NCT07628218

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
0mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Feb 2026Aug 2026

Study Start

First participant enrolled

February 12, 2026

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 4, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2026

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

6 months

First QC Date

May 29, 2026

Last Update Submit

June 3, 2026

Conditions

Keywords

Exercise TherapyPatient EducationNon-Inferiority Trial

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months

    Baseline, 1 month, and 3 months after randomization

  • Change in Foot Function Index Pain Subscale Score From Baseline to 1 and 3 Months

    Baseline, 1 month, and 3 months after randomization

  • Change in Foot Function Index Disability Subscale Score From Baseline to 1 and 3 Months

    Baseline, 1 month, and 3 months after randomization

Study Arms (2)

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.

Behavioral: Physician-Led Face-to-Face Exercise Instruction

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.

Behavioral: Video-Based Exercise Instruction

Interventions

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.

Physician-Led Face-to-Face 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.

Video-Based Exercise Instruction

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Balikesir Ataturk City Hospital

Balıkesir, +90(543)673-3113, Turkey (Türkiye)

RECRUITING

Study Officials

  • gunes SARIKAYA

    Balikesir Ataturk City Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedics and Traumatology Specialist

Study Record Dates

First Submitted

May 29, 2026

First Posted

June 4, 2026

Study Start

February 12, 2026

Primary Completion (Estimated)

August 12, 2026

Study Completion (Estimated)

August 12, 2026

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.

Locations