The Knee Care @Home Programme Following Anterior Ligament Reconstruction

NCT ID: NCT05828355

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-01
• Study Completion Date: 2024-06-30

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.

Conditions

Anterior Cruciate Ligament Reconstruction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Clinic-based Rehabilitation

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Knee Care@Home

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.

Group Type: EXPERIMENTAL

Knee Care@Home Programme

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Synchronous internet-based remote sessions; Therapeutic Exercise

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Comprehensive Health Research Center

OTHER

Sponsor Role: collaborator

Fundação para a Ciência e a Tecnologia

OTHER

Sponsor Role: collaborator

Hospital da Misericórdia de Évora

UNKNOWN

Sponsor Role: collaborator

University of Évora

OTHER

Sponsor Role: lead

Responsible Party

Joao Paulo Brites de Sousa

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

João Paulo Sousa, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade de Évora - Comprehensive Health Research Center

Locations

Hospital da Misericórdia de Évora

Evora, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

João Paulo Sousa, PhD

Role: CONTACT

jsousa@uevora.pt

919662332

Nuno Batalha, PhD

Role: CONTACT

nmpba@uevora.pt

962435000

Facility Contacts

Gabriel Xavier, MD

Role: primary

gfxavier@hotmail.com

964551665

References

Alegrete J, Batalha N, Fernandes O, Parraca JA, Rodrigues AM, Londral AR, Sousa JP. Effectiveness of the KC@H programme compared with clinic-based rehabilitation in patients recovering from ACL reconstruction: a study protocol for a single-centre, two-arm, single-blinded, randomised controlled superiority trial. BMJ Open Sport Exerc Med. 2024 Feb 21;10(1):e001868. doi: 10.1136/bmjsem-2023-001868. eCollection 2024.

Reference Type: DERIVED

PMID: 38390383 (View on PubMed)

Other Identifiers

KC@H RCT

Identifier Type: -

Identifier Source: org_study_id