Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction
Effectiveness of a Digital Prehabilitation Programme Compared With Usual Care in Patients Awaiting Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Superiority Trial
Background Prehabilitation prior to anterior cruciate ligament reconstruction (ACLR) has been shown to improve preoperative knee function, enhance quadriceps strength, and optimize postoperative recovery. However, access to supervised prehabilitation programmes remains limited. Digital health interventions may improve accessibility, adherence, and continuity of care.
Objective To determine whether a structured digital prehabilitation programme is more effective than usual care in improving quadriceps strength and functional outcomes after ACL reconstruction.
Methods/design This study is a single-centre, parallel-group, assessor-blinded randomised controlled trial. Adult participants scheduled for primary ACL reconstruction will be randomly allocated to either a usual care group or a digital prehabilitation group. The intervention group will complete a 4-week structured digital prehabilitation programme prior to surgery. Outcomes will be assessed preoperatively and up to 12 weeks postoperatively.
Expected Results The digital prehabilitation programme is expected to improve preoperative knee status and enhance postoperative quadriceps strength and functional recovery compared to usual care.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: João Paulo Sousa, PhD
- 전화번호: 919662332
- 이메일: jsousa@uevora.pt
연구 연락처 백업
- 이름: Alejandro Caña Pino, PhD
- 전화번호: 927251220
- 이메일: alejandrocp@unex.es
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Adults 18-55 years
- Diagnosed ACL rupture
- Scheduled for primary ACL reconstruction
- Waiting ≥4 weeks before surgery
Exclusion Criteria:
- Multiligament injury
- Severe comorbidities
- Previous ACL surgery same knee
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Control Arm: Usual Care
Participants receive standard preoperative advice without a structured prehabilitation program
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Participants in the control group will receive standard preoperative care, which may include general advice and routine clinical follow-up, but no structured prehabilitation programme.Participants will not receive a supervised or digital exercise intervention prior to surgery.
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실험적: Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home Programme
Participants will complete a structured 4-week digital prehabilitation programme prior to ACL reconstruction, including: Range of motion exercises Strength training (quadriceps, hamstrings, hip musculature) Neuromuscular and balance training Patient education (surgery, recovery expectations) Lifestyle optimization (pain management, nutrition, emotional support) Frequency: 3 sessions per week Duration: 10-20 minutes per session Delivery mode: Digital platform with guided sessions and remote supervision. Knee Care@Home Programme |
Participants in the intervention group will undergo a structured 4-week digital prehabilitation programme prior to anterior cruciate ligament reconstruction.The programme includes:- Range of motion exercises targeting knee extension and flexion- Strength training focusing on quadriceps, hamstrings, and hip musculature- Neuromuscular and balance training- Patient education on surgical procedure, postoperative expectations, and recovery process- Lifestyle optimisation advice including pain management, nutrition, and emotional supportThe intervention will be delivered through a digital platform with guided exercise sessions and remote supervision.Frequency: 3 sessions per weekDuration: approximately 10-20 minutes per sessionThe programme aims to optimise preoperative knee function, improve quadriceps strength, and enhance postoperative recovery outcomes.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quadriceps Isometric Strength
기간: 12 weeks postoperative
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Maximum isometric quadriceps strength measured in seated position at 90° knee flexion.
Three repetitions will be recorded, and the highest value will be used
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12 weeks postoperative
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Knee Extension Range of Motion
기간: Baseline and preoperative (prior to surgery)
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Passive knee extension will be measured in degrees using a standard goniometer.
Full extension (0°) will be considered optimal preoperative status
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Baseline and preoperative (prior to surgery)
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Knee Pain Intensity
기간: Up to 12 weeks postoperative
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Pain intensity will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain)
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Up to 12 weeks postoperative
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Knee Injury and Osteoarthritis Outcome Score (KOOS)
기간: Up to 12 weeks postoperative
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Knee-related symptoms, pain, function in daily living, sport and recreation function, and knee-related quality of life will be assessed using the Knee Injury and Osteoarthritis Outcome Score (KOOS).
Each subscale is scored from 0 to 100, where 0 represents extreme problems and 100 represents no problems (best outcome).
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Up to 12 weeks postoperative
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Single Leg Hop Distance
기간: Up to 12 weeks postoperative
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Patients will perform a single-leg hop for maximum distance.
The distance will be measured in centimetres
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Up to 12 weeks postoperative
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Pain Catastrophizing
기간: Up to 12 weeks postoperative
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Pain-related catastrophic thinking will be assessed using the Pain Catastrophizing Scale (PCS).
The total score ranges from 0 to 52, where higher scores indicate greater levels of pain catastrophizing (worse outcome).
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Up to 12 weeks postoperative
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DASS-21. Depression, Anxiety and Stress
기간: Up to 12 weeks postoperative
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Psychological status will be assessed using the Depression Anxiety Stress Scales (DASS-21).
The scale consists of three subscales (depression, anxiety, and stress), each ranging from 0 to 42 after score multiplication.
Higher scores indicate greater emotional distress (worse outcome).
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Up to 12 weeks postoperative
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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 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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