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

ACL Injury Clinical Trial

— ACL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05716529
• Other study ID #: 004257
• Status: Completed
• Phase: N/A
• Start date: March 6, 2022
• Est. completion date: May 15, 2023

Study information

• Verified date: January 2024
• Source: Delta University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 15, 2023
• Est. primary completion date: April 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• ACL Injury
• Anterior Cruciate Ligament Injuries

Intervention

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

Locations

Country	Name	City	State
Egypt	Delta university	Gamasa	Eldakahlyia

Sponsors (1)

Lead Sponsor	Collaborator
Delta University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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