Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAlejandro Caña Pino

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults 18-55 years

Diagnosed ACL rupture

Scheduled for primary ACL reconstruction

Waiting ≥4 weeks before surgery

Disqualifiers

Multiligament injury

Severe comorbidities

Previous ACL surgery same knee

Trial design

Design model

Parallel

Treatments tested in this trial

  • Digital Prehabilitation Programme

    Other intervention

    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 intervention

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Control Arm: Usual CareActive comparator 1 intervention
Group B: Experimental Arm: Digital Prehabilitation Programme. Knee Care@Home ProgrammeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quadriceps Isometric Strength

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

Time frame
12 weeks postoperative

Secondary outcomes

1

Knee Extension Range of Motion

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

Time frame
Baseline and preoperative (prior to surgery)
2

Knee Pain Intensity

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

Time frame
Up to 12 weeks postoperative
3

Knee Injury and Osteoarthritis Outcome Score (KOOS)

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).

Time frame
Up to 12 weeks postoperative
4

Single Leg Hop Distance

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

Time frame
Up to 12 weeks postoperative

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alejandro Caña Pino

Lead sponsor

University of Extremadura

Sponsor institution

University of Extremadura

Collaborator

University of Évora

Collaborator

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