- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07627724
ACL Prehabilitation and Functional Outcomes (ACL Prehab fun)
Preoperative Prehabilitation as a Predictor of Improved Functional Outcomes After Anterior Cruciate Ligament Reconstruction
연구 개요
상태
상세 설명
Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries among physically active individuals and is frequently managed with ACL reconstruction (ACLR). Despite advances in surgical techniques and postoperative rehabilitation, many patients continue to experience deficits in strength, neuromuscular control, and functional performance after surgery. Optimizing physical function before surgery may contribute to improved postoperative recovery. Preoperative rehabilitation, commonly referred to as prehabilitation, has been proposed as a strategy to enhance muscle strength, improve neuromuscular function, and prepare patients for postoperative rehabilitation. However, evidence regarding its effectiveness in improving functional outcomes following ACL reconstruction remains limited.
This prospective randomized controlled trial was designed to evaluate the impact of a structured six-week prehabilitation program on postoperative functional outcomes in individuals undergoing primary ACL reconstruction. Participants diagnosed with complete ACL rupture and scheduled for surgery were randomly assigned to either a prehabilitation group or a control group receiving standard preoperative care.
The prehabilitation program included progressive strengthening exercises, neuromuscular training, balance training, and functional movement exercises performed three times weekly under supervision. Participants were followed throughout the perioperative period and during postoperative rehabilitation.
Functional recovery was evaluated using validated patient-reported outcome measures and functional performance assessments at predefined time points before and after surgery. The study seeks to determine whether preoperative prehabilitation contributes to superior functional recovery and improved return-to-activity outcomes following ACL reconstruction.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Cairo, 이집트
- Outpatient clinics of the Faculty of Physical Therapy, Beni Suef University
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Male and female patients diagnosed with complete anterior cruciate ligament (ACL) rupture.
- Patients scheduled for primary anterior cruciate ligament reconstruction (ACLR).
- Age between 18 and 45 years.
- Medically fit to participate in a preoperative rehabilitation program.
- Willingness to participate in the study and provide informed consent.
- Ability to attend preoperative rehabilitation sessions regularly.
Exclusion Criteria:
- Previous surgery on the affected knee.
- Multiligament knee injuries other than isolated ACL rupture.
- Associated fractures around the knee joint.
- Severe meniscal or cartilage injuries requiring specific surgical management that may affect rehabilitation outcomes.
- Neurological disorders affecting lower limb function or balance.
- Systemic diseases that may interfere with rehabilitation (e.g., uncontrolled diabetes, severe cardiovascular disease).
- Inability to comply with the rehabilitation protocol or follow-up schedule.
- Refusal or inability to provide informed consent.
공부 계획
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 |
|---|---|
|
실험적: Prehabilitation program Group
Participants will receive a structured six-week preoperative prehabilitation program including strengthening, neuromuscular training, balance exercises, and functional training three times per week in addition to standard care.
|
A structured six-week preoperative rehabilitation program including progressive strengthening exercises, neuromuscular training, balance exercises, and functional movement training performed three times per week prior to anterior cruciate ligament reconstruction.
|
|
활성 비교기: standard preoperative care Control Group
Participants will receive standard preoperative care only without structured prehabilitation program.
|
Participants receive routine standard preoperative care without structured prehabilitation intervention.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
International Knee Documentation Committee (IKDC) Score
기간: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
The IKDC subjective knee form will be used to assess symptoms, function, and sports activity in patients undergoing ACL reconstruction.
Higher scores indicate better knee function.
|
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS)
기간: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
The KOOS is a patient-reported outcome measure used to assess knee-related symptoms, pain, activities of daily living, sports function, and quality of life following ACL reconstruction.
|
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
|
Tegner Activity Scale
기간: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
The Tegner Activity Scale is used to evaluate the level of physical activity and return to sports participation in patients after ACL reconstruction.
|
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
|
Single-Leg Hop Test
기간: Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
The Single-Leg Hop Test is used to assess functional performance, limb symmetry, and dynamic stability following ACL reconstruction.
|
Baseline, preoperatively, 3 months postoperatively, and 6 months postoperatively
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Sahar M Abdelmutilibe, PHD, Faculty of Physical Therapy, Beni Suef University, Cairo, Egypt
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
기타 연구 ID 번호
- FPTBSUREC/0312/15426
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .