Ignite Creation Date:
2024-05-06 @ 6:53 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05828355
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2023-03-17
Brief Title:
The Knee Care Home Programme Following Anterior Ligament Reconstruction
Sponsor:
University of Évora
Organization:
University of Évora
Study Overview
Official Title:
Effectiveness of the KCH Programme Compared With Clinic-based Rehabilitation in Patients Recovering From Anterior Cruciate Ligament Reconstruction Study Protocol for a Single-centre Randomised Controlled Superiority Trial
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KCH
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
Methodsdesign 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
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
Methodsdesign 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None