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Knee Care @Home Programme Feasibility Trial

NCT ID: NCT06152380

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-02-28

Brief Summary

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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

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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

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Anterior Cruciate Ligament Reconstruction

Keywords

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Feasibility Acceptability Barriers Facilitators Anterior Cruciate Ligament Reconstruction Internet-based Intervention Exercise Therapy Patient Satisfaction Patient Engagement

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Clinic-based Rehabilitation

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

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.

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

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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

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Synchronous internet-based remote sessions Therapeutic Exercises

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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

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Joao Paulo Brites de Sousa

Auxiliar Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Daniela Carmelo Pina, MSc

Role: CONTACT

Phone: 965732769

Email: [email protected]

João Paulo Sousa, PhD

Role: CONTACT

Phone: 919662332

Email: [email protected]

Other Identifiers

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KC@H Feasibility

Identifier Type: -

Identifier Source: org_study_id