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Not yet recruiting NCT07643480

Effectiveness of a Digital Prehabilitation Programme Before ACL Reconstruction

No phase Interventional Anterior Cruciate Ligament Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital Prehabilitation Programme, Usual Care.
Who it may be relevant to
Registry conditions: Anterior Cruciate Ligament Injury. Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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 managem
  • 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.

Primary outcome measures

  • Quadriceps Isometric Strength [Time frame: 12 weeks postoperative]
Secondary outcome measures (6)
  • Knee Extension Range of Motion [Time frame: Baseline and preoperative (prior to surgery)]
  • Knee Pain Intensity [Time frame: Up to 12 weeks postoperative]
  • Knee Injury and Osteoarthritis Outcome Score (KOOS) [Time frame: Up to 12 weeks postoperative]
  • Single Leg Hop Distance [Time frame: Up to 12 weeks postoperative]
  • Pain Catastrophizing [Time frame: Up to 12 weeks postoperative]
  • DASS-21. Depression, Anxiety and Stress [Time frame: Up to 12 weeks postoperative]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07643480 · 010626

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗