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

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: Anterior Cruciate Ligament Injuries; Knee Ligament Injury
• Intervention / Treatment: Other: rehabilitation protocol

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

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	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	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	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	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

• Sponsor: Delta University for Science and Technology

Study record dates

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: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• 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