manually along the plantar fascia from the calcaneal region toward the metatarsal heads, with pressure adjusted according to participant tolerance.
This protocol may be administered in either the first or second session according to the randomized crossover order.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Functional Movement Screen Hurdle Step Score
Time Frame: Before intervention and 1 hour after intervention in each session
|
The Hurdle Step subtest of the Functional Movement Screen will be used to assess single-leg balance, hip stability, knee control, and ankle stability.
The score ranges from 0 to 3, with higher scores indicating better movement quality.
The change from pre-intervention to post-intervention will be compared between protocols.
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Before intervention and 1 hour after intervention in each session
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Change in Functional Movement Screen Deep Squat Score
Time Frame: Before intervention and 1 hour after intervention in each session
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The Deep Squat subtest of the Functional Movement Screen will be used to assess functional movement quality involving the lower extremity, trunk, shoulder, hip, knee, and ankle.
The score ranges from 0 to 3, with higher scores indicating better movement quality.
The change from pre-intervention to post-intervention will be compared between protocols
|
Before intervention and 1 hour after intervention in each session
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Richman ED, Tyo BM, Nicks CR. Combined Effects of Self-Myofascial Release and Dynamic Stretching on Range of Motion, Jump, Sprint, and Agility Performance. J Strength Cond Res. 2019 Jul;33(7):1795-1803. doi: 10.1519/JSC.0000000000002676.
- Sulowska I, Oleksy L, Mika A, Bylina D, Soltan J. The Influence of Plantar Short Foot Muscle Exercises on Foot Posture and Fundamental Movement Patterns in Long-Distance Runners, a Non-Randomized, Non-Blinded Clinical Trial. PLoS One. 2016 Jun 23;11(6):e0157917. doi: 10.1371/journal.pone.0157917. eCollection 2016.
- Soni J, Sawant S, Shah S. Efficacy of Core Stability Exercises and Intrinsic Foot Training on Patients With Flat Foot: A Comparative Study. Cureus. 2025 Oct 29;17(10):e95659. doi: 10.7759/cureus.95659. eCollection 2025 Oct.
Study record dates
Study Major Dates
Study Start (Estimated)
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
- Talipes
- Musculoskeletal Diseases
- Musculoskeletal Abnormalities
- Congenital Abnormalities
- Lower Extremity Deformities, Congenital
- Limb Deformities, Congenital
- Foot Deformities
- Foot Deformities, Acquired
- Foot Deformities, Congenital
- Congenital, Hereditary, and Neonatal Diseases and Abnormalities
- Flatfoot
- Therapeutics
- Complementary Therapies
- Physical Therapy Modalities
- Rehabilitation
- Therapy, Soft Tissue
- Musculoskeletal Manipulations
- Massage
- Myofascial Release Therapy
Other Study ID Numbers
- 2026-095
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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