Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025/12/147 | Other Identifier | Balıkesir Atatürk City Hospital Clinical Research Ethics Committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician-Led Face-to-Face Exercise Instruction | Active Comparator | 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. |
|
| Video-Based Exercise Instruction | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physician-Led Face-to-Face Exercise Instruction | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Foot Function Index Total/Index Score From Baseline to 3 Months | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gunes SARIKAYA | Contact | 05436733113 | gunessarikaya05@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| gunes SARIKAYA | Balikesir Ataturk City Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Balikesir Ataturk City Hospital | Recruiting | Balıkesir | +90(543)673-3113 | Turkey (Türkiye) |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will be randomized in a 1:1 ratio to either physician-led face-to-face exercise instruction or standardized video-based exercise instruction. The exercise content will be identical in both groups; only the method of instruction will differ.
Not provided
Not provided
Because of the nature of the intervention, participants and treating physicians cannot be masked to group allocation. To reduce bias, standardized forms and predefined follow-up assessments will be used, and group codes will be used during statistical analysis.
Not provided
|
| Video-Based Exercise Instruction | Behavioral | 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. |
|
| Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months | 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 | 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 |