Back to resultsBiomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction
Primary Purpose
Knee Injuries, Rehabilitation
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rehabilitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries
Eligibility Criteria
Inclusion Criteria: Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft. Ranging in age from 18 to 35 years. Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility Ability to actively control the quadriceps. Exclusion Criteria: ACLR with any graft other than a hamstring graft ACL revision surgery associated medial or lateral ligamentous injuries previous meniscectomy or meniscal repair simultaneous meniscectomy or meniscus repair with the ACLR cartilage damage.
Sites / Locations
- Delta university
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
criterion-based rehabilitation protocol
accelerated rehabilitation protocol
Arm Description
It's a three phases rehabilitation protocol with a goal-based progression which include a three criterion based postoperative phases: (1) impairment phase, (2) sport-specific training phase and (3) return to play phase. Patients can start with the next phase only if specific goals of the previous phase are achieved
It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises
Outcomes
Primary Outcome Measures
Dynamic knee valgus during Single leg landing-jump test using kinovea software
From the coronal plane, dynamic knee valgus is the angle between femoral longitudinal axis and the extension of the longitudinal tibial axis.
Lateral trunk flexion during Single leg landing-jump test using kinovea software
From the coronal plane, trunk lateral flexion angle is the angle between the vertical median axis of the body and the longitudinal median axis of the upper trunk
knee flexion angle during Single leg landing-jump test using kinovea software
From sagittal plane, knee flexion angle is the angle between the longitudinal axis of the femur and the extension of the longitudinal axis of the tibia
Secondary Outcome Measures
Full Information
NCT ID
NCT05733936
First Posted
January 28, 2023
Last Updated
February 8, 2023
Sponsor
Delta University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05733936
Brief Title
Biomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction
Official Title
Assessment of Biomechanical Determinants of Rehabilitation Protocols for ACL Reconstruction on the Quality of Performance and Risk of Reinjury: Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 20, 2023 (Anticipated)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Delta University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purpose of the study is to investigate the effects of the criterion rehabilitation protocol versus accelerated rehabilitation protocol on the biomechanical determinants of the quality of performance and risk of reinjury.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries, Rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
criterion-based rehabilitation protocol
Arm Type
Experimental
Arm Description
It's a three phases rehabilitation protocol with a goal-based progression which include a three criterion based postoperative phases: (1) impairment phase, (2) sport-specific training phase and (3) return to play phase. Patients can start with the next phase only if specific goals of the previous phase are achieved
Arm Title
accelerated rehabilitation protocol
Arm Type
Active Comparator
Arm Description
It's a four phases rehabilitation protocol mainly based on the remodeling process of the graft., emphasizing full passive knee extension, immediate weight bearing as tolerated and functional exercises
Intervention Type
Other
Intervention Name(s)
rehabilitation protocol
Intervention Description
rehabilitation protocols after ACLR have been described, aiming to improve muscle strength and knee stability through muscle strengthening exercises in addition to exercises to improve joint proprioception
Primary Outcome Measure Information:
Title
Dynamic knee valgus during Single leg landing-jump test using kinovea software
Description
From the coronal plane, dynamic knee valgus is the angle between femoral longitudinal axis and the extension of the longitudinal tibial axis.
Time Frame
15 min
Title
Lateral trunk flexion during Single leg landing-jump test using kinovea software
Description
From the coronal plane, trunk lateral flexion angle is the angle between the vertical median axis of the body and the longitudinal median axis of the upper trunk
Time Frame
15 min
Title
knee flexion angle during Single leg landing-jump test using kinovea software
Description
From sagittal plane, knee flexion angle is the angle between the longitudinal axis of the femur and the extension of the longitudinal axis of the tibia
Time Frame
15 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Amateur male athletes who underwent ACLR surgery with an autologous hamstring (HS) graft.
Ranging in age from 18 to 35 years.
Underwent a pre-operative rehabilitation program with minimal knee effusion, full Extension, good patellofemoral mobility
Ability to actively control the quadriceps.
Exclusion Criteria:
ACLR with any graft other than a hamstring graft
ACL revision surgery
associated medial or lateral ligamentous injuries
previous meniscectomy or meniscal repair
simultaneous meniscectomy or meniscus repair with the ACLR
cartilage damage.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar M Elabd, PHD
Phone
+201098221045
Email
omar.elabd@deltauniv.edu.eg
Facility Information:
Facility Name
Delta university
City
Gamasa
State/Province
Eldakahlyia
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Biomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction
We'll reach out to this number within 24 hrs