Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

June 8, 2026 updated by: Alejandro Caña Pino

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm: Usual Care
Participants receive standard preoperative advice without a structured prehabilitation program
Other: Usual Care
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.
Experimental: 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
Other: Digital Prehabilitation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks postoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline and preoperative (prior to surgery)
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)
Up to 12 weeks postoperative
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).
Up to 12 weeks postoperative
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
Up to 12 weeks postoperative
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).
Up to 12 weeks postoperative
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).
Up to 12 weeks postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alejandro Caña Pino

Collaborators

University of Extremadura
University of Évora

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2026

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

June 1, 2026

First Submitted That Met QC Criteria

June 8, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010626

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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