슬개대퇴 통증이 있는 러너를 위한 보행 재훈련
여성 러너의 슬개대퇴부 통증을 위한 보행 재훈련 중재: 무작위 대조 시험
Patellofemoral pain (PFP) is a common overuse injury in runners. Increased patellofemoral joint stress (PFJS) is an important biomechanical factor associated with PFP. Gait retraining, especially cadence modification, may reduce PFJS and improve symptoms, but evidence from randomized controlled trials remains limited. This study investigated whether wearable device-assisted gait retraining was more effective than education alone in reducing pain, improving function, and altering running biomechanics in female runners with PFP.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 장소
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Beijing, 중국
- Beijing Sport University
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Female, Age 18-45 years
- Unilateral/bilateral anterior knee pain > 4 weeks
- VAS pain ≥ 3/10 during running and ≥ 2 of the following: jumping, squatting, kneeling, stairs, prolonged sitting, or resisted knee extension
- Running ≥ 15 km per week
- Natural rearfoot striker
Exclusion Criteria:
- Acute trauma, history of patellar dislocation, meniscal/chondral lesions
- Prior knee surgery or injection in past 12 months
- Rheumatologic, neurologic, or degenerative disease
- Pregnancy
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
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실험적: Gait retraining group
Participants received a 6-week gait retraining program plus patient education. |
The intervention is a wearable device-assisted gait retraining program (home) designed specifically for female runners with patellofemoral pain. PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
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활성 비교기: Control group
Participants received a 6-week patient education program |
PFP education, load management strategies, symptom-based training modifications, and strengthening exercises |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analogue Scale for Pain during running
기간: Baseline, Week 6, Week 18
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The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated during running. |
Baseline, Week 6, Week 18
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Visual Analogue Scale for usual pain
기간: Baseline, Week 6, Week 18
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The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for usual pain. |
Baseline, Week 6, Week 18
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Anterior Knee Pain Scale
기간: Baseline, Week 6, Week 18
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The Anterior Knee Pain Scale (AKPS), also referred to as the Kujala Score, is a patient-reported outcome measure designed to evaluate symptoms and functional limitations associated with anterior knee pain and patellofemoral disorders. It consists of 13 items covering domains such as pain during various activities (e.g., walking, running, jumping, climbing stairs, squatting), functional limitations, abnormal gait, muscle atrophy, and difficulty with prolonged sitting. Each item is scored on an ordinal scale, and the total score ranges from 0 to 100, with higher scores indicating better knee function and fewer symptoms. |
Baseline, Week 6, Week 18
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Knee Flexion Angle
기간: Baseline, Week 6
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Peak knee flexion angle will be assessed during running trials using a 3-dimensional motion capture system. Reflective markers will be placed according to a standard lower-limb biomechanical model. |
Baseline, Week 6
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Ground Reaction Force
기간: Baseline, Week 6
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Ground reaction force (GRF) will be measured during overground running using embedded force plates synchronized with motion capture. |
Baseline, Week 6
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Visual Analogue Scale for the worst pain
기간: Baseline, Week 6, Week 18
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The Visual Analogue Scale (VAS) is a validated, widely used instrument for assessing subjective pain intensity. It consists of a 10-centimeter horizontal line, with one end (0) representing "no pain" and the other end (10) representing "worst imaginable pain." It will be evaluated for the worst pain. |
Baseline, Week 6, Week 18
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Step rates
기간: Baseline, Week 6
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Step rates refer to the number of steps taken per unit of time, usually expressed as steps per minute (steps/min). |
Baseline, Week 6
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Weekly running distance
기간: Baseline, Week 6
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Weekly running distance refers to the total distance covered by a participant through running over one week, usually expressed in kilometers (km) or meters (m). This outcome is used to assess running volume. |
Baseline, Week 6
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Haonan Wang, Beijing Sport University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 277S
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
What IPD will be shared:De-identified individual participant data that underlie the results reported in the publication, including baseline characteristics, outcome measures (pain scores, functional scores, running mechanics), and adverse events.
When will IPD be available:
Beginning 6 months after publication of the main trial results, for up to 5 years.
With whom:
Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
IPD 공유 기간
Beginning 6 months after publication of the main trial results, for up to 5 years.
IPD 공유 액세스 기준
With whom: Researchers who provide a methodologically sound proposal to achieve aims consistent with the original study.
For what types of analyses:
For individual participant data meta-analyses and reproducibility purposes.
How to access data:
Proposals should be directed to the corresponding author (wanghaonan@bsu.edu.cn). Data access will be provided via secure data transfer after approval of a data-sharing agreement.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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. .