- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07630805
Telerehabilitation vs. Conventional PT for Patellofemoral Pain Syndrome
Comparative Effects of Hybrid Telerehabilitation, Telerehabilitation and Conventional Physical Therapy in Treating Patients With Patellofemoral Pain Syndrome
연구 개요
상세 설명
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Giza, 이집트
- Egypt
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants must have a prior clinical diagnosis of PFPS made by an orthopedic physician, which was then confirmed and verified by the principal investigator through physical therapy assessment. The diagnosis is characterized by anterior or retropatellar knee pain aggravated by at least one activity that loads the patellofemoral joint during weight bearing, such as stair climbing, squatting, running, or prolonged sitting.
- Participants aged between 18 and 35 years.
- Participants with BMI ≤ 25 kg/m² to ensure inclusion of individuals within a normal weight range.
- Insidious onset of anterior knee pain with a duration greater than 12 weeks.
- Experienced a minimum pain level of 3/10 on a visual analogue scale (VAS) during activity within the previous week.
Exclusion Criteria:
Participants meeting any of the following conditions will be excluded from the study:
- Individuals with previous knee surgery, fracture, ligament reconstruction, patellar dislocation, osteoarthritis, meniscal injuries, inflammatory joint disease, or other conditions that may mimic or contribute to anterior knee pain.
- Participants with neurological, cardiovascular, or systemic musculoskeletal disorders that may affect gait, strength, or exercise tolerance
- Pregnant women will be excluded due to potential alterations in joint biomechanics and safety considerations during exercise interventions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Hybrid Telerehabilitation
Participants allocated to the Hybrid Telerehabilitation group will receive a combination of face to-face and remotely supervised exercise sessions over the 6-week intervention period. Face-to-face sessions will be used for comprehensive movement assessment, hands-on instruction of new exercises, verification of correct technique, and progression of exercise intensity and resistance. Remotely supervised sessions will be conducted using a secure video-conferencing platform (e.g., Zoom), allowing real-time visual monitoring of exercise execution and provision of verbal and visual feedback by the therapist. Camera positioning guidelines will be provided to ensure adequate visualization of frontal and sagittal plane lower-limb alignment during exercises, particularly during closed-chain and functional tasks. |
All three groups (Hybrid Telerehabilitation, Pure Telerehabilitation, and Conventional Physical Therapy) followed identical exercise progressions over 6 weeks (3 sessions/week, 18 sessions total) targeting proximal hip and knee strengthening.
Exercise dosage, intensity, and progression remained standardized across delivery modes to isolate rehabilitation method effects.
The exercise program will progress through three phases to allow gradual restoration of strength, control, and functional ability.
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실험적: Telerehabilitation
Participants in the Telerehabilitation group will complete all 18 exercise sessions (3 sessions per week for 6 weeks) remotely without attending in-person clinic visits.
All sessions will be supervised synchronously by the same physical therapist using a real-time video-conferencing platform (e.g., Zoom).
Before the start of the intervention, participants will receive standardized instructions regarding camera placement, exercise space setup, and safety considerations to ensure accurate observation of movement quality during training sessions.
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All three groups (Hybrid Telerehabilitation, Pure Telerehabilitation, and Conventional Physical Therapy) followed identical exercise progressions over 6 weeks (3 sessions/week, 18 sessions total) targeting proximal hip and knee strengthening.
Exercise dosage, intensity, and progression remained standardized across delivery modes to isolate rehabilitation method effects.
The exercise program will progress through three phases to allow gradual restoration of strength, control, and functional ability.
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실험적: Conventional Physical Therapy
Participants assigned to the Conventional Physical Therapy group will receive all 18 exercise sessions through traditional face-to-face supervised treatment at the outpatient physical therapy clinic.
Sessions will be conducted three times per week for six consecutive weeks, under the direct supervision of a licensed physical therapist.
This model represents standard clinical practice for the management of patellofemoral pain syndrome and allows continuous monitoring of exercise performance, immediate correction of faulty movement patterns, and direct verbal feedback during training.
During each session, the therapist will ensure correct execution of both hip- and knee focused exercises, reinforce appropriate lower-limb alignment, and adjust exercise intensity and resistance according to predefined progression criteria.
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All three groups (Hybrid Telerehabilitation, Pure Telerehabilitation, and Conventional Physical Therapy) followed identical exercise progressions over 6 weeks (3 sessions/week, 18 sessions total) targeting proximal hip and knee strengthening.
Exercise dosage, intensity, and progression remained standardized across delivery modes to isolate rehabilitation method effects.
The exercise program will progress through three phases to allow gradual restoration of strength, control, and functional ability.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Pain intensity
기간: up to 6 weeks
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The pain intensity was assessed using the Visual Analogue Scale (VAS), where patients rated their pain at rest and during movement over the previous week on a 0-10 cm scale, with 0 indicating no pain and 10 representing unbearable pain.
Pain scores were recorded before and after the intervention.
Interpretation of clinical relevance often goes beyond statistical significance, and the minimal clinically important difference (MCID) for pain intensity on the VAS has been investigated in a range of musculoskeletal conditions
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up to 6 weeks
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Knee function assessment
기간: up to 6 weeks
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Knee function will be evaluated using the Kujala Anterior Knee Pain Scale (AKPS), which is a condition-specific, self-administered questionnaire designed to assess pain severity and functional limitations associated with patellofemoral pain syndrome.
Participants will be asked to complete the questionnaire independently by responding to 13 weighted items that address symptoms and difficulty during daily and sports-related activities that load the patellofemoral joint, including walking, running, stair climbing, squatting, jumping, and prolonged sitting with the knee flexed
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up to 6 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Dynamic knee valgus assessment
기간: up to 6 weeks
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A two-dimensional video analysis measured the knee valgus/varus frontal-plane projection angle (FPPA) during the Single-Legged Drop Jump test following established methodology
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up to 6 weeks
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Quadriceps muscle strength assessment
기간: up to 6 weeks
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Quadriceps muscle strength will be assessed using the peak torque normalized to body weight (peak torque/body weight, Nm/kg ×100), which will be recorded during maximal knee extension at 60° of knee flexion
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up to 6 weeks
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- P.T.REC/012/006508
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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