Clinical trial NCT05828355: The Knee Care @Home Programme Following Anterior Ligament Reconstruction
Official title: Effectiveness of the KC@H Programme Compared With Clinic-based Rehabilitation in Patients Recovering From Anterior Cruciate Ligament Reconstruction: Study Protocol for a Single-centre, Randomised Controlled Superiority Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anterior Cruciate Ligament Reconstruction
Keywords: Anterior Cruciate Ligament Reconstruction
Patient-reported Outcomes Measures
Clinician-reported Outcomes Measures
Functional Performance
Clinical Relevance
Internet-based Intervention
Exercise Therapy
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: 2023-04-25
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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 health disorders.
* Severe impairments in communication or balance.

Primary outcomes:
measure: Standing height
timeFrame: Preoperative consultation
measure: Weight
timeFrame: up to 36 weeks postoperative
measure: Knee pain during the last 24 hours
timeFrame: up to 36 weeks postoperative
measure: Knee pain during the last week
timeFrame: up to 36 weeks postoperative
measure: Knee symptoms and stiffness during the last week
timeFrame: up to 36 weeks postoperative
measure: Knee-related physical function during the last week
timeFrame: up to 36 weeks postoperative
measure: Knee function in daily living, sports, and recreational activities during the last week
timeFrame: up to 36 weeks postoperative
measure: Knee-related quality of life
timeFrame: up to 36 weeks postoperative
measure: Knee joint effusion
timeFrame: up to 36 weeks postoperative
measure: Passive knee flexion and extension range of motion
timeFrame: up to 36 weeks postoperative
measure: Knee extensor and flexor muscle length
timeFrame: up to 36 weeks postoperative
measure: Knee extensor and flexor isometric muscle strength
timeFrame: up to 36 weeks postoperative
measure: Knee pain catatrophising
timeFrame: up to 36 weeks postoperative
measure: Anxiety, depression, and stress during last week
timeFrame: up to 36 weeks postoperative
measure: Hop distance on a single leg
timeFrame: up to 36 weeks postoperative
measure: Ability to ascend and descend a flight of stairs (12 steps)
timeFrame: up to 36 weeks postoperative
Secondary outcomes:
measure: Symptom State
timeFrame: up to 36 weeks postoperative
measure: Clinical Benefit
timeFrame: up to 36 weeks postoperative
measure: Clinical Difference
timeFrame: up to 36 weeks postoperative
Other outcomes:
Locations:
city: Évora
country: Portugal
facility: Hospital da Misericórdia de Évora
Study officials:
affiliation: Universidade de Évora - Comprehensive Health Research Center
name: João Paulo Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References: