NCT06152380

Knee Care @Home Programme Feasibility Trial

Implementation of the Knee Care @Home Programme for Patients Recovering Anterior Cruciate Ligament Reconstruction: Protocol for a Randomised Feasibility Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 56 (estimated)
• Sponsor: University of Évora · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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).

Conditions

• Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
OTHER	Knee Care @Home Programme	Over 24 weeks after undergoing surgical reconstruction of the anterior cruciate ligament, patients in the intervention group will receive supervised guidance on therapeutic exercises to be performed at home. This guidance will be provided through individualised synchronous internet-based remote sessions using conferencing software.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-01-30
• Completion: 2024-02-28
• First posted: 2023-11-30
• Last updated: 2023-11-30