Clinical trial NCT06152380: Knee Care @Home Programme Feasibility Trial
Official title: Implementation of the Knee Care @Home Programme for Patients Recovering Anterior Cruciate Ligament Reconstruction: Protocol for a Randomised Feasibility Trial
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Feasibility
Acceptability
Barriers
Facilitators
Anterior Cruciate Ligament Reconstruction
Internet-based Intervention
Exercise Therapy
Patient Satisfaction
Patient Engagement
Lead sponsor: University of Évora
Sponsor class: OTHER
Collaborators: name: Comprehensive Health Research Center
name: Fundação para a Ciência e a Tecnologia
name: Hospital da Misericórdia de Évora
First posted: 2023-11-30
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone anterior cruciate ligament reconstruction at Hospital da Misericórdia de Évora.

Brief 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).

Eligibility 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.

Primary outcomes:
measure: Enrolment: Screening
timeFrame: Preoperative consultation
measure: Enrolment: Informed Consent
timeFrame: Preoperative consultation
measure: Enrolment: Eligibility
timeFrame: First consultation after surgery (second week)
measure: Enrolment: Allocation
timeFrame: First consultation after surgery (second week)
measure: Data Collection: Response rates
timeFrame: Up to 36 weeks postoperative
measure: Data Collection: Missing data
timeFrame: Up to 36 weeks postoperative
measure: Data Collection: Implementation and Technical issues
timeFrame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
measure: Intervention Fidelity: Adherence to the trial
timeFrame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
measure: Intervention Fidelity: Adherence rate at Remote sessions
timeFrame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
measure: Intervention Fidelity: Adherence rate at Conventional Clinic-based Rehabilitation
timeFrame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
measure: Intervention Fidelity: Quality of delivery
timeFrame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
measure: Intervention Fidelity: Participant Responsiveness
timeFrame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
measure: Intervention Fidelity: Safety (adverse events)
timeFrame: During each remote session, there will be a total of 22 weeks with 42 sessions between the 2nd and 24th postoperative week.
measure: Acceptability: Satisfaction
timeFrame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
measure: Acceptability: Motivation
timeFrame: During each orthopaedic consultation, there will be a total of 7 consultations on the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th postoperative weeks, spanning a total of 22 weeks.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: