Functional Outcomes of an Accelerated Rehabilitation Protocol for ACL Reconstruction in Amateur Athletes (ACL)

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

The main goal of a rehabilitation program after an ACL reconstruction is to regain mobility and muscle function and ultimately to return to sports participation. Purpose of the study: to investigate the effect of the accelerated rehabilitation program on knee pain, and function in patients post ACLR surgery. Fifty adult amateur males athletes who underwent ACLR surgery participated in this study, their age ranged from 18 to 35years.They were randomly assigned into two equal groups. Group (A) received accelerated rehabilitation protocol and group (B) received conventional physical therapy program. Treatment sessions were conducted 5 times per week for 22 weeks for both groups. All patients assessed pre and post treatment for pain intensity using visual analogue scale (VAS), and knee function using knee injury and osteoarthritis outcome score (KOOS), knee effusion, and LSI of Hop test.

Study Overview

• Status: Completed
• Conditions: ACL Injury; Rehabilitation After ACL Reconstruction; Accelerated Protocol
• 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

Description

Inclusion Criteria:

• Patients were participated in this study if they fulfilled the following criteria:

  • Underwent pre-operative rehabilitation program with minimal knee effusion and full extension, good patellofemoral mobility, and the patient can actively control the quadriceps.
  • Have an ACLR with an autolongous hamstring (HT) graft.
  • Age range from 18-40 years old.
  • Football players or who perform physically demanding work.
  • Have no other ligamentous injury.
  • Have nomeniscectomy previous to or simultaneouswith ACLR.
  • Have no cartilage damage.

Exclusion Criteria:

• • Patients younger than 18 or older than 35 years old

  • Have ACLR with any graft other than hamstring (HT) graft
  • Have ACL revision surgery
  • Have other ligamentous injury
  • Have a meniscectomy previous to or simultaneous with ACLR.
  • Had meniscal repair simultaneously with ACLR
  • Have cartilage damage.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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; 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
Active Comparator: conventional physical therapy program; 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	Other: 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

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	22 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	22 weeks
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	22 weeks
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	22 weeks

Collaborators and Investigators

• Sponsor: Delta University for Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2022
• Primary Completion (Actual): April 16, 2023
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: January 28, 2023
• First Submitted That Met QC Criteria: January 28, 2023
• First Posted (Actual): February 8, 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: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: 004257

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