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NCT Number: NCT07643480

Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

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.

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Key information

Conditions

Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Injuries Knee Injuries Leg Injuries Wounds and Injuries

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital Prehabilitation Programme

Other

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.

Usual Care

Other

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.

Primary outcomes

  1. Quadriceps Isometric Strength

    Time frame: 12 weeks postoperative

    Maximum isometric quadriceps strength measured in seated position at 90° knee flexion. Three repetitions will be recorded, and the highest value will be used

Secondary outcomes

  1. Knee Extension Range of Motion

    Time frame: Baseline and preoperative (prior to surgery)

    Passive knee extension will be measured in degrees using a standard goniometer. Full extension (0°) will be considered optimal preoperative status

  2. Knee Pain Intensity

    Time frame: Up to 12 weeks postoperative

    Pain intensity will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (worst imaginable pain)

  3. Knee Injury and Osteoarthritis Outcome Score (KOOS)

    Time frame: Up to 12 weeks postoperative

    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).

  4. Single Leg Hop Distance

    Time frame: Up to 12 weeks postoperative

    Patients will perform a single-leg hop for maximum distance. The distance will be measured in centimetres

  5. Pain Catastrophizing

    Time frame: Up to 12 weeks postoperative

    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).

  6. DASS-21. Depression, Anxiety and Stress

    Time frame: Up to 12 weeks postoperative

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Alejandro Caña Pino, PhD

CONTACT

[email protected]

927251220

João Paulo Sousa, PhD

CONTACT

[email protected]

919662332

Sponsors and collaborators

Lead sponsor

Alejandro Caña Pino

Other

Collaborators

  • University of Extremadura
  • University of Évora

Registry information

Official study title

Effectiveness of a Digital Prehabilitation Programme Compared With Usual Care in Patients Awaiting Anterior Cruciate Ligament Reconstruction: A Randomised Controlled Superiority Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 11, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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