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The Knee Care @Home Programme Following Anterior Ligament Reconstruction (KC@H)

U

University of Évora

Status

Enrolling

Conditions

Anterior Cruciate Ligament Reconstruction

Treatments

Other: Knee Care@Home Programme

Study type

Interventional

Funder types

Other

Identifiers

NCT05828355
KC@H RCT

Details and patient eligibility

About

Background: Patients who are unable to fully comply with conventional clinic-based rehabilitation sessions after anterior cruciate ligament reconstruction may find additional internet-based sessions beneficial. These remote sessions include therapeutic exercises that can be done at home, potentially extending the reach of rehabilitation services to underserved areas, prolonging the duration of care, and providing improved supervision.

Objective: To determine if the Knee Care at Home programme is more effective than conventional clinic-based rehabilitation alone in improving patient-reported, clinician-reported, and physical functional performance outcome measures after anterior cruciate ligament reconstruction. Additionally, the trial pursues to assess the significance of changes in outcome measures for clinical practice.

Methods/design: This protocol outlines a randomised controlled trial for postoperative recovery following anterior cruciate ligament reconstruction. Adult participants of both sexes who meet specific criteria will be randomly assigned to either the Clinic-based Rehabilitation group or the Knee Care at Home group. Only the latter group will receive internet-based sessions of therapeutic exercises at home, in addition to clinic-based rehabilitation sessions. A follow-up evaluation will be conducted for both groups 12 weeks after the intervention ends.

Expected Results: The Knee Care at Home programme is superior to conventional clinic-based rehabilitation alone for patients recovering from anterior cruciate ligament reconstruction across multiple outcome measures. Also, the programme has the potential to promote superior recovery and extend the reach and duration of care.

Enrollment

56 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Undergone primary ACLR regardless of surgical method and choice of autograft.
  • Have a healthy contralateral (opposite) knee.
  • The time between ACL injury and ACLR should not exceed 12 months.

Exclusion criteria

  • Declined to participate.
  • Concomitant osteochondral injuries.
  • Undergone multiple reconstructions of the lateral collateral ligament or posterior cruciate ligament.
  • Significant lower limb injuries within the 12 months before the ACL injury.
  • Medical conditions that may affect recovery.
  • Using medication for mental health disorders.
  • Severe impairments in communication or balance.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

56 participants in 2 patient groups

Clinic-based Rehabilitation
No Intervention group
Description:
Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility
Knee Care@Home
Experimental group
Description:
Individualised synchronous internet-based remote sessions at home via conferencing software under the supervision of a certified exercise and health coach as a complement to conventional clinic-based rehabilitation sessions.
Treatment:
Other: Knee Care@Home Programme

Trial contacts and locations

1

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Central trial contact

Nuno Batalha, PhD; João Paulo Sousa, PhD

Data sourced from clinicaltrials.gov

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