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

NCT05716529 | Completed

• 1 other identifier: 004257
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

ACL Injury; Rehabilitation After ACL Reconstruction; Accelerated Protocol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Knee Injury and Osteoarthritis Outcome Score

  22 weeks

• limb symmetry index of Hop test battery

  22 weeks

• knee effusion grading scale

  22 weeks

Study Arms (2)

accelerated rehabilitation protocol

EXPERIMENTAL

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

conventional physical therapy program

ACTIVE COMPARATOR

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

Interventions

rehabilitation protocol OTHER

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

accelerated rehabilitation protocol; conventional physical therapy program

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Delta University for Science and Technology: lead

Study Sites (1)

Delta university

Gamasa, Eldakahlyia, Egypt

Location

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Orthopedics

Study Record Dates

• First Submitted: January 28, 2023
• First Posted: February 8, 2023
• Study Start: March 6, 2022
• Primary Completion: April 16, 2023
• Study Completion: May 15, 2023
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)