Biomechanical Determinants of Different Rehabilitation Protocols for ACL Reconstruction

January 20, 2024 updated by: Omar Mohamed Ali Elabd, Delta University for Science and Technology

Assessment of Biomechanical Determinants of Rehabilitation Protocols for ACL Reconstruction on the Quality of Performance and Risk of Reinjury: Randomized Controlled Trial

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Eldakahlyia
      • Gamasa, Eldakahlyia, Egypt
        • Delta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: criterion-based rehabilitation protocol
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
Other: rehabilitation protocol
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
Active Comparator: accelerated rehabilitation protocol
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
Other: rehabilitation protocol
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic knee valgus during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time Frame: 15 minutes
From the coronal plane, dynamic knee valgus is the angle of the knee
15 minutes
Lateral trunk flexion during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time Frame: 15 minutes
From the coronal plane, trunk lateral flexion angle is the angle of the trunk
15 minutes
knee flexion angle during Single leg landing-jump test using CLINICAL CLIMA 3DMA
Time Frame: 15 minutes
From sagittal plane, knee flexion angle is the angle of the knee
15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Delta University for Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (Actual)

February 17, 2023

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004270

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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