- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07628218
Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
Clinical Effectiveness of Video-Based Exercise Training Compared With Physician-Led Face-to-Face Exercise Instruction in Patients With Plantar Fasciitis: A Randomized Non-Inferiority Trial
Przegląd badań
Status
Szczegółowy opis
Plantar fasciitis is a common cause of chronic plantar heel pain and may lead to functional limitation and reduced quality of life. Exercise education is an important component of conservative treatment; however, in busy outpatient settings, the time available for detailed face-to-face instruction may be limited. Standardized video-based education may provide a practical alternative by delivering the same exercise content in a reproducible format.
This study will evaluate whether video-based exercise instruction is non-inferior to physician-led face-to-face instruction in patients with plantar fasciitis. All participants will receive standard information about plantar fasciitis, load management, footwear recommendations, weight control, short-term analgesic or anti-inflammatory use when needed, and heel pad or insole support. The home exercise program will be identical in both groups and will include plantar fascia-specific stretching, gastrocnemius/soleus stretching, plantar fascia self-massage, gradual toe raises, and towel pull exercises.
Assessments will be performed at baseline, 1 month, and 3 months after randomization. Functional status will be assessed using the Foot Function Index, and pain will be measured using a 0-10 numerical rating scale. Exercise knowledge, adherence, education duration, video viewing behavior, additional treatment use, and satisfaction will also be recorded.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: gunes SARIKAYA
- Numer telefonu: 05436733113
- E-mail: gunessarikaya05@hotmail.com
Lokalizacje studiów
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Balıkesir, Turcja (Türkiye), +90(543)673-3113
- Rekrutacyjny
- Balikesir Ataturk City Hospital
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Kontakt:
- gunes SARIKAYA
- Numer telefonu: 05436733113
- E-mail: gunessarikaya05@hotmail.com
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 18 to 70 years
- Clinical diagnosis of plantar fasciitis
- Plantar heel pain lasting for at least 3 months
- Heel pain that is most prominent with the first steps in the morning or after rest
- Tenderness on palpation of the medial calcaneal tubercle
- Baseline heel pain score of 4 or higher on a 0-10 numerical rating scale
- Functional capacity to perform the prescribed exercises
- Access to a smartphone, tablet, or computer to view the exercise video
- Ability to provide written informed consent
Exclusion Criteria:
- Previous foot or ankle surgery on the affected side
- History of foot fracture, foot tumor, advanced neuropathy, Charcot arthropathy, or tarsal tunnel syndrome
- Corticosteroid injection, extracorporeal shock wave therapy, platelet-rich plasma injection, or other interventional treatment for plantar fasciitis within the last 6 months
- Inflammatory arthritis or systemic rheumatologic disease affecting the foot
- Severe knee or hip osteoarthritis limiting exercise performance
- Severe cognitive impairment preventing participation or completion of questionnaires
- Pregnancy
- Inability or unwillingness to comply with the study protocol
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: Physician-Led Face-to-Face Exercise Instruction
Participants in this arm will receive standard plantar fasciitis education and physician-led face-to-face instruction of the home exercise program.
The orthopedic physician will explain and demonstrate the exercises during the baseline visit.
The exercise program will include plantar fascia-specific stretching, gastrocnemius/soleus stretching, plantar fascia self-massage, gradual toe raises, and towel pull exercises.
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Face-to-face instruction and demonstration of a standardized home exercise program by an orthopedic physician.
The program includes plantar fascia-specific stretching, gastrocnemius/soleus stretching, plantar fascia self-massage, gradual toe raises, and towel pull exercises.
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Eksperymentalny: Video-Based Exercise Instruction
Participants in this arm will receive standard plantar fasciitis education and a QR code or web link providing access to a standardized exercise video prepared by the study team.
The video will not be watched in the outpatient clinic; participants will be instructed to perform the exercises at home by watching the video.
The exercise content, order, repetitions, and frequency will be identical to the physician-led group.
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Access to a standardized home exercise video prepared by the study team via QR code or web link.
Participants will be instructed to watch the video at home and perform the same exercise program used in the physician-led group.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Foot Function Index Total/Index Score From Baseline to 3 Months
Ramy czasowe: Baseline and 3 months after randomization
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The Foot Function Index total/index score is a patient-reported measure of foot pain, disability, and activity limitation, converted to a 0-100 score.
Higher scores indicate worse foot-related function.
The primary endpoint will be the change from baseline to 3 months, calculated as baseline FFI score minus 3-month FFI score; higher positive values indicate greater clinical improvement.
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Baseline and 3 months after randomization
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months
Ramy czasowe: Baseline, 1 month, and 3 months after randomization
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Heel pain while walking during the previous week will be assessed using an 11-point numerical rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates unbearable pain.
Change scores will be calculated from baseline to each follow-up visit.
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Baseline, 1 month, and 3 months after randomization
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Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months
Ramy czasowe: Baseline, 1 month, and 3 months after randomization
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The pain subscale of the Foot Function Index will be used to assess foot-related pain.
Scores will be converted according to the standard Foot Function Index scoring method; higher scores indicate worse pain.
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Baseline, 1 month, and 3 months after randomization
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Change in Foot Function Index Disability Subscale Score From Baseline to 1 and 3 Months
Ramy czasowe: Baseline, 1 month, and 3 months after randomization
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The disability subscale of the Foot Function Index will be used to assess foot-related functional disability.
Higher scores indicate greater disability.
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Baseline, 1 month, and 3 months after randomization
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: gunes SARIKAYA, Balikesir Ataturk City Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- PF-RCT-NI-2026-001
- 2025/12/147 (Inny identyfikator: Balıkesir Atatürk City Hospital Clinical Research Ethics Committee)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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