- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: gunes SARIKAYA
- Telefonnummer: 05436733113
- E-post: gunessarikaya05@hotmail.com
Studieorter
-
-
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Balıkesir, Turkiet (Türkiye), +90(543)673-3113
- Rekrytering
- Balikesir Ataturk City Hospital
-
Kontakt:
- gunes SARIKAYA
- Telefonnummer: 05436733113
- E-post: gunessarikaya05@hotmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv 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.
|
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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Foot Function Index Total/Index Score From Baseline to 3 Months
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months
Tidsram: 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.
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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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: gunes SARIKAYA, Balikesir Ataturk City Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- PF-RCT-NI-2026-001
- 2025/12/147 (Annan identifierare: Balıkesir Atatürk City Hospital Clinical Research Ethics Committee)
Plan för individuella deltagardata (IPD)
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