- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07664332
Immediate Effects of Plantar Fascia Release Combined With Foot Exercises on FMS Subscores in Young Adults With Pes Planus (FMS-PP)
Immediate Effects of Plantar Fascia 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 washout 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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 their own control. A 24-hour washout period will be provided between the two intervention sessions to minimize possible carryover 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 subscores 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 subscores compared with foot-core exercises and plantar fascia stretching alone.
All assessments and interventions will be performed face to face in a clinical setting by trained physiotherapists. Procedures will be conducted according to standardized instructions, and participant safety and comfort will be monitored throughout the study.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Emre S Atalay, PhD
- Telefonní číslo: +90 544 405 18 24
- E-mail: emreserdar.atalay@sbu.edu.tr
Studijní záloha kontaktů
- Jméno: Büşra ERYİĞİT, PT
- Telefonní číslo: 905396570877
- E-mail: busraeryigit00@gmail.com
Studijní místa
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Ankara
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Ankara, Ankara, Turecko (Türkiye), 06018
- University of Healt Sciences, Gülhane Faculty ofHealth Sciences
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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 1,500 MET-min/week of vigorous-intensity activity or at least 3,000 MET-min/week of moderate-intensity activity
- Having no history of lower-extremity surgery within the previous 6 months
- Having no history of lower-extremity injury or disability within the previous 6 months
- Agreeing to complete the study protocol over two days
Exclusion Criteria:
- Having a history of ankle sprain, particularly 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Functional Movement Screen Hurdle Step Score
Časové okno: Before intervention and 1 hour after intervention in each session
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The Hurdle Step subtest of the Functional Movement Screen will be used to assess single-leg balance, hip stability, knee control, and ankle stability.
Scores 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
Časové okno: 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 extremities, trunk, shoulders, hips, knees, and ankles.
Scores range 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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Spolupracovníci a vyšetřovatelé
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Talipes
- Nemoci pohybového aparátu
- Muskuloskeletální abnormality
- Vrozené vady
- Deformace dolních končetin, vrozené
- Deformace končetin, vrozené
- Deformace chodidla
- Deformace chodidla, získané
- Deformace chodidla, vrozené
- Vrozené, dědičné a neonatální nemoci a abnormality
- Plochá noha
- Terapeutika
- Doplňkové terapie
- Modality fyzikální terapie
- Rehabilitace
- Terapie, měkká tkáň
- Muskuloskeletální manipulace
- Masáž
- Terapie myofasciální uvolňování
Další identifikační čísla studie
- 2026-095
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