Knee Care @Home Programme Feasibility Trial

University of Évora

Status: Not yet enrolling

Conditions: Anterior Cruciate Ligament Reconstruction

Treatments: Other: Knee Care @Home Programme

Study type: Observational

Funder types: Other

Identifiers

NCT06152380

KC@H Feasibility

Details and patient eligibility

About

The main goal of this trial is to determine the feasibility of a randomized controlled trial for the Knee Care at Home Programme, rather than the effectiveness, for patients recovering from anterior cruciate ligament reconstruction. Specifically, the trial aims to: (1) assess the feasibility of studying the effectiveness of the Knee Care at Home programme, including patient engagement and satisfaction; and (2) conduct a qualitative assessment to identify barriers and facilitators in the implementation and delivery of the programme.

Full description

Participants will be asked to take part in a 22-week intervention within a 24-week postoperative rehabilitation period following anterior cruciate ligament reconstruction. Internet-based remote sessions (3 times a week, 40 minutes per session) will supplement conventional clinic-based rehabilitation (face-to-face sessions). After the anterior cruciate ligament reconstruction, outcome measures are assessed during consultations with the orthopedic surgeon. These consultations occur after 4 weeks of intervention interval, except for the second postoperative consultation which occurs after a 2-week intervention period interval. Additional evaluations will occur during each remote session.

The team of researchers will evaluate the enrollment (screening, informed consent, eligibility, and allocation), data collection (response rates, missing data, and implementation and technical issues), intervention fidelity (adherence, adherence rate at remote sessions, adherence at conventional rehabilitation, quality of delivery, participant responsiveness, and safety), and acceptability (patient satisfaction and motivation).

Enrollment: 56 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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 disorders.
• Severe impairments in communication or balance.

Trial design

56 participants in 2 patient groups

Clinic-based Rehabilitation

Description:

Individualised clinic-based face-to-face sessions with a physiotherapist in public or private rehabilitation facility

Knee Care @Home

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