Video-Based Versus Physician-Led Exercise Training for Plantar Fasciitis
2026년 6월 3일 업데이트: 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.
연구 개요
상태
모병
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
300
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: gunes SARIKAYA
- 전화번호: 05436733113
- 이메일: gunessarikaya05@hotmail.com
연구 장소
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Balıkesir, 터키 (Türkiye), +90(543)673-3113
- 모병
- Balikesir Ataturk City Hospital
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연락하다:
- gunes SARIKAYA
- 전화번호: 05436733113
- 이메일: gunessarikaya05@hotmail.com
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Foot Function Index Total/Index Score From Baseline to 3 Months
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Numeric Rating Scale Pain Score From Baseline to 1 and 3 Months
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: gunes SARIKAYA, Balikesir Ataturk City Hospital
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2026년 2월 12일
기본 완료 (추정된)
2026년 8월 12일
연구 완료 (추정된)
2026년 8월 12일
연구 등록 날짜
최초 제출
2026년 5월 29일
QC 기준을 충족하는 최초 제출
2026년 6월 3일
처음 게시됨 (실제)
2026년 6월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- PF-RCT-NI-2026-001
- 2025/12/147 (기타 식별자: Balıkesir Atatürk City Hospital Clinical Research Ethics Committee)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
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아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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