Functional Outcomes of a Criterion-based Rehabilitation Protocol for ACL Reconstruction in Amateur Athlete

February 8, 2023 updated by: Omar Mohamed Ali Elabd, Delta University for Science and Technology

Functional Outcomes of a Criterion-based Rehabilitation Protocol for Anterior Cruciate Ligament Reconstruction in Amateur Athlete: Randomized Controlled Trial

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Although current rehabilitation protocols following anterior cruciate ligament reconstruction (ACLR) are based on the graft remodeling process, there is uncertainty about its time schedule. Moreover, there are individual differences in neuromotor learning and flexibility after ACLR. This study was conducted to investigate the effect of a criterion-based rehabilitation protocol on pain intensity, effusion, and knee function in amateur athletes following ACLR.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

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

Genders Eligible for Study

Male

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: criterion-based rehabilitation protocol
Other: rehabilitation protocol
Current conventional protocols were based mainly on biological tissue healing time frames. These protocols emphasize pain reduction, full passive knee extension, quadriceps strength training, immediate motion, immediate par¬tial weight bearing (only if there is a correct gait pattern without any complications), and functional exercises The criterion-based rehabilitation protocol is relatively new. It was developed and recommended in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), aiming to assure a more patient-tailored rehabilitation and to maximize the speed of a patient's progress. It's a three phases protocol with a criterion-based progression.
ACTIVE_COMPARATOR: conventional physical therapy program
Other: rehabilitation protocol
Current conventional protocols were based mainly on biological tissue healing time frames. These protocols emphasize pain reduction, full passive knee extension, quadriceps strength training, immediate motion, immediate par¬tial weight bearing (only if there is a correct gait pattern without any complications), and functional exercises The criterion-based rehabilitation protocol is relatively new. It was developed and recommended in 2016 by the Royal Dutch Society for Physical Therapy (KNGF), aiming to assure a more patient-tailored rehabilitation and to maximize the speed of a patient's progress. It's a three phases protocol with a criterion-based progression.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: 6 months
It is a 100-mm horizontal line anchored by word descriptors at each end by "no pain" on the left and "worst imaginable pain" on the right
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
limb symmetry index of hop test battery
Time Frame: 6 months
The mean score of the results of each item of hop test battery of the injured limb was divided by the corresponding mean score of the uninjured limb and the result was multiplied by 100. Hop test battery consists of the following: (1) vertical jump, (2) hop for distance, (3) drop jump followed by a double hop for distance, (4) square hop and (5) side hop.
6 months
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 6 months
it is a 42-item self-questionnaire with five subscales. A five-point scale ranging from 0 (no problem) to 4 (extreme problems) was used to score each item and the scores of each subscale were individually transformed into a 0-100 scale (0 = extreme knee problems, 100 = no knee problem)
6 months
knee effusion grading scale
Time Frame: 6 months
It"s a reliable and valid method which Based on a stroke test, where effusion of the knee joint is quantified using a 5-point scale. A 0 grade means no wave is produced with the downward stroke
6 months

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)

March 3, 2020

Primary Completion (ACTUAL)

June 15, 2022

Study Completion (ACTUAL)

January 7, 2023

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 8, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DeltaU

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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