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Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis

27 augustus 2026 bijgewerkt door: güneş sarıkaya, Balikesir Ataturk City Hospital

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

This prospective, single-center, two-arm, parallel-group randomized non-inferiority trial will compare physician-led face-to-face exercise instruction with standardized video-based exercise instruction in adults with plantar fasciitis. Participants will be randomized in a 1:1 ratio to receive either face-to-face exercise training by an orthopedic physician or access to a standardized exercise video via QR code/web link. The exercise content will be identical in both groups; only the method of instruction will differ. The primary outcome will be the change in the Foot Function Index total/index score from baseline to 3 months. Secondary outcomes will include pain score, Foot Function Index subscales, exercise knowledge, exercise adherence, education time, video viewing status, additional treatment requirement, and patient satisfaction.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

300

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: 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.
Gedragsmatig: Physician-Led Face-to-Face Exercise Instruction
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.
Experimenteel: 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.
Gedragsmatig: Video-Based Exercise Instruction
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Foot Function Index Total/Index Score From Baseline to 3 Months
Tijdsspanne: Baseline and 3 months after randomization
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.
Baseline and 3 months after randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months
Tijdsspanne: Baseline, 1 month, and 3 months after randomization
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.
Baseline, 1 month, and 3 months after randomization
Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months
Tijdsspanne: Baseline, 1 month, and 3 months after randomization
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.
Baseline, 1 month, and 3 months after randomization
Change in Foot Function Index Disability Subscale Score From Baseline to 1 and 3 Months
Tijdsspanne: Baseline, 1 month, and 3 months after randomization
The disability subscale of the Foot Function Index will be used to assess foot-related functional disability. Higher scores indicate greater disability.
Baseline, 1 month, and 3 months after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Balikesir Ataturk City Hospital

Onderzoekers

  • Hoofdonderzoeker: gunes SARIKAYA, Balikesir Ataturk City Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 februari 2026

Primaire voltooiing (Geschat)

12 november 2026

Studie voltooiing (Geschat)

12 november 2026

Studieregistratiedata

Eerst ingediend

29 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 juni 2026

Eerst geplaatst (Werkelijk)

4 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

28 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

27 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • PF-RCT-NI-2026-001
  • 2025/12/147 (Andere identificatie: Balıkesir Atatürk City Hospital Clinical Research Ethics Committee)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be publicly shared because the ethics approval and informed consent do not include public sharing of participant-level data. De-identified aggregate study results will be reported in scientific presentations and publications.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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